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Last update 16 May 2025

Spesolimab

Last update 16 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Immunoglobulin G1, anti-(human interleukin 36 receptor) (humanized monoclonal BI 655130 gamma1-chain), disulfide with humanized monoclonal BI 655130 kappa-chain, dimer, Spesolimab (genetical recombination) (JAN), Spesolimab (INN)

+ [9]

Target

IL-36R

Action

inhibitors

Mechanism

IL-36R inhibitors(Interleukin-36 receptor inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesOther Diseases+ [2]

Active Indication

Pustular psoriasisGeneralized Pustular PsoriasisPyoderma Gangrenosum+ [2]

Inactive Indication

Colitis, UlcerativeCrohn DiseaseDermatitis, Atopic+ [5]

Originator Organization

Boehringer Ingelheim International GmbH

Active Organization

Boehringer Ingelheim GmbHBoehringer Ingelheim International GmbHBoehringer Ingelheim Pharmaceuticals, Inc.

+ [6]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (01 Sep 2022),

Generalized Pustular Psoriasis

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea), Orphan Drug (Australia), Orphan Drug (Switzerland), Breakthrough Therapy (Taiwan Province), Priority Review (United States)

Structure/Sequence

Sequence Code 176702L

Source: *****

Sequence Code 9071670H

Source: *****

Clinical Trials associated with Spesolimab

NCT06886009

/ Not yet recruitingNot Applicable

A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Spesolimab in Korean Patients With Flares With Generalized Pustular Psoriasis

The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.

Start Date27 Jun 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

CTR20244695

/ RecruitingPhase 3

一项在需要全身治疗的成人溃疡型坏疽性脓皮病（PG）患者中评价佩索利单抗（BI 655130）的安全性和有效性的多中心、随机、安慰剂对照、双盲、平行组试验

[Translation] A multicenter, randomized, placebo-controlled, double-blind, parallel-group trial to evaluate the safety and efficacy of pesolimumab (BI 655130) in adult patients with ulcerative pyoderma gangrenosum (PG) requiring systemic therapy

本试验拟在溃疡型PG试验受试者中评价佩索利单抗重复给药相比安慰剂（两种药物均联合口服皮质类固醇：天泼尼松或泼尼松龙）的安全性、有效性、PK和免疫原性。主要目的是证明在第26周前任何时间目标PG溃疡达到完全闭合（PG面积减少100%，PGAR-100）的试验受试者比例差异方面，佩索利单抗优效于安慰剂。次要目的是证明佩索利单抗在（关键）次要终点方面优效于安慰剂。

[Translation]

This trial is intended to evaluate the safety, efficacy, PK, and immunogenicity of repeated dosing of pesolizumab versus placebo (both drugs combined with oral corticosteroids: prednisone or prednisolone) in ulcerative PG trial subjects. The primary objective is to demonstrate the superiority of pesolizumab to placebo in the difference in the proportion of trial subjects with complete closure of the target PG ulcer (100% reduction in PG area, PGAR-100) at any time before Week 26. The secondary objective is to demonstrate the superiority of pesolizumab to placebo in (key) secondary endpoints.

Start Date20 Feb 2025

Sponsor / Collaborator

Boehringer Ingelheim (China) Investment Co., Ltd.

[+2]

NCT06624670

/ RecruitingPhase 3

A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm^2 to 80 cm^2 in size.
This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth.
In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab.
In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks.
Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Start Date04 Feb 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Spesolimab

100 Translational Medicine associated with Spesolimab

100 Patents (Medical) associated with Spesolimab

136

Literatures (Medical) associated with Spesolimab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful treatment of generalized pustular psoriasis during pregnancy with secukinumab in a patient hypersensitive to spesolimab: a case report

Article

Author: Zhang, Yun ; Peng, Guoyao ; Nie, Xinyi ; Zhang, Hongwei ; Yu, Tao ; Liao, Chengcheng ; Li, Xia ; Xiang, Jie ; Luo, Jiaxin ; Luo, Liping ; Li, You ; Zhang, Shuang

OBJECTIVE:

Generalized pustular psoriasis (GPP) is a rare autoinflammatory skin disease characterized by recurrent, widespread eruption of sterile pustules rich in neutrophils. In addition to skin manifestations, this condition may be accompanied by fever, muscle pain, joint pain, systemic inflammation, or organ failure. GPP during pregnancy poses a serious threat to both mother and fetus, with limited options for medication. This study aimed to evaluate the safety of secukinumab during pregnancy as a treatment option for psoriasis.

MATERIALS AND METHODS:

We report the case of a 35-year-old pregnant woman presenting with extensive, confluent erythematous scaly plaques and numerous pustules, accompanied by fever. Over the past few years, her lesions showed remission following treatment with corticosteroids, traditional Chinese medicine, and secukinumab. However, after a brief remission with spesolimab, the lesions recurred and no significant improvement was obtained with glucocorticoid therapy. Secukinumab treatment was then initiated.

RESULTS:

Secukinumab was administered subcutaneously at a dose of 300 mg at weeks 0, 1, 2, 3, 4, and 8. Following treatment, GPP symptoms were reduced, and fetal development remained normal. A healthy boy was delivered vaginally at term.

CONCLUSION:

Our findings provide evidence that secukinumab is an effective and safe treatment option for GPP during pregnancy.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Expanding the therapeutic horizons of spesolimab: a review of off-label applications for inflammatory skin diseases

Review

Author: Zhang, Hanlin ; Tang, Keyun ; Zhang, Xinyi ; Zhou, Jia ; Jin, Hongzhong

PURPOSE:

This review aims to outline the crucial role of IL-36 signaling in inflammatory skin diseases and summarize the therapeutic potential of spesolimab. Our goal is to provide insights into the off-label applications of spesolimab and future directions for its use in treating other challenging skin diseases.

MATERIALS AND METHODS:

We conducted a comprehensive literature search across PubMed, Embase, Web of Science, MEDLINE, Scopus, and the Cochrane Library to identify relevant studies. For RCTs, we additionally searched the ClinicalTrials.gov database.

RESULTS:

In this review, we examine its off-label applications for conditions such as palmoplantar pustulosis, acrodermatitis continua of Hallopeau, hidradenitis suppurativa, pyoderma gangrenosum, and acute generalized exanthematous pustulosis. This review also explores the role of IL-36 in the pathophysiology of these disorders and discusses how spesolimab may address the limitations of current therapies for refractory cases. Randomized controlled trials and case reports are summarized to highlight the efficacy and tolerability of spesolimab across various inflammatory skin conditions. We highlight the challenges presented by the absence of standardized treatment guidelines and the need for larger clinical trials.

CONCLUSIONS:

This review underscores the potential of spesolimab to enhance treatment strategies for inflammatory skin diseases.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful treatment of etanercept- and adalimumab-resistant pyoderma gangrenosum with spesolimab, moderate-dose corticosteroids, and minocycline

Article

Author: Zhang, Hanlin ; Wu, Chao ; Jin, Hongzhong

PURPOSE:

Pyoderma gangrenosum (PG) is a rare, neutrophilic dermatosis characterized by rapidly developing, painful ulcers. This study explores the potential of spesolimab, an anti-IL-36R antibody, as a therapeutic option for refractory PG.

MATERIALS AND METHODS:

We report a case of a 48-year-old male with refractory PG who failed to respond to etanercept and adalimumab. Upon admission, the patient presented with extensive, painful ulcerations on the trunk and extremities. He was started on oral methylprednisolone (32 mg/day) and minocycline (50 mg twice daily). After a week, minimal improvement was observed. After reviewing the screening results and discussing treatment options, the patient received two doses of spesolimab (900 mg intravenously) administered two weeks apart.

RESULTS:

Marked clinical improvement was observed after spesolimab initiation. Complete ulcer healing was achieved within six weeks of starting spesolimab, with no adverse effects reported.

CONCLUSIONS:

This case demonstrates the potential efficacy of spesolimab for treating refractory PG, particularly in patients unresponsive to TNF-α inhibitors. Despite the added complexity of the patient's underlying HBV infection and elevated M-protein, no HBV reactivation or other hematologic complications occurred. Further studies are needed to validate its role in managing PG and other neutrophilic dermatoses.

News (Medical) associated with Spesolimab

07 Mar 2025

·www.prnewswire.com

New analyses on the potential impact of SPEVIGO® in generalized pustular psoriasis patient-reported outcomes presented at AAD 2025

Improvements in Psoriasis Symptom Scale (PSS), Pain Visual Analog Scale (VAS) and Dermatology Life Quality Index (DLQI) scores were observed in post-hoc exploratory analyses of the EFFISAYIL® 2 trial Findings suggest the potential benefit of continuously treating generalized pustular psoriasis (GPP) with subcutaneous spesolimab RIDGEFIELD, Conn., March 7, 2025 /PRNewswire/ -- Today, Boehringer Ingelheim announced new analyses to be presented at the American Academy of Dermatology (AAD) annual meeting in Orlando that explore the effect that SPEVIGO® (spesolimab-sbzo) may have on the physical symptoms and mental health burden associated with generalized pustular psoriasis (GPP). These post-hoc exploratory analyses from the EFFISAYIL® 2 clinical trial assessed the efficacy and safety of subcutaneous SPEVIGO in patients suffering from GPP.1,2 Distinct from plaque psoriasis, GPP is a serious and rare, chronic, heterogenous, inflammatory neutrophilic disease associated with painful skin manifestations and systemic symptoms, such as fever, pain, and fatigue.3-6 GPP's unpredictable nature can potentially have significant long-term impacts on quality of life for people living with it and may cause fear and anxiety over the disease course.5,7 "Generalized pustular psoriasis profoundly affects patients' physical and mental well-being, often disrupting their education, careers, and personal relationships. We are encouraged by the improvements observed in patient-reported outcomes with spesolimab. These studies strengthen our commitment to delivering innovative treatments for those living with severe dermatological conditions like GPP," says Vicky Brown, Senior Vice President and Head of Immunology, Oncology, and Eye Health, Boehringer Ingelheim Pharmaceuticals, Inc. In the EFFISAYIL 2 clinical trial, patients with a history of GPP were randomized to receive one of three active treatment regimens or a placebo. Participants were asked to rate their GPP symptoms – including pain, redness, itching, and burning – using the Psoriasis Symptom Scale (PSS), the Pain Visual Analog Scale (VAS), and the Dermatology Life Quality Index (DLQI). The PSS ranges from 0 to 16, while the Pain VAS ranges from 0 to 100, with higher scores indicating more severe symptoms. Of the 30 patients randomized to receive subcutaneous spesolimab, 300 mg every four weeks after a 600mg loading dose, participants reported a reduction in mean Pain VAS scores over the course of the trial, with more than half (56.5%) of patients reporting a Pain VAS score of 0 at Week 48 and the mean PSS score decreasing from 5.34 to 2.96 by Week 48. Patients were also asked to rate the impact of GPP through a 10-item questionnaire to assess changes in quality of life using the DLQI. The results found that mean DLQI scores improved from a "very large effect on patient's life" score (11.14) at baseline to a "small effect on patient's life" score (4.57) at week 48 following treatment with SPEVIGO. Measurable improvements in mean PSS, Pain VAS and DLQI scores were observed by the first assessment at Week 4. "The results from EFFISAYIL 2 provide valuable insights into the chronicity of generalized pustular psoriasis," said Dr. Tina Bhutani, study author. "The data are a pivotal step in advancing patient-centered care in GPP." These findings may provide healthcare professionals with data that can help inform their choice of treatment regimens for people living with GPP. About SPEVIGO® SPEVIGO® is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP. What is SPEVIGO®? SPEVIGO® is a prescription medicine used to treat generalized pustular psoriasis (GPP) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). It is not known if SPEVIGO® is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40kg). Important Safety Information Do not receive SPEVIGO® if you or your child have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO®. What is the most important information I should know about SPEVIGO®? SPEVIGO® may cause serious side effects, including: Infections. SPEVIGO® may lower the ability of your or your child's immune system to fight infections and may increase your or your child's risk of infections. Your healthcare provider should check you or your child for infections and tuberculosis (TB) before starting treatment with SPEVIGO® and may treat you or your child for TB before you begin treatment with SPEVIGO® if you have a history of TB or have active TB. Your healthcare provider should watch you or your child closely for signs and symptoms of TB during or after treatment with SPEVIGO®. Tell your healthcare provider right away if you or your child have an infection or have symptoms of an infection during or after treatment with SPEVIGO®, including: fevers, chills, or sweats muscle aches cough shortness of breath blood in your phlegm (mucus) burning when you urinate urinating more often than normal Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your or your child's SPEVIGO® injection. If you or your child have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO®. If you or your child are given SPEVIGO® in a vein (intravenously) and have an infusion- related reaction, your healthcare provider will stop your or your child's SPEVIGO® infusion and treat your or your child's symptoms and may restart SPEVIGO® at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you or your child get any of the following symptoms during or after your or your child's SPEVIGO® injection: feeling faint, dizzy, or lightheaded swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness fever mouth sores chest tightness hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP) itching swollen lymph nodes Before you or your child receive SPEVIGO®, tell your healthcare provider about all of your medical conditions, including if you or your child: have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You or your child should not receive live vaccines during and for at least 16 weeks after treatment with SPEVIGO®. You or your child should be brought up to date with all vaccines before starting SPEVIGO®. are pregnant or plan to become pregnant. It is not known if SPEVIGO® can harm your or your child's unborn baby. are breastfeeding or plan to breastfeed. It is not known if SPEVIGO® passes into your breast milk. Talk to your healthcare provider about the best way to feed your or your child's baby during treatment with SPEVIGO®. Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of SPEVIGO®? The most common side effects of SPEVIGO® given in a vein (intravenously) for GPP flare treatment include: feeling tired or weak nausea and vomiting headache itching or itchy bumps a collection of blood under the skin at the infusion site or bruising urinary tract infection The most common side effects of SPEVIGO® when given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare include: redness, pain, swelling, hardening, hives, or warmth at the injection site joint pain urinary tract infection itching These are not all of the possible side effects of SPEVIGO®. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1 ‐ 800 ‐ FDA ‐ 1088. Please see full Prescribing Information , Medication Guide, and Instructions for Use . About the EFFISAYIL® clinical trial program The EFFISAYIL® clinical trial program evaluated the largest and broadest population of GPP patients in trials of a therapy specifically targeting the IL-36 pathway for GPP: EFFISAYIL® 1: A Phase II study that demonstrated treatment with a single intravenous dose of spesolimab significantly improved signs and symptoms of GPP in patients experiencing a flare, including rapid pustular and skin clearance. These results supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets EFFISAYIL® 2: A Phase IIb study that showed spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. In the trial with 123 patients, no flares were observed after week 4 of spesolimab SC treatment in the high-dose group (n=30) EFFISAYIL® ON: An open-label extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP who have completed previous spesolimab trials About generalized pustular psoriasis GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment. Prevalence of GPP is low and varies considerably across geographical regions, ranging from 1.76 to 124 patients per million persons in reports from key countries, including France, Japan, Sweden, and South Korea. GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems. GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient's quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances. About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at . 1Bhutani T, et al. Spesolimab improves quality of life as measured by Psoriasis Symptom Scale (PSS) and Pain Visual Analog Scale (VAS) in generalized pustular psoriasis (GPP) over time: Results from the EFFISAYIL® 2 trial. Poster presented at 2025 AAD Annual Meeting; March 2025; Orlando. 2Gordon K, et al. Spesolimab improves quality of life as measured by Dermatology Life Quality Index (DLQI) in generalized pustular psoriasis (GPP) over time: Results from the EFFISAYIL® 2 trial. Poster presented at 2025 AAD Annual Meeting; March 2025; Orlando. 3Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19. 4Strober B, et al. Dermatol Ther. (Heidelb) 2021;11:529–41. 5Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256–273. 6Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71. 7Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919. Media Contact Jennifer Huron Boehringer Ingelheim Pharmaceuticals, Inc. Phone: +1 203-448-1263 Email: [email protected] SOURCE Boehringer Ingelheim WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2

31 Jul 2024

·pmlive.com

Boehringer Ingelheim’s Spevigo recommended by CHMP for generalised pustular psoriasis

Boehringer Ingelheim’s Spevigo (spesolimab) injection has been recommended by the European Medicines Agency’s committee for human medicines as a new indication for the prevention of generalised pustular psoriasis (GPP). The injection has been recommended to prevent GPP flares in adults and adolescents from 12 years of age, as well as the extension approval of Spevigo infusion to treat GPP flares in adults and adolescents from 12 years of age as a monotherapy. Recognised as a separate clinical entity from other forms of psoriasis, GPP is a chronic, heterogeneous, neutrophilic inflammatory disease that is associated with skin and systemic symptoms distinct from plaque psoriasis and can sometimes lead to multiple complications, including multisystem organ failure and sepsis. Already approved in 51 countries, including the EU , US and China, Spevigo is a novel, humanised selective IgG1 antibody that binds to the interleukin-36 receptor, a key part of a signalling pathway within the immune system shown to be associated with GPP. The Committee for Medicinal Products for Human Use’s decision was based on positive results from the 48-week phase 2b EFFISAYIL 2 clinical trial, as part of the EFFISAYIL clinical programme combining EFFISAYIL 1, a phase 2 study, EFFISAYIL ON, an open-label extension study and the ongoing EFFISAYIL REP open-label, phase 3b/4 trial. Results from the phase 2b trial showed that Spevigo significantly reduced the risk of GPP flares by 84% in 123 patients compared with placebo and no flare-ups were observed in patients from the high-dose group with Spevigo subcutaneous treatment after week four. In addition, the trial showed a consistent incidence of patients with adverse events across the Spevigo and placebo treatment arms. Commenting on the recommendation, Carinne Brouillon, head of human pharma at Boehringer, said: “The CHMP’s positive opinion on Spevigo… signals a strong shift in treatment, offering people living with [GPP] the potential for significant improvement of their condition and a better quality of life.” The company recently announced its acquisition of Nerio Therapeutics for up to $1.3bn, expanding its immune-oncology pipeline by gaining access to its small molecules designed to inhibit the protein tyrosine phosphatases N1 and N2.

Clinical ResultDrug ApprovalAcquisitionPhase 2Immunotherapy

29 Jul 2024

·www.globenewswire.com

CHMP adopts positive opinion recommending approval of new and expanded indications for SPEVIGO®

The CHMP positive opinion is based on the EFFISAYIL® 2 trial, which showed that no flares were observed after week 4 of SPEVIGO® administered subcutaneously. During the 48-week trial, an 84% reduction of the risk of GPP flares was observed.GPP is a rare, chronic, heterogenous neutrophilic inflammatory disease associated with skin flares and systemic symptoms, such as fever, pain, and fatigue.SPEVIGO® is currently approved in 51 countries for treatment of GPP flares, and the CHMP opinion follows similar approvals for expanded and new indications in the US and China. Boehringer Ingelheim today announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of a new indication of SPEVIGO® (spesolimab) injection for the prevention of generalized pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age; and extension of the approved indication for SPEVIGO® (spesolimab) infusion for the treatment of generalized pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age as monotherapy. SPEVIGO® is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP. The regulatory authorities’ decisions are based on the positive results of the EFFISAYIL® 2 trial, a 48-week clinical trial that showed that SPEVIGO® significantly reduced the risk of GPP flares by 84%, compared with placebo. In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30). The EFFISAYIL® 2 trial showed a similar incidence of patients with adverse events across spesolimab and placebo treatment arms. “GPP presents a significant diagnostic challenge for healthcare professionals as it is a highly variable rare disease that is experienced differently by everyone who has it, and it has suffered from a historic lack of treatment options,” said Dr Peter van der Kerkhof, Professor and previous Chairman of the Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. “Spesolimab’s recent approvals, combined with the CHMP recommendation provides us with the potential for continuous treatment, addressing a significant unmet need.” Distinct from plaque psoriasis, GPP is a rare, chronic, heterogenous, inflammatory neutrophilic disease associated with painful skin manifestations and systemic symptoms, such as fever, pain, and fatigue. GPP varies widely between individuals living with the condition, with symptoms presenting both above and below the skin. Uncontrolled GPP may require emergency care and can lead to life-threatening complications, such as multi-organ failure and sepsis. GPP’s unpredictable nature can potentially have significant long-term impacts on quality of life for people living with it and leads to fear and anxiety over the disease course. “The CHMP’s positive opinion on SPEVIGO®, alongside approvals in China and the US, signals a strong shift in treatment, offering people living with the disease the potential for significant improvement of their condition and a better quality of life,” said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “The potential to prevent GPP flare-ups means a possibility to gain back control over how people affected by the disease live their lives.” "GPP goes way beyond the skin, it's a relentless and unpredictable disease that can impact every aspect of a person's life,” said Frida Dunger, Executive Director, IFPA (International Federation of Psoriasis Associations). “I want a world where every person with GPP is diagnosed quickly and receives the treatment they need, and this is their right. There is much more to do, but I believe with all stakeholders working together we are headed in the right direction.” About SPEVIGO®SPEVIGO® is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP. About generalized pustular psoriasis (GPP)GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment. Prevalence of GPP varies considerably across geographical regions, ranging from 1.76 to 124 patients per million persons. GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems. GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances. About the EFFISAYIL® clinical trial programThe EFFISAYIL® clinical trial program evaluated the largest and broadest population of GPP patients in trials of a therapy specifically targeting the IL-36 pathway for GPP. EFFISAYIL® 1: A Phase II study that demonstrated treatment with a single intravenous dose of spesolimab significantly improved signs and symptoms of GPP in patients experiencing a flare, including rapid pustular and skin clearance. These results supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets.EFFISAYIL® 2: A Phase IIb study that showed subcutaneous spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. In the trial with 123 patients, no flares were observed after week 4 of spesolimab SC treatment in the high-dose group (n=30). EFFISAYIL® ON: An open-label extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP who have completed previous spesolimab trials. EFFISAYIL® REP (ongoing): An open-label, single-arm, Phase IIIb/IV trial to evaluate the efficacy, safety, and the impact of immunogenicity in the treatment of patients with GPP presenting with a recurrent flare following their initial GPP flare treatment with spesolimab IV. About Boehringer IngelheimBoehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at https://www.boehringer-ingelheim.com/.

Clinical ResultDrug ApprovalPhase 2

100 Deals associated with Spesolimab

External Link

KEGG	Wiki	ATC	Drug Bank
D12066	-	-	DB15626

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pustular psoriasis	Japan	Nippon Boehringer Ingelheim Co., Ltd.	26 Sep 2022
Generalized Pustular Psoriasis	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	01 Sep 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pyoderma Gangrenosum	Phase 3	United States	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	United States	Boehringer Ingelheim International GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	China	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Japan	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Japan	Boehringer Ingelheim International GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Argentina	Boehringer Ingelheim International GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Argentina	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Australia	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Australia	Boehringer Ingelheim International GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Austria	Boehringer Ingelheim International GmbH	04 Feb 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04362254 (CTgov)	Phase 2	Crohn Disease	12	Spesolimab	pacckjlzth = nkvzdydzlj eoakynyhkl (zhcuylbifm, vphtuspcqi - sownzrhglr) View more	-	05 Nov 2024
NCT04762277 (CTgov)	Phase 2	Hidradenitis Suppurativa	52	Placebo matching spesolimab - solution for infusion (Placebo)	ztttbaoejj(zpdnlhexxa) = cfqehqrfia qpopuwiiyr (zjbutohayj, 11.1) View more	-	09 Oct 2024
				Spesolimab - solution for infusion (Spesolimab)	ztttbaoejj(zpdnlhexxa) = qqoykmzkgc qpopuwiiyr (zjbutohayj, 7.5) View more
NCT05239039 (CTgov)	Phase 3	Generalized Pustular Psoriasis	39	spesolimab (Spesolimab Single Dose Treatment)	xavvfmiwiz = jmipeepygl khciuvgxhn (slyiwlrjsu, ijusjkfhfl - pwmywzyqrt) View more	-	09 Oct 2024
				spesolimab (Spesolimab Double Dose Treatment)	xavvfmiwiz = vgzjjqajoe khciuvgxhn (slyiwlrjsu, ztduqsobqn - lchersxfhr) View more
NCT05200247 (CTgov)	Phase 3	Generalized Pustular Psoriasis	11	Spesolimab	buhomwmtqv = miplrcubhp wuvvutrmav (rnugqegjpp, fsopfmpiya - trvmkhjysj) View more	-	15 Aug 2024
NCT03648541 (CTgov)	Phase 2	Colitis, Ulcerative	79	Spesolimab (300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks)	tramfjormx = ofjgwolxcp vcibufrxfh (wyrvvtlhcu, ihqurbphfg - uuznnqldrg) View more	-	03 Jul 2024
				Spesolimab (1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks)	xqvhdtzpsu(lorgqfucys) = cmxmzbbpsl hfrtcihopa (bgmowwegbg, jsvlfpdlyr - tbwhhwiptn) View more
NCT04493424 (CTgov)	Phase 2	Pustular psoriasis	108	Spesolimab	qzhfeotrdd = ckapbssrod gzqbdfrmkf (dolqjcstsp, tcffifvvoa - qfshedeqyn) View more	-	20 Mar 2024
NCT03100903 (CTgov)	Phase 1	-	36	BI 655130 (BI 655130 High Dose SC)	vsequubanw(mtjxmwwutd) = bkvgeckqpg cugvhsvfls (qucnogdxuc, NA) View more	-	18 Mar 2024
				BI 655130 (BI 655130 High Dose IV)	vsequubanw(mtjxmwwutd) = yfitudruwr cugvhsvfls (qucnogdxuc, NA) View more
NCT02852824 (CTgov)	Phase 1	-	40	Placebo+BI 655130 (Placebo Matching to BI 655130 Multiple Dose (MD))	ozsknzyvvh = tzqgzitraf vrfsflzsqf (usxmfmzada, ygimaocolr - vfywlmkddm) View more	-	18 Mar 2024
				BI 655130 (3 Milligram/Kilogram (mg/kg)] BI 655130 MD)	ozsknzyvvh = jbdmquhedy vrfsflzsqf (usxmfmzada, kxkfdendhk - ngjobivizh) View more
NCT03617835 (CTgov)	Phase 1	-	48	R - Low dose of BI 655130 (R - Low Dose of BI 655130 Periumbilical)	mpnbvftkcv(tuvdisfmxa) = edfewkpcoz faypubvruk (wjqgsdcqnt, NA) View more	-	15 Mar 2024
				T1 - Low dose of BI 655130 (T1 - Low Dose of BI 655130 Periumbilical (Left and Right))	mpnbvftkcv(tuvdisfmxa) = zovwrjnmna faypubvruk (wjqgsdcqnt, NA) View more
NCT03123094 (CTgov)	Phase 1	-	32	Spesolimab (Spesolimab Low Dose Group (Intravenous))	dwjiqgjrju = iconelrbuo nicfgoheot (kwfevhynuw, gdxsgpeyyb - nttxystfod) View more	-	06 Mar 2024
				Spesolimab (Spesolimab Medium Dose Group (Intravenous))	dwjiqgjrju = tzloiyqgfm nicfgoheot (kwfevhynuw, fxcqszaazf - oncfwmqiqi) View more

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