A Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST) - AMETHYST

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000727-40-DE

Enrollment

474

Registered

2022-09-19

Start date

2023-05-19

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus MedDRA version: 21.1 Level: PT Classification code 10056509 Term: Cutaneous lupus erythematosus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: PT Classification code 10057903 Term: Subacute cutaneous lupus erythematosus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: PT Classification code 10057929 Term: Chronic cutan

Interventions

Product Name: litifilimab Product Code: BIIB059 Pharmaceutical Form: Solution for injection INN or Proposed INN: litifilimab CAS Number: 2407378-48-5 Current Sponsor code: BIIB059 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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. NOTE: Other protocol defined Inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 464 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 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 Exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of the study are to evaluate the efficacy of BIIB059 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.;Secondary Objective: 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].;Primary end point(s): Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 Part B (ROW): 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;Timepoint(s) of evaluation of this end point: Parts A (US+ROW) and B (US): Week 16 Part B (ROW): Baseline to Week 24	—

Measure

Time frame

Main Objective: The primary objectives of the study are to evaluate the efficacy of BIIB059 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.;Secondary Objective: 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].;Primary end point(s): *Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 * Part B (ROW): 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;Timepoint(s) of evaluation of this end point: Parts A (US+ROW) and B (US): Week 16 Part B (ROW): Baseline to Week 24

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Secondary

Measure	Time frame
Secondary end point(s): Parts A(US+ROW)&B(US): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1 Part B(ROW): % of Participants who Achieve CLASI-70 Response, Defined as = 70% Decrease in CLASI-A Score From Baseline Part A(US+ROW): % of Participants who Achieve a CLASI-50 Response, Defined as a = 50% Decrease in CLASI-A Score From Baseline Part A(US+ROW): Change From Baseline in CLASI-D Score Part B (US+ROW): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at W16&W24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score =3 and OMC Score =3 at Baseline Part B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at W16&W24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score =3 and OMC Score =3 at Baseline Part B(US+ROW): % of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score Part B(US+ROW): Absolute Change in CLASI-D Score Part B(US+ROW): Percent Change in CLASI-D Score Part B(US+ROW): Change From Baseline in CLE-QoL Score Part B(US+ROW): Change From Baseline in DLQI Score Parts A(US+ROW)&B(US): % of Participants who Achieve a CLASI-70 Response, Defined as a = 70% Decrease in CLASI-A Score From Baseline Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1 Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0 Parts A&B(US+ROW): % of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0 Parts A&B(US+ROW): % of Participants who Achieve a CLASI-A Score of 0 or 1 Parts A&B(US+ROW): % of Participants who Achieve a CLASI-A Score of 0 or 1 Parts A&B(US+ROW): % of Participants who Achie	—

Measure

Time frame

Secondary end point(s): *Parts A(US+ROW)&B(US): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1 *Part B(ROW): % of Participants who Achieve CLASI-70 Response, Defined as = 70% Decrease in CLASI-A Score From Baseline *Part A(US+ROW): % of Participants who Achieve a CLASI-50 Response, Defined as a = 50% Decrease in CLASI-A Score From Baseline *Part A(US+ROW): Change From Baseline in CLASI-D Score *Part B (US+ROW): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at W16&W24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score =3 and OMC Score =3 at Baseline *Part B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at W16&W24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score =3 and OMC Score =3 at Baseline *Part B(US+ROW): % of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score *Part B(US+ROW): Absolute Change in CLASI-D Score *Part B(US+ROW): Percent Change in CLASI-D Score *Part B(US+ROW): Change From Baseline in CLE-QoL Score *Part B(US+ROW): Change From Baseline in DLQI Score *Parts A(US+ROW)&B(US): % of Participants who Achieve a CLASI-70 Response, Defined as a = 70% Decrease in CLASI-A Score From Baseline *Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1 *Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline *Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0 *Parts A&B(US+ROW): % of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score *Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0 *Parts A&B(US+ROW): % of Participants who Achieve a CLASI-A Score of 0 or 1 *Parts A&B(US+ROW): % of Participants who Achieve a CLASI-A Score of 0 or 1 *Parts A&B(US+ROW): % of Participants who Achie

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Countries

Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026