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Phase 2

Phase 3

LitifilimabA 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Sponsor:

Biogen

Code:

NCT05531565

Conditions

Subacute Cutaneous Lupus Erythematosus

Chronic Cutaneous Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Litifilimab

Placebo

Study Details

Brief summary:

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).

The main questions researchers want to answer are:

How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?
How many participants have their skin disease activity go down by at least 70% as measured by CLASI?

Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.

The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:

After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.
Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.
The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.
During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.
After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.
The total study duration for participants will be up to 80 weeks.

Conditions

Subacute Cutaneous Lupus Erythematosus

Chronic Cutaneous Lupus Erythematosus

Study ID

NCT05531565

Start date

Sep 13, 2022

Status verified date

Jun, 2026

Completion date

Dec 14, 2027

Anticipated

Primary completion date

Oct 20, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
2. Must have active cutaneous manifestations that meet study criteria.
3. Must have a CLASI-A score ≥10.
4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Key Exclusion Criteria:

1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
2. Diagnosis of mixed connective tissue disease \[(within 1 year of signing the informed consent form (ICF)\] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
3. Active severe lupus nephritis.
4. Active neuropsychiatric SLE.
5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE \[via an oral, intravenous (IV), or SC route\] that were initiated less than 12 weeks prior to screening, have not been at a stable and allowable dose.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A (Phase 2): Litifilimab

Participants will receive litifilimab subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive litifilimab during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.

placebo comparator: Part A (Phase 2): Placebo

Participants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.

experimental: Part B (Phase 3): Litifilimab

Participants will receive litifilimab SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.

placebo comparator: Part B (Phase 3): Placebo

Interventions

Litifilimab

Administered as specified in the treatment arm.

Placebo

Administered as specified in the treatment arm.

Primary outcome measure

Parts A: Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 [ Time Frame: Week 16 ]
Part B: Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline [ Time Frame: Baseline to Week 24 ]

Central Contacts and Locations

More Information

Sponsor

Biogen

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

Cutaneous Lupus Erythematosus (CLE)
Discoid Lupus Erythematosus (DLE)
Systemic Lupus Erythematosus (SLE)
Lupus
Subacute Cutaneous Lupus Erythematosus (SCLE)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Biogen on 2026-06-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.