Phase 3 Long-term Extension Study to Evaluate BIIB059 in Active CLE

A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult 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 LTE)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041240127

Enrollment

322

Registered

2024-11-21

Start date

2024-11-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Active Subacute Cutaneous Lupus Erythematosus /Chronic Cutaneous Lupus Erythematosus(CCLE)

Interventions

Research Name: BIIB059 Generic Name: litifilimab Trade Names: Not applicable Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants who completed the parent study (Study 230LE301, Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52)

Exclusion criteria

Exclusion criteria: 1. Early Part A or Part B parent study treatment terminators (participants who discontinued study treatment before Week 48). 2. Early Part A or Part B parent study terminators (participants who withdrew from parent study participation before Week 52 and did not complete the parent study ETP). 3. Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the LTE study unsuitable in the opinion of the Investigator. NOTE: Other protocol defined Exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	—

Secondary

Measure	Time frame
Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 Cumulative Duration of Sustained CLASI-70 Response, Defined as the Number of Weeks With 70% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Cumulative Duration of Sustained CLASI-50 Response, Defined as the Number of Weeks With 50% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Cumulative Duration of Sustained CLASI-90 Response, Defined as the Number of Weeks With 90% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Erythema Score of 0 or 1 Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R OMC Score of 0 or 1 and Improvement of at Least 1 Point From Baseline Value (Parent Study [NCT05531565]) Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Follicular Activity Score of 0 Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Week 52 of the Parent Study (NCT05531565) Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT0553156	—

Measure

Time frame

Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 Cumulative Duration of Sustained CLASI-70 Response, Defined as the Number of Weeks With 70% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Cumulative Duration of Sustained CLASI-50 Response, Defined as the Number of Weeks With 50% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Cumulative Duration of Sustained CLASI-90 Response, Defined as the Number of Weeks With 90% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Erythema Score of 0 or 1 Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R OMC Score of 0 or 1 and Improvement of at Least 1 Point From Baseline Value (Parent Study [NCT05531565]) Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Follicular Activity Score of 0 Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Week 52 of the Parent Study (NCT05531565) Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at Week 52 of the Parent Study (NCT0553156

—

Countries

Argentina, Brazil, Bulgaria, Canada, Chile, France, Germany, Hungary, Italy, Japan, Korea, Slovakia, Spain, Sweden, Switzerland, UK, USA

Contacts

Public ContactBiogen Japan Medical Information

Biogen Japan Ltd.

japan-medinfo@biogen.com+81-120-560-086

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026