Active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to
Conditions
Interventions
Research Name :BIIB059
Generic Name :Litifilimab
Trade Names :Not applicable
BIIB059 SC Q4W, with an additional dose at Week 2 and Week 26, is proposed for this Phase 2/3 study.
Sponsors
Matsuda Naoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations. - Must have active cutaneous manifestations that meet criteria - Must have a CLASI-A score >= 10 - Must have an active CLE lesion despite an adequate trial of antimalarial treatment NOTE: Other protocol defined Inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: - Any active skin conditions other than CLE that may interfere with the study assessments of CLE - Active severe lupus nephritis - Active neuropsychiatric SLE - Use of intralesional corticosteroids within 1 week prior to Screening and during the study - Use of immunosuppressive or disease-modifying treatments for SLE or CLE (via an oral, 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 |
|---|---|
| Part A : Proportion of participants who achieve a CLA-IGA-R Erythema score of 0 or 1 at Week 16. Part B (US) : Proportion of participants who achieve a CLA-IGA-R Erythema score of 0 or 1 at Week 16. Part B (ROW) : Proportion of participants who achieve CLASI 70 response, defined as >= 70% decrease in CLASI-A score from Baseline to Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A - Proportion of participants who achieve a CLA IGA R Erythema score of 0 or 1 at Week 24. - Proportion of participants who achieve a CLA IGA R OMC score of 0 or 1 and at least 1 level of improvement from Baseline, at Week 16 and Week 24. - Proportion of participants who achieve a CLA IGA-R OMC score of 0, defined as clear skin disease activity at Week 16 and Week 24. - Proportion of participants with at least 1 level of improvement from Baseline in CLA IGA-R OMC score at Week 16 and Week 24. - Proportion of participants who achieve a CLA IGA-R Follicular Activity score of 0 at Week 16 and Week 24. - Proportion of participants who achieve a CLASI 70 response, defined as a >= 70% decrease in CLASI-A score from Baseline at Week 16 and Week 24. - Proportion of participants who achieve a CLASI 50 response, defined as a >= 50% decrease in CLASI-A score from Baseline at Week 16 and Week 24. - Proportion of participants who achieve a CLASI-A score of 0 or 1. - Proportion of participants who achieve a CLASI-A score of 0 to 3. - Proportion of participants who achieve a 70% reduction in CLASI-A. - Proportion of participants who achieve a 50% reduction in CLASI-A. - Proportion of participants who achieve a 7 point reduction from Baseline in CLASI-A score. - Proportion of participants with a CLASI 70 response at Week 52 among CLASI-70 responders1 at Week 16 and Week 24, respectively, who were randomly assigned to receive BIIB059 during the DBPC treatment period. - roportion of participants with a CLA IGA R Erythema score of 0 or 1 at Week 52 among CLA IGA-R Erythema responders1 at Week 16 and Week 24, who were randomly assigned to receive BIIB059 during the DBPC treatment period. - Proportion of participants with a CLA IGA R OMC score of 0 or 1 and at least 1 level of improvement from Baseline at Week 52 among responders1 with a CLA IGA R OMC score of 0 or 1 at Week 16 and Week 24, who were randomly assigned to receive BIIB059 during the DBPC treatment period. - Proport | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, UK, USA
Contacts
Public ContactBiogen Japan Medical Information
Biogen Japan Ltd.
Outcome results
None listed