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)

Chronic Cutaneous Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus

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. Time frame: Week 16., 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. Time frame: baseline to Week 24.

Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50%Decrease in CLASI-A Score From Baseline Time frame: Weeks 16 and 24., Part A (US+ROW): Absolute Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score at Week 52. Time frame: Baseline to Week 52., Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline. Time frame: Weeks 16 and 24., Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3and OMC Score ≥3 at Baseline. Time frame: Weeks 16 and 24., Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score. Time frame: Up to Week 24., Part B (US+ROW): Absolute Change in CLASI-D Score. Time frame: Week 52., Part B (US+ROW): Percent Change in CLASI-D Score. Time frame: Week 52., Part B (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score. Time frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52., Part B (US+ROW): Change From Baseline in Dermatology Life Quality Index (DLQI) Score. Time frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52., Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16., Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1. Time frame: Part A (US+ROW): Week 24; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24., Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16; Part B (ROW): Week 24; Part B (US+ROW):Up to Week 24., Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24., Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24., Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0. Time frame: Parts A and B (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24., Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1. Time frame: Up to Week 24., Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3. Time frame: Up to Week 24., Parts A and B (US+ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A. Time frame: Up to Week 24., Parts A and B (US+ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A. Time frame: Up to Week 24., Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score. Time frame: Up to Week 24., Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 AmongCLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC Treatment Period (TP). Time frame: Week 52., Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP. Time frame: Week 52., Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16and 24, Respectively, who Were Assigned to Receive Litifilimab in DBPC TP. Time frame: Week 52., Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Litifilimab During the DBPC TP. Time frame: Week 52., Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab in DBPC TP. Time frame: Week 52., Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 AmongCLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP. Time frame: Week 52., Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP. Time frame: Week 52., Parts A, B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TP. Time frame: Week 52., Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP. Time frame: Week 52., Parts A and B(US+ROW): Percentage of Participants who Achieve CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24,Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP. Time frame: Week 52., Parts A and B (US+ROW): Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Week 24. Time frame: Up to Week 24., Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16. Time frame: Up to Week 16., Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52. Time frame: Up to Week 52., Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). Time frame: Up to Week 76., Percent Change in CLASI-D Score. Time Frame: Baseline to Week 52., Part B (US+ROW): Change From Baseline in Numerical Rating Scale (NRS) for Pain in Skin Rash. Time Frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52., Part B (US+ROW): Change From Baseline in NRS for Itch in Skin Rash. Time Frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52., Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI 70 Response. Time Frame: Up to Week 24., Parts A and B (US+ROW): Number of Participants With Anti-Litifilimab Antibodies in Serum During the Study. Time Frame: Up to Week 76

No related papers found yet.

Belgium, Bulgaria, France, Germany, Hungary, Italy, Poland, Portugal, Slovakia, Spain, Sweden