A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants

In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab subcutaneously (SC), also known as under the skin.
In this study, researchers want to learn more about new ways of delivering litifilimab SC using either an autoinjector (AI) or an on-body injector (OBI):
Both devices are designed to deliver litifilimab in an automatic way, especially helping patients who may not be able to use their hands very well, or who may be afraid of needles. While the AI is handheld, the OBI device works by being placed on the skin and can help deliver the highest amount of litifilimab through a single injection. The main objective of this study is to learn how the body processes litifilimab after using the AI device or the OBI device, as compared to using the PFS method.
The main questions researchers want to answer are:
* What is the highest amount of litifilimab found in the blood after dosing? How much total litifilimab is found in the blood throughout the study? Researchers will also learn more about: Any medical problems the participants have during the study
* Any injection site pain or reactions the participants may have. Any skin reactions to the OBI device
* Any changes in the participants' overall health after receiving litifilimab.
This study will be done as follows:
* Participants will be screened to check if they can join the study. The screening period will be up to 4 weeks, after which selected participants will check into their study research center.
* Participants will be randomly assigned to be in Part 1 or Part 2 of the study:
* Part 1: Participants will receive SC injection(s) of litifilimab through either the AI device or through PFS.
* Part 2: Participants will receive SC injection(s) of litifilimab through the OBI device or through PFS.
* Participants will remain at their study research center for the first 8 days. After that, there will be a follow-up period for 17 weeks during which participants return to the center a total of 6 times.
Each participant will be in the study for about 22 weeks.

Start Date02 Jan 2025

Sponsor / Collaborator

Biogen, Inc.

CTR20234203

/ RecruitingPhase 3

一项在患有活动性亚急性皮肤型红斑狼疮和/或慢性皮肤型红斑狼疮（有或无全身表现）且抗疟药治疗反应不佳和/或不耐受的受试者中评价 BIIB059 疗效和安全性的 2 部分无缝设计（A 部分 [II 期]/B 部分 [III 期]）、随机、双盲、安慰剂对照、多中心临床研究 (AMETHYST)

[Translation] A 2-part seamless design (Part A [Phase II]/Part B [Phase III]), randomized, double-blind, placebo-controlled, multicenter clinical study (AMETHYST) to evaluate the efficacy and safety of BIIB059 in subjects with active subacute cutaneous lupus erythematosus and/or chronic cutaneous lupus erythematosus (with or without systemic manifestations) who have an inadequate response and/or intolerance to antimalarial therapy

本研究的总体目的是在患有活动性 SCLE 和/或 CCLE（有或无全身表现）且抗疟药治疗反应不佳和/或不耐受的受试者中评价 BIIB059 与安慰剂相比的疗效和安全性。

[Translation]

The overall objective of this study was to evaluate the efficacy and safety of BIIB059 compared with placebo in subjects with active SCLE and/or CCLE (with or without systemic manifestations) who had an inadequate response to and/or intolerance to antimalarial therapy.

Start Date26 Jun 2024

Sponsor / Collaborator

Biogen Idec Research Ltd.

[+2]

CTR20231573

/ RecruitingPhase 3

一项在活动性系统性红斑狼疮成年受试者中评价 Litifilimab (BIIB059) 持续安全性和有效性的多中心，随机，剂量设盲的III期长程扩展研究

[Translation] A multicenter, randomized, dose-blinded, phase III long-term extension study to evaluate the sustained safety and efficacy of Litifilimab (BIIB059) in adult subjects with active systemic lupus erythematosus

本研究为一项多中心、随机、平行组、剂量设盲、III 期 LTE 研究。将在已完成研究 230LE303 或研究 230LE304（在本研究方案中称为“III 期母研究”）的持续 52 周研究治疗的受试者中开展本研究。

[Translation]

This study is a multicenter, randomized, parallel-group, dose-blinded, Phase III LTE study that will be conducted in subjects who have completed 52 weeks of study treatment in Study 230LE303 or Study 230LE304 (referred to as the “Phase III Parent Study” in this study protocol).

Start Date22 Apr 2024

Sponsor / Collaborator

Biogen Idec Research Ltd.

[+2]

100 Clinical Results associated with Litifilimab

100 Translational Medicine associated with Litifilimab

100 Patents (Medical) associated with Litifilimab

Literatures (Medical) associated with Litifilimab

01 Feb 2025·AUTOIMMUNITY REVIEWS

Deucravacitinib shows superior efficacy and safety in cutaneous lupus erythematosus compared to various biologics and small molecules – A systematic review and meta-analysis

Review

Author: Meznerics, Fanni Adél ; Galajda, Noémi Ágnes ; Lőrincz, Kende ; Szabó, Bence ; Bánvölgyi, András ; Hegyi, Péter ; Hidvégi, Bernadett ; Bokor, Laura Anna ; Kiss, Norbert ; Martyin, Katalin ; Krebs, Máté

BACKGROUND:

Novel therapies for cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) demonstrated efficacy and safety in previous trials. However, data on the comparison of these treatments is still lacking, limiting their integration into clinical practice. Therefore, our aim is to perform a systematic review and network meta-analysis to compare the efficacy and safety of novel systemic therapies in CLE.

METHODS:

A systematic search was performed across PubMed, Embase, and CENTRAL on November 25, 2023, to identify studies involving patients with CLE or SLE with active skin involvement treated with novel systemic therapies. The primary outcomes assessed were the proportion of patients achieving the Cutaneous Lupus Erythematosus Disease Area and Severity Index-50 (CLASI-50), the change in CLASI-A, the occurrence of adverse events (AEs), and serious adverse events (SAEs).

RESULTS:

18,280 records were retrieved, of which 53 met the inclusion criteria. Deucravacitinib showed significantly greater efficacy in achieving the CLASI50 compared to placebo (OR: 8.28, 95 % CI: 2.22-30.91). Both litifilimab (OR: 2.54, 95 % CI: 1.20-5.40) and anifrolumab (OR: 2.25, 95 % CI: 1.23-4.14) were also significantly more effective than placebo. No significant differences were observed in the occurrence of AEs and SAEs between these therapeutics and placebo.

CONCLUSION:

Anifrolumab and litifilimab are effective and safe treatment options in CLE. However, deucravacitinib demonstrated superior efficacy and safety with fewer adverse events compared to anifrolumab. CLE patients who have shown an inadequate response to first- and second-line treatments may benefit from the incorporation of deucravacitinib into their treatment regimens.

03 Dec 2024·Cureus Journal of Medical Science

Evolving Treatment Strategies for Systemic Lupus Erythematosus in Clinical Practice: A Narrative Review

Review

Author: Upshaw, William C ; Varrassi, Giustino ; Burroughs, Caroline R ; Mosieri, Chizoba N ; Tassin, Joseph P ; Patel, Chandni R ; Kaye, Alan D ; Bembenick, Kristin Nicole ; Shekoohi, Sahar ; Kaye, Adam M ; Hawkins, Alison M ; Ahmadzadeh, Shahab

Systemic lupus erythematosus (SLE) is an autoimmune disease that more commonly affects African American people, although it is seen in people of all racial backgrounds. This condition is characterized by a dysregulated immune response resulting in widespread inflammation. Clinical manifestations caused by this inflammation include arthritis, anemia, cutaneous rashes, pleuritis, and nephritis. Treatment for SLE aims to reduce disease activity and maintain a state of low inflammation. In this regard, numerous treatments are used, such as hydroxychloroquine, glucocorticoids, and non-glucocorticoid immunosuppressants such as methotrexate. Related to these drugs resulting in significant adverse effects and being ineffective in controlling SLE symptoms in some patients, new biologic agents have been created in hopes of better treating SLE. This includes belimumab and anifrolumab, monoclonal antibodies directed against the cytokine, and type 1 interferon receptor, respectively. These agents are indicated in patients with SLE whose symptoms are inadequately controlled by standard therapy alone. Clinical trials have shown that these agents effectively reduce SLE symptoms as judged using standardized metrics of disease activity. These biological agents have also been shown to have generally mild side effects when taken by patients with SLE, making them safe for use. In addition to the above medications, new treatments are being developed for SLE patients, such as cenerimod, litifilimab, chimeric antigen receptor T cells, and DS-7011a (anti-toll-like receptor 7 monoclonal antibody). These new treatments have shown promise in clinical trials. However, more information regarding their safety and efficacy is needed before they are available for the treatment of SLE.

01 Jul 2024·The Journal of dermatology

An update on clinical trials for cutaneous lupus erythematosus

Review

Author: Stone, Caroline J. ; Faden, Daniella Forman ; Xie, Lillian ; Lopes Almeida Gomes, Lais ; Werth, Victoria P.

Abstract:

Cutaneous lupus erythematosus (CLE) comprises dermatologic manifestations that may occur independently or with systemic lupus erythematosus (SLE). Despite advancements in refining CLE classification, establishing precise subtype criteria remains challenging due to overlapping presentations and difficulty in distinguishing morphology. Current treatments encompass preventive measures, topical therapies, and systemic approaches. Hydroxychloroquine and glucocorticoids are the sole US Food and Drug Administration (FDA)‐approved medications for CLE, with numerous off‐label treatments available. However, these treatments are often not covered by insurance, imposing a significant financial burden on patients. The exclusion of most CLE patients, particularly those without concurrent SLE, from trials designed for SLE has resulted in a lack of targeted treatments for CLE. To develop effective CLE treatments, validated outcome measures for tracking patient responsiveness are essential. The Cutaneous Lupus Erythematosus Disease Area and Severity Index is widely utilized for its reliability, validity, and ability to differentiate between skin activity and damage. In contrast, the FDA mandates the use of the Investigator's Global Assessment, a five‐point Likert scale related to lesion characteristics, for skin‐related therapeutic trials. It requires the disease to resolve or almost completely resolve to demonstrate improvement, which can be difficult when there is residual erythema or incomplete clearance that is meaningfully improved from a patient perspective. Various classes of skin lupus medications target diverse pathways, allowing tailored treatment based on the patient's lupus inflammatory profile, resulting in improved outcomes. Promising targeted therapeutic drugs include anifrolumab (anti‐type 1 interferon), deucravacitinib (allosteric tyrosine kinase 2 inhibitor), litifilimab (plasmacytoid dendritic cell‐directed therapy), iberdomide (cereblon‐targeting ligand), and belimumab (B‐cell directed therapy). Despite the significant impact of CLE on quality of life, therapeutic options remain inadequate. While promising treatments for cutaneous lupus are emerging, it is crucial to underscore the urgency for skin‐focused treatment outcomes and the implementation of validated measures to assess therapeutic effectiveness in clinical trials.

News (Medical) associated with Litifilimab

13 Feb 2025

·www.pharmaceutical-technology.com

Royalty Pharma pays $250m for rights to Biogen’s lupus drug

Payments to Biogen will be spread over six quarters. Credit: PeopleImages via Getty Images. Royalty Pharma has signed a deal to pay Biogen $250m to support the development of its late-stage experimental lupus medication litifilimab. In return, Royalty Pharma will receive undisclosed milestone payments if the drug meets certain regulatory goals, as well as mid-single-digit royalties on worldwide sales. Payments up to $250m to Biogen will be spread over six quarters, Royalty said in the announcement. Litifilimab, an anti-BDCA2 antibody, is being evaluated in Phase III trials for both systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Biogen will use the funds to continue development, with trial results expected in 2026 and 2027. The market for SLE remains largely dominated by generic drugs, with few targeted biologics approved by the US Food and Drug Administration (FDA) in the last 50 years . These include GSK’s Benlysta (belimumab) and AstraZeneca’s Saphnelo (anifrolumab). The market for CLE, however, has seen even less innovation. CLE is a form of lupus that primarily affects the skin, leading to inflammation, rashes, and lesions, though it can sometimes be linked to SLE. Litifilimab showed promising results in the Phase II LILAC study (NCT02847598), where it significantly reduced skin disease activity in people with CLE compared to placebo as measured by the primary endpoint. If approved, the drug could generate up to $750m in global sales by 2030, according to GlobalData’s Pharma Intelligence Center. GlobalData is the parent company of Pharmaceutical Technology. This agreement expands Royalty’s portfolio, adding to a series of deals that the company has struck over recent years. This includes transactions with BridgeBio Pharma, ImmuNext, Cytokinetics and Agios Pharmaceuticals. Royalty’s deal with ImmuNext provided it with access to royalties and milestones on a drug to treat multiple sclerosis (MS) under development with Sanofi. Royalty also holds rights on Biogen’s MS medication Tysabri (natalizumab) and spinal muscular atrophy drug Spinraza (nusinersen), acquired through agreements with Ionis and Perrigo. The deal coincides with Biogen’s latest earnings report, in which the company exceeded Q4 2024 expectations due to cost-cutting measures and new product launches, including its Alzheimer’s drug Leqembi (lecanemab). However, Biogen expects reduced profits this year, citing currency fluctuations and competition in the MS market. The biotech also announced the discontinuation of four drug development programmes: a Phase II asset for diabetic peripheral neuropathic pain and three Phase I neurodegenerative disease candidates. Biogen hit the headlines last month when Sage Therapeutics rejected its $469m takeover offer, with the company’s board of directors unanimously concluding that the bid “significantly undervalues” the company. Made earlier this year, the proposal offered $7.22 per share, a 30% premium on Sage’s share price at the time. Sage responded by suing Biogen to “enforce a standstill agreement” between the two companies. Biogen currently co-markets Sage’s postpartum depression drug Zurzuvae (zuranolone).

Phase 2Phase 3Clinical ResultDrug ApprovalAcquisition

12 Feb 2025

·www.fiercebiotech.com

Biogen enlists Royalty for pursuit of lupus crown, securing $250M to fund phase 3 program

With litifilimab, Biogen is going after the type 1 interferon signature by inhibiting BDCA2.\n Biogen has bagged $250 million to advance a key pipeline prospect. Royalty Pharma is providing the cash to bankroll phase 3 development of a lupus candidate that Biogen has named in a bunch of assets with potential peak sales of $14 billion.The candidate, the anti-BDCA2 antibody litifilimab, is in phase 3 development in systemic and cutaneous lupus erythematosus (SLE/CLE). There is unmet need in both diseases. SLE patients have limited choices, with GSK’s Benlysta and AstraZeneca’s Saphnelo the only options, but that is rich pickings compared to CLE. Physicians have been waiting decades for an advance in the treatment of the cutaneous disease.Biogen believes litifilimab can address the unmet needs. But, with a pipeline of other programs—including two other lupus assets—to develop, the biotech has opted to seek external money to fund phase 3 trials in SLE and CLE.Royalty is providing the money, agreeing to drip-feed Biogen $250 million over six quarters in exchange for regulatory milestones and mid-single-digit royalties on annual worldwide sales. Royalty, a buyer of biopharmaceutical royalties, already receives a cut of the sales of Biogen’s Tysabri and Spinraza. The firm secured those royalties through deals with Ionis and Perrigo rather than directly from Biogen. Biogen has prioritized its pipeline under CEO Christopher Viehbacher, helping it cut R&D spending by 17% last year. The Royalty deal supports ongoing cost management while still allowing Biogen to attempt to bring litifilimab to market.Viehbacher talked up litifilimab’s prospects on an earnings call in October, including the asset among a clutch of candidates that the CEO said could collectively generate peak sales of $9 billion to $14 billion. CLE is an untapped opportunity. Litifilimab will face competition if it comes to market in SLE, potentially from Biogen’s own dapirolizumab, but Viehbacher sees room for multiple molecules.“This is a complex disease that affects different organs at a time,” Viehbacher said at the J.P. Morgan Healthcare Conference last month. “I think it\'s going to be a little like MS. You\'re really going to decide which product is best at which point in time for every patient. And so I don\'t think this is one product for the whole disease.”Dapirolizumab inhibits the CD40 ligand to reduce activation of B and T cells and downregulate interferon. With litifilimab, Biogen is going after the type 1 interferon signature by inhibiting BDCA2 in the plasma delta. The biotech is aiming to file for approval of litifilimab in SLE and CLE from 2027 to 2029.

Phase 3

12 Feb 2025

·endpts.com

Biogen gets $250M in Royalty Pharma deal for Phase 3 lupus program

Biogen is turning to Royalty Pharma for some cash in exchange for rights to a lupus program, the companies announced Wednesday. The two have agreed on a deal for litifilimab, an anti-BDCA2 drug currently in Phase 3 trials for two kinds of lupus. Biogen will get $250 million in cash, which it will use to continue developing the program, while Royalty Pharma may get undisclosed payments based on regulatory milestones, as well as royalty payments in the mid-single digits. The announcement coincided with Biogen’s fourth-quarter earnings, in which Biogen beat Wall Street expectations for earnings per share, as well as sales of the Alzheimer’s drug Leqembi. Biogen investors have begun growing restless , as the company looks for ways to create long-term growth. CEO Chris Viehbacher and other executives have previously said the company has between $5 billion and $10 billion to make an acquisition before the end of the year. During last quarter’s call with analysts, Viehbacher faced questions about Biogen’s lupus efforts, with some wondering why the company wasn’t focusing on bringing CAR-T to lupus like many other biopharmas. In addition to litifilimab, Biogen also has an anti-CD40 program in Phase 3 testing for lupus called dapirolizumab pegol, which succeeded in one Phase 3 study last year and has a second trial that has launched. Biogen also noted that it’s completed $400 million in net savings of its cost-cutting program announced in mid-2023. The goal of $1 billion in gross savings is still on track to wrap up by the end of 2025. (Last month’s research reorganization is not part of these cuts.) In addition, Biogen announced that it is trimming four programs from its early-stage pipeline: BIIB113, an oral inhibitor of tau aggregation for Alzheimer’s disease; BIIB094, an antisense oligonucleotide targeting LRRK2 for Parkinson’s disease; BIIB101, an Ionis-partnered antisense drug for multiple system atrophy; and BIIB143/cemdomespib, a drug from Reata in diabetic neuropathic pain.

OligonucleotidePhase 3

100 Deals associated with Litifilimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Erythematosus, Cutaneous	Phase 3	United States	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Argentina	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Brazil	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Bulgaria	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Canada	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Chile	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	France	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Germany	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Hungary	Biogen, Inc.	03 Oct 2023
Lupus Erythematosus, Cutaneous	Phase 3	Italy	Biogen, Inc.	03 Oct 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02847598 (LILAC \| LILAC study, CTgov)	Phase 2	Lupus Erythematosus, Cutaneous \| Systemic Lupus Erythematosus	264	Placebo (Part A: Placebo)	mraxlrxrqd(mylmyjushl) = bdgrjrmtab ptoelooowy (xvqqiuzxbc, 10.3) View more	-	15 May 2023
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	mraxlrxrqd(mylmyjushl) = pgklqazcem ptoelooowy (xvqqiuzxbc, 8.7) View more
NCT02847598 (LILAC, Pubmed \| N Engl J Med)	Phase 2	Systemic Lupus Erythematosus BDCA2	132	Litifilimab 450 mg	tueogkxvpk(lnaevbayxa): P-Value = 0.04 View more	Positive	08 Sep 2022
				Placebo
NCT02847598 (LILAC study, EULAR2022)	Phase 2	Lupus Erythematosus, Cutaneous BDCA2	-	BIIB059	ujzkhimugg(laifamnfwj) = vphubminha jkyoexvwxf (dztvixwyvs ) View more	Positive	01 Jun 2022
NCT02847598 (LILAC, EULAR2022)	Phase 2	Systemic Lupus Erythematosus anti-nuclear antibodies \| anti-double-stranded DNA antibodies	-	BIIB059 450 mg	pazyxufuvw(dkohbzbosw) = bmzbaahylz rhswbvuzxh (twtfubfvfo ) View more	Positive	01 Jun 2022
				Placebo	pazyxufuvw(dkohbzbosw) = sqeijwurgb rhswbvuzxh (twtfubfvfo ) View more
NCT02847598 (LILAC, ACR2020) Manual	Phase 2	Systemic Lupus Erythematosus	120	BIIB059	prnxymbvor(fjtkanrdbq) = obulilsici vhdovtycls (dswyjgkmcj, 1.2) View more	Positive	07 Nov 2020
				Placebo	prnxymbvor(fjtkanrdbq) = ffpxegqygq vhdovtycls (dswyjgkmcj, 1.3) View more
NCT02847598 (LILAC, EULAR2020)	Phase 2	Lupus Erythematosus, Cutaneous	132	BIIB059 50 mg	omxfxtewam(bxkktcofzd) = 62 (62.6%) 80 (60.6%) awgbbygkyt (wkpfxetwlz ) View more	Positive	03 Jun 2020
				BIIB059 150 mg
NCT02847598 (Pubmed \| J Pharmacokinet Pharmacodyn)	Phase 2	Lupus Erythematosus, Cutaneous	264	BIIB059	hywddpmass(npusztunox) = kqvqfquvvb cipgmdfdyq (lddavrgqrs ) View more	-	01 Jun 2020
NCT02106897 (Pubmed \| J Clin Invest) Manual	Phase 1	Eczema \| Systemic Lupus Erythematosus	54	BIIB059	mkgwhbqzud(eytagufckv) = cprkdbuefp sjvvmqyyda (sibsahxjwa ) View more	Positive	01 Mar 2019
				Placebo	mkgwhbqzud(eytagufckv) = chzpovnfrh sjvvmqyyda (sibsahxjwa ) View more
NCT02106897 (EULAR2018)	Phase 1	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	lnznrtplfz(ryqhhpgkhi) = eqrsopqocx uuobbwfrfl (pztjvzytcm ) View more	-	13 Jun 2018
				BIIB059 20, 50 or 150 mg SC	bbbbwchgse(zdbodsupeq) = cdihrzjybx vouyunqooc (sbxdvfbwwb ) View more
EULAR2017	Not Applicable	BDCA2	54	BIIB059	hduhwevviv(mxnhwbzwid) = All AEs were mild to moderate in severity with no serious AEs ugruaibetn (cclddznttr ) View more	-	14 Jun 2017

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