A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

Study Purpose

The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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. Active severe lupus nephritis. 3. Active neuropsychiatric SLE. 4. Use of intralesional corticosteroids within 1 week prior to Screening and during the study. 5. 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 randomization, have not been at a stable and allowable dose. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05531565
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Biogen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Director
Principal Investigator Affiliation	Biogen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

Additional Details

BIIB059 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2 and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus.

Arms & Interventions

Arms

Experimental: Part A (Phase 2): BIIB059

Participants will receive BIIB059 subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.

Placebo Comparator: Part A (Phase 2): Placebo

Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.

Experimental: Part B (Phase 3): BIIB059

Participants will receive BIIB059 SC Q4W from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.

Placebo Comparator: Part B (Phase 3): Placebo

Interventions

Drug: - BIIB059 (litifilimab)

Administered as specified in the treatment arm.

Drug: - Placebo

Administered as specified in the treatment arm.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pinnacle Research Group, LLC, Anniston, Alabama

Status

Recruiting

Address

Pinnacle Research Group, LLC

Anniston, Alabama, 36207

Site Contact

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