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)

简要总结

主要结局

次要结局

• 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) [Time Frame: Up to 128 weeks]
• Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Improvement in CLASI-A Score from the Baseline Value (Parent Study) [Time Frame: Up to 128 weeks]
• Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Improvement in CLASI-A Score from the Baseline Value (Parent Study) [Time Frame: Up to 128 weeks]
• Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 [Time Frame: Up to 128 weeks]
• Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 [Time Frame: Up to 128 weeks]
• 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) [Time Frame: Up to 128 weeks]
• 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) [Time Frame: Up to 128 weeks]
• 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) [Time Frame: Up to 128 weeks]
• Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Erythema Score of 0 or 1 [Time Frame: Up to 128 weeks]
• 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) [Time Frame: Up to 128 weeks]
• Cumulative Duration of Sustained Efficacy, Defined as the Number of Weeks With CLA-IGA-R Follicular Activity Score of 0 [Time Frame: Up to 128 weeks]
• Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Week 52 of the Parent Study [Time Frame: Day 0 (Week 52 of parent study) up to 128 weeks]
• Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at Week 52 of the Parent Study [Time Frame: Day 0 (Week 52 of parent study) up to 128 weeks]
• Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at Week 52 of the Parent Study [Time Frame: Day 0 (Week 52 of parent study) up to 128 weeks]
• Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 Among Participants With aCLA-IGA-R Erythema Score of 0 or 1 at Week 52 of the Parent Study [Time Frame: Day 0 (Week 52 of parent study) up to 128 weeks]
• Percentage of Participants With a CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Value (Parent Study) Among Participants With a CLA IGA R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Value (Parent Study) [Time Frame: Day 0 (Week 52 of parent study) up to 128 weeks]
• Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at Week 52 of the Parent Study [Time Frame: Day 0 (Week 52 of parent study) up to 128 weeks]
• Percentage of Participants With a CLASI-90 Response Among CLASI-50 Responders at Week 52 of the Parent Study [Time Frame: Day 0 (Week 52 of parent study) up to 128 weeks]
• Percentage of Participants With a CLASI-90 Response Among CLASI-70 Responders at Week 52 of the Parent Study [Time Frame: Day 0 (Week 52 of parent study) up to 128 weeks]
• Percentage of Participants With Loss of Response, Defined as an Increase of ≥ 7 Points in CLASI-A Total Score From Baseline [Time Frame: Baseline (Day 0) up to 128 weeks]
• Percentage of Participants With Loss of Response, Defined as Achieving 2 Points Improvement From Baseline Value (Parent Study) CLA-IGA-R Erythema Score at the Beginning of/ During the LTE Study and Then Relapsing to the CLA-IGA-R Erythema Baseline Value (Parent Study) [Time Frame: Up to 128 weeks]
• Percentage of Participants With Loss of Response, Defined as Having at Least 2, 3, and 4 Points Worsening in CLA-IGA-R Erythema Score From Their Minimum Score in Parent Study [Time Frame: Up to 128 weeks]
• Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From the Baseline (Parent Study) to Week 104 [Time Frame: Up to 104 weeks]
• Percent Change in CLASI-D Score From the Baseline (Parent Study) to Week 104 [Time Frame: Up to 104 weeks]
• Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates Through Week 52 [Time Frame: Up to 52 weeks]
• Annualized Mild/Moderate and Severe SFI Rates Through Week 104 [Time Frame: Up to 104 weeks]
• Percentage of Participants With Oral Corticosteroid (OCS) Dose [Time Frame: Up to 104 weeks]
• Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day) [Time Frame: Up to 104 weeks]
• Percentage of Participants With OCS ≤ 5.0 mg/day [Time Frame: Up to 104 weeks]
• Change From Baseline Value (Parent Study) in Cutaneous Lupus Erythematosus –Quality of Life (CLE-QoL) at Weeks 52 and 104 [Time Frame: Baseline, Weeks 52 and 104]
• Change From Baseline Value (Parent Study) in European Quality of Life – 5-Dimensions Questionnaire, 3-Level Version (EQ-5D-3L) at Weeks 52 and 104 [Time Frame: Baseline, Weeks 52 and 104]
• Change From Baseline Value (Parent Study) in 36-Item Short Form Survey (SF-36)(acute version) at Weeks 52 and 104 [Time Frame: Baseline, Weeks 52 and 104]
• Change From Baseline Value (Parent Study) in Work Productivity and Activity Impairment (WPAI): Lupus at Weeks 52 and 104 [Time Frame: Baseline, Weeks 52 and 104]
• Change From Baseline Value (Parent Study) in Patient Health Questionnaire-9(PHQ-9) at Weeks 52 and 104 [Time Frame: Baseline, Weeks 52 and 104]
• Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study) in Standard Laboratory Parameters [Time Frame: Up to 128 weeks]
• Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study) in ECG Results [Time Frame: Up to 104 weeks]
• Number of Participants With Anti-BIIB059 (litifilimab) Antibodies in Serum [Time Frame: Up to 128 weeks]
• Serum Concentration of Litifilimab [Time Frame: Pre-dose up to 128 weeks]
• Change From Baseline Value (Parent Study) in Subject Global Assessment of Skin - Follow-up (SGA-Skin-FU) at Weeks 52 and 104 [Time Frame: Baseline, Weeks 52 and 104]
• Change From Baseline Value (Parent Study) in Numerical Rating Scale (NRS) for Pain in Skin Rash at Weeks 52 and 104 [Time Frame: Baseline, Weeks 52 and 104]
• Change From Baseline Value (Parent Study) in Numerical Rating Scale (NRS) for Itch in Skin Rash at Weeks 52 and 104 [Time Frame: Baseline, Weeks 52 and 104]