AMETHYST LTE
Research type
Research Study
Full title
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)
IRAS ID
1008524
Contact name
CTA Lead Department CTA Lead Department
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2023-504863-17
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3, multicentre, open-label, single-arm, Long-Term Extension (LTE) of 2 years’ duration for 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.
This study will be conducted in participants who completed the parent 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).
All participants in this LTE study will receive study drug BIIB059 (litifilimab) 225 mg subcutaneously during the study treatment period. There will be no use of placebo in this LTE study.
The total study duration for each participant will be approximately 128 weeks:
• LTE treatment period of 104 weeks (up to 27 visits)
• Safety Follow-Up period of 24 weeks (up to 6 visits)Approximately 322 participants will be enrolled at approximately 239 sites globally. Sites that enrolled participants in the parent study will be included in this LTE study.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0914
Date of REC Opinion
3 Jan 2024
REC opinion
Further Information Favourable Opinion