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 (AMETHYST)

Biogen

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Subacute Cutaneous Lupus Erythematosus; Chronic Cutaneous Lupus Erythematosus

Treatments: Drug: BIIB059 (litifilimab); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05531565

2020-000727-40 (EudraCT Number)

230LE301

Details and patient eligibility

About

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].

Full description

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.

Enrollment: 474 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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474 participants in 4 patient groups, including a placebo group

Part A (Phase 2): BIIB059

Experimental group

Description:

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.

Treatment:

Drug: BIIB059 (litifilimab)

Part A (Phase 2): Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Part B (Phase 3): BIIB059

Experimental group

Description:

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.

Treatment:

Drug: BIIB059 (litifilimab)

Part B (Phase 3): Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo