A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Start Date14 Apr 2022

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

ACTRN12617000369325

/ CompletedPhase 1

A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANB019 in Healthy Subjects and Psoriasis Patients.

Start Date03 Apr 2017

Sponsor / Collaborator

AnaptysBio Pty Ltd.

[+1]

100 Clinical Results associated with Imsidolimab

100 Translational Medicine associated with Imsidolimab

100 Patents (Medical) associated with Imsidolimab

Literatures (Medical) associated with Imsidolimab

01 May 2024·American journal of clinical dermatology

Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis

Review

Author: Wu, Po-Chien ; Huang, Yu-Huei ; Huang, I-Hsin ; Chiu, Hsien-Yi

BACKGROUND:

The comparative efficacy of biologics and small-molecule inhibitors in treating palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP) remains uncertain.

OBJECTIVE:

The aim was to perform a systematic review and network meta-analysis (NMA) to compare the efficacy of biologics and small-molecule inhibitors for the treatment of PP and PPP.

METHODS:

MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched for eligible studies from inception to May 13, 2023. This NMA was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension Statement for Network Meta-Analyses guidelines. Frequentist random-effects models NMA was performed with the surface under the cumulative ranking curve calculated for ranking. Our primary outcome was the proportion of patients achieving a clear/minimal Palmoplantar Psoriasis/Pustulosis Physician Global Assessment score (PPPGA 0/1 or PPPPGA 0/1) response at 12-16 weeks. Secondary outcomes consisted of the percentage of overall improvement in palmoplantar score and of improvement ≥ 75%, at 12-16 weeks.

RESULTS:

The study comprised a total of 29 randomized controlled trials (RCTs), involving 4798 psoriasis patients with palmoplantar diseases. For PP, 16 RCTs with nine different treatments, including adalimumab, apremilast, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab were included for the analysis. In the NMA of PP, secukinumab 300 mg ranked highest (odds ratio [OR] 33.50, 95% confidence interval [CI] 4.37-256.86) in achieving PPPGA 0/1, followed by guselkumab 100 mg (OR 18.68, 95% CI 10.07-34.65). In the case of PPP, seven RCTs with six treatments, including apremilast, etanercept, guselkumab, imsidolimab, spesolimab, and ustekinumab, were included for the analysis. In the NMA of PPP, although no treatment demonstrated a significant difference compared to placebo in achieving PPPPGA 0/1, guselkumab 100 mg showed the greatest statistically significant improvement in the palmoplantar score (weighted mean difference 31.73, 95% CI 19.89-43.57) as a secondary outcome.

CONCLUSION:

Among all available biologics and small-molecule inhibitors, secukinumab 300 mg and guselkumab 100 mg had the most favorable efficacy in treating PP and PPP, respectively.

17 Jul 2023·The British journal of dermatology

Imsidolimab: an emerging biological therapy for generalized pustular psoriasis.

Communications

Author: Gleeson, David ; Mahil, Satveer K

17 Jul 2023·The British journal of dermatology

Imsidolimab, an anti-interleukin-36 receptor monoclonal antibody, for the treatment of generalized pustular psoriasis: results from the phase II GALLOP trial

Article

Author: Placek, Waldemar ; Zhou, Jihao ; Reich, Adam ; Kaszuba, Andrzej ; Warren, Richard B ; Gudjonsson, Johann E ; Griffiths, Christopher E M ; Randazzo, Bruce ; Lizzul, Paul

Abstract:

Background:

Generalized pustular psoriasis (GPP) is a systemic inflammatory disease that can be severe, debilitating and life threatening. Uncontrolled activation of interleukin (IL)-36 proinflammatory activity may underlie the pathogenesis of GPP. Currently, GPP-specific treatment options are limited.

Objectives:

To evaluate the efficacy and safety of the anti-IL-36 receptor antibody imsidolimab in patients with GPP.

Methods:

In an open-label, single-arm, multiple-dose study, patients with GPP were treated with imsidolimab to assess clinical efficacy, tolerability and safety. Patients received an intravenous dose of imsidolimab 750 mg on day 1, followed by three subcutaneous doses of imsidolimab 100 mg administered on days 29, 57 and 85. The primary efficacy endpoint was the proportion of patients who achieved a clinical response at weeks 4 and 16 following treatment with imsidolimab, as measured by the Clinical Global Impression scale.

Results:

Eight patients were enrolled and six completed the study. Responses were observed as early as day 3, most rapidly for pustulation relative to other manifestations of GPP, with continued and consistent improvement across multiple efficacy assessments at day 8, day 29 and through day 113. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. No patient discontinued the study owing to a nonserious TEAE. Two patients experienced serious adverse events (SAEs); no deaths were reported.

Conclusions:

Imsidolimab demonstrated a rapid and sustained resolution of symptoms and pustular eruptions in patients with GPP. It was generally well tolerated, with an acceptable safety profile, and is advancing to phase III trials. These data support the targeting of IL-36 signalling with a specific antibody – imsidolimab – as a therapeutic option for this severely debilitating condition.

News (Medical) associated with Imsidolimab

01 Oct 2025

·www.biospace.com

AnaptysBio Plans Business Split To Sharpen Focus on Asset Value

iStock, SvetaZi The business separation, expected to be completed by the end of 2026, will result in two new companies, one focused on biopharma operations and the other on royalty management. AnaptysBio will split its current business into two publicly traded entities: one focused on biopharma operations, including advancing the original company’s clinical pipeline, and the other on royalty management. The business separation, according to analysts at Leerink Partners, will help AnaptysBio crystallize the value of its royalties and highlight the worth of its other assets. “We believe this separation will sharpen investor focus on the company’s asset values by distinguishing between a royalty-backed cash flow vehicle and a clinical-stage pipeline company,” the analysts wrote in an investor note on Tuesday. After the split, much of the work of the royalty-focused company will revolve around Jemperli , GSK’s PD-1 blocker indicated for endometrial cancer and solid tumors. Jemperli was discovered by AnaptysBio, which licensed it out to TESARO in March 2014 under a worldwide immuno-oncology antibody partnership. GSK acquired TESARO in December 2018 for $5.1 billion . According to AnaptysBio’s Tuesday release, GSK has maintained a guidance of around $2.7 billion in peak Jemperli sales and has continued to assess the drug in other indications, including rectal cancer, colon cancer and head-and-neck squamous cell carcinoma. The royalty arrangement over Jemperli will extend “at least through expiration” of related patents, according to AnaptysBio’s statement. The royalty entity will also manage payments from Vanda Pharmaceuticals for the IL-36 receptor inhibitor imsidolimab, being developed for generalized pustular psoriasis under a February 2025 contract . This new royalty spinout will be eligible for $35 million in milestone payments plus a 10% royalty on net sales, according to AnaptysBio. Meanwhile, the resulting biopharma company will be dedicated to the development of its CD122 antagonist ANB033, being tested in a Phase Ib trial for celiac disease, and the BDCA2 modulator ANB101, which is currently being studied in healthy volunteers in a Phase Ia trial. At its launch, this new biopharma spinout will have enough money to keep it running for “at least two years,” the release stated. Leading this new entity’s pipeline is the T cell depleter rosnilimab, which in May this year cleared the Phase IIb RENOIR study in rheumatoid arthritis. The asset is currently in a Phase IIb trial of ulcerative colitis, with data expected by the end of the year. AnaptysBio is currently reviewing its strategic options for rosnilimab, the company said on Tuesday, the results of which will determine how the value of the asset will be allocated between the two companies. AnaptysBio has yet to disclose names for these two new entities, though current CEO Daniel Faga will lead the biopharma spinout. The company expects to complete this business split by the end of 2026.

Phase 2Phase 1AcquisitionDrug ApprovalLicense out/in

30 Sep 2025

·endpoints.news

AnaptysBio plans to split its pipeline from its royalty assets into two publicly traded companies

AnaptysBio wants to split into two companies to see if its pipeline and royalty assets will get more appreciation from investors if they stand alone. The San Diego biotech said Monday that it will start by exploring separating its business into two publicly traded companies. With three clinical-stage assets, including one on the verge of Phase 3, the company will need hefty funds to advance those experimental medicines. The company’s lead drug, a T cell depleter known as rosnilimab, is slated to have a Phase 2 readout in ulcerative colitis by the end of the year. AnaptysBio wants to find a global partner for the drug in UC, rheumatoid arthritis and other indications, though it can take the drug into Phase 3 in UC on its own. “Management was clear that the move was in no way a reflection on their confidence in the topline data readout of rosnilimab in UC,” TD Cowen analysts wrote in a Monday note. AnaptysBio’s pipeline also contains a CD122 antagonist called ANB033 that is in Phase 1b for celiac disease and is set to enter studies for inflammatory disease next year. A healthy volunteer trial is currently assessing the BDCA2 modulator known as ANB101 in inflammatory disease. Meanwhile, AnaptysBio wants to unlock the full value of its royalties at a time when the royalty business has picked up steam . The company receives royalties from GSK via their cancer drug Jemperli. AnaptysBio currently transfers the royalties from GSK to the royalty aggregator Sagard. Once Sagard gets $600 million from the royalty arrangement, AnaptysBio no longer has to fork over the royalties. The biotech anticipates that will happen between mid-2027 and the second quarter of 2028. GSK continues to test Jemperli in additional indications, meaning its sales could go up in the future and provide more royalties for AnaptysBio. The drug racked up £196 million (about $260 million) in revenue in the second quarter of this year. AnaptysBio also hopes to get milestone payments and royalties from Vanda regarding imsidolimab. The drug failed a trio of trials in 2021 and 2022 , leading to the AnaptysBio CEO’s resignation , but eventually cleared a Phase 3 in a rare form of psoriasis in 2023. The drug was transferred to Vanda, which is expected to submit an application to the FDA in the second half of this year. An approval in the US would trigger a $5 million milestone for AnaptysBio, up to another $30 million in milestones, and 10% royalty on sales.

Phase 3Phase 2Drug ApprovalPhase 1Accelerated Approval

07 May 2025

·www.prnewswire.com

Vanda Pharmaceuticals Reports First Quarter 2025 Financial Results

Fanapt® Q1 2025 total prescriptions (TRx) increased 14% compared to Q1 2024 Fanapt® Q1 2025 new to brand prescriptions (NBRx) increased nearly threefold compared to Q1 2024 Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026 Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON, May 7, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2025. Continue Reading Fanapt® TRx and NBRx "Vanda has entered a new growth phase with multiple commercialized products and a rich innovative pipeline. Fanapt commercial growth has accelerated, reaching multi-year highs, with weekly prescriptions surpassing 2,000 at the end of April as an increasing number of prescribers are adding Fanapt to their therapeutic armamentarium," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Our recent new drug application filings for tradipitant and Bysanti are a testament to our productive research and development pipeline. The addition of imsidolimab alongside Ponvory establishes an anti-inflammatory franchise that we believe has significant growth potential. These accomplishments have been possible because of our talented employees, who for the first time surpassed 400 in number, a 22-year high." Financial Highlights Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $50.0 million in the first quarter of 2025, a 5% increase compared to $47.5 million in the first quarter of 2024. Fanapt® net product sales were $23.5 million in the first quarter of 2025, a 14% increase compared to $20.6 million in the first quarter of 2024. HETLIOZ® net product sales were $20.9 million in the first quarter of 2025, a 4% increase compared to $20.1 million in the first quarter of 2024. PONVORY® net product sales were $5.6 million in the first quarter of 2025, a decrease of 18% compared to $6.8 million in the first quarter of 2024. Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. The net loss in the first quarter of 2025 reflects expenses associated with the payment of $15.0 million related to the exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab and increased commercial activities. Cash, cash equivalents and marketable securities (Cash) was $340.9 million as of March 31, 2025, representing a decrease to Cash of $33.7 million compared to December 31, 2024. The decrease to Cash reflects the payment of $15.0 million during the first quarter of 2025 related to the exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab. Key Operational Highlights – Commercial Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the first quarter of 2025, as compared to the first quarter of 2024, total prescriptions (TRx)1 increased by approximately 14% and Fanapt® net product sales increased by 14%. Additionally, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by nearly threefold in the same period. Fanapt® total prescriptions (TRx) for the week of April 25, 2025 reached the milestone of 2,000, making Fanapt® one of the fastest growing atypical antipsychotics.1 Vanda has also announced an expansion of its psychiatry sales force to approximately 300 representatives. HETLIOZ® (tasimelteon) Through the first quarter of 2025, HETLIOZ® continues to retain the largest portion of market share despite generic competition for over two years.2 PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. In April 2025, new patient prescriptions reached a new record high since the initiation of Vanda's commercial launch. Vanda has re-enforced the PONVORY® sales leadership team and announced an expansion of its PONVORY® sales force to approximately 40 representatives. Key Operational Highlights – Regulatory & Clinical Development Key Regulatory Milestones Tradipitant New Drug Application (NDA) for motion sickness accepted for filing by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. Fanapt® Marketing Authorization Application (MAA) for bipolar I disorder and schizophrenia submitted to the European Medicines Agency (EMA) in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted to the EMA in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025. Key Clinical Highlights Fanapt® (iloperidone) Schizophrenia: A Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the treatment of schizophrenia in relapse prevention is ongoing. Hypertension: Vanda initiated a study of the Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension and plans to begin enrolling patients soon. Bysanti™ (milsaperidone) The NDA for Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia was accepted for filing by the FDA with a PDUFA target action date of February 21, 2026. Exclusivity for Bysanti™, including pending patent applications, could extend into the 2040s. Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies. The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in Scottsdale, Arizona. The Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is ongoing. Results are expected in 2026. HETLIOZ® (tasimelteon) HETLIOZ® clinical programs in pediatric insomnia and delayed sleep phase disorder (DSPD) are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for SMS is pending with the EMA. PONVORY® (ponesimod) Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was accepted for filing by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide). Results are expected in the third quarter of 2025. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with Anaptys for the development and commercialization of imsidolimab (IL-36R antagonist mAb). A BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate the Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. GAAP Financial Results Net loss was $29.5 million in the first quarter of 2025 compared to net loss of $4.1 million in the first quarter of 2024. Diluted net loss per share was $0.50 in the first quarter of 2025 compared to diluted net loss per share of $0.07 in the first quarter of 2024. 2025 Financial Guidance Vanda is reiterating its 2025 total revenues guidance and updating its 2025 financial guidance to include year-end 2025 Cash. Vanda expects to achieve the following financial objectives in 2025: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 7, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2025 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 9941754. A replay of the call will be available on Wednesday, May 7, 2025, beginning at 8:30 PM ET and will be accessible until Wednesday, May 14, 2025 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 9941754. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Based on blended data analysis About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance" above and statements regarding the growth potential of Vanda's anti-inflammatory franchise; Vanda's plans for pursuit of FDA approval of Bysanti™ for the acute treatment of bipolar I disorder and the treatment of schizophrenia, tradipitant for the treatment of motion sickness, and imsidolimab for the treatment of GPP, and the related timelines; Vanda's plans for pursuit of EMA approval of Fanapt® for the treatment of bipolar I disorder and schizophrenia and HETLIOZ® and HETLIOZ LQ® for the treatment of SMS; Vanda's clinical development plans and expected timelines for Fanapt® LAI as a once-a-month injectable for uncontrolled hypertension, Bysanti™ for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the expected timing of the results of the tradipitant clinical trial for the prevention of vomiting induced by Wegovy; and the potential to extend patent exclusivity for Bysanti™ into the 2040s are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; Vanda's ability to obtain regulatory approval and execute a successful commercial launch of imsidolimab, and increase PONVORY® revenue; the FDA's ability to complete its reviews of, and reach decisions with respect to, the NDAs for Bysanti™ and tradipitant by their respective PDUFA target action dates; Vanda's ability to complete and submit the BLA for imsidolimab in 2025; Vanda's ability to obtain EMA approval of the MAAs for Fanapt® and HETLIOZ® and HETLIOZ LQ®, Vanda's ability to begin enrolling patients in the Fanapt® LAI study within the specified timeframe; Vanda's ability to complete the Phase III clinical study for Bysanti™ for MDD and receive results in 2026; Vanda's ability to complete the clinical trial of tradipitant for the prevention of vomiting induced by Wegovy and receive results in the third quarter of 2025; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; and Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 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Phase 1License out/inDrug ApprovalPhase 3NDA

100 Deals associated with Imsidolimab

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Indication	Highest Phase	Country/Location	Organization	Date
Generalized Pustular Psoriasis	Phase 3	China	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	China	Ppc China Corp. Ltd.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Australia	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Australia	Ppc China Corp. Ltd.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Malaysia	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Malaysia	Ppc China Corp. Ltd.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	South Korea	Ppc China Corp. Ltd.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	South Korea	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Taiwan Province	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Taiwan Province	Ppc China Corp. Ltd.	25 May 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05352893 (GEMINI1, GlobeNewswire) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab 750mg (GEMINI-1)	zlimtjksow(mohwzlbqqq) = xapmclxlsz wenbjcvtha (ktpyuutjur )	Positive	09 May 2024
				Imsidolimab 300mg (GEMINI-1)	zlimtjksow(mohwzlbqqq) = bvjvvqnxho wenbjcvtha (ktpyuutjur )
NCT05352893 (GEMINI1, Corporate Publications) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab	jpwuyzwbro(zqyticavpr) = mauxsftdyw chzfxgezuo (hbeeontnyz ) Met View more	Positive	09 Oct 2023
				Placebo	jpwuyzwbro(zqyticavpr) = xsytarmlxu chzfxgezuo (hbeeontnyz ) Met

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