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)
Phase 2/3 Study to Evaluate BIIB059 in Active CLE
Matsuda Naoto
Biogen Japan Ltd.
Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027
+81-120-560-086
japan-medinfo@biogen.com
Biogen Japan Medical Information
Biogen Japan Ltd.
Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027
+81-120-560-086
japan-medinfo@biogen.com
Recruiting
Aug. 31, 2023
Nov. 29, 2023
474
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
- 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.
- 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.
18age old over
No limit
Both
Active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to
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.
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.
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.
- Proportion of participants with CLASI 70 response at Week 52 among CLASI 70 nonresponders at Week 16 and Week 24, who were randomly assigned to receive placebo during the DBPC treatment period.
- Annualized mild and moderate SFI rate and annualized severe SFI rate through Week 16.
- Change from Baseline to Week 52 in CLASI-D score.
- Annualized mild and moderate SFI rate, and annualized severe SFI rate through Week 52.
- Incidence of TEAEs and SAEs during the study.
- Incidence of anti-BIIB059 antibodies in serum during the study.
Part B
- Proportion of participants who achieve a CLA IGA R OMC score of 0 or 1, and at least 1 level of improvement from Baseline, skin disease activity at Week 16.
- Proportion of participants who achieve a CLASI 70 response, defined as a >= 70% decrease in baseline CLASI-A score at Week 16.
- 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 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 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 >= 3 and OMC score >= 3 at Baseline.
- Proportion of participants who achieve at least 1 level of improvement from Baseline in the CLA IGA R Erythema score.
- Proportion of participants who achieve at least 1 level of improvement from Baseline in the CLA IGA R OMC score.
- 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 (US) and at Week 24 (ROW), respectively, 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 of 1 level of improvement from Baseline, at Week 52 among at Week 16 (US) or at Week 24 (ROW), who were randomly assigned to receive BIIB059 during the DBPC treatment period.
- Proportion of participants with a CLASI 70 response at Week 52 among CLASI-70 nonresponders at Week 16 (US) or at Week 24 (ROW), who were randomly assigned to receive placebo during the DBPC treatment period.
- Annualized mild and moderate SFI rate and annualized severe SFI rate through Week 16.
- Absolute and percent change in CLASI D at Week 52.
- Annualized mild and moderate SFI rate, and annualized severe SFI rate through Week 52.
- Change from baseline at Week 16 (US) and at Week 24 (ROW) in :
- CLE-QoL
- DLQI
- Change from Baseline at Week 52 in:
- CLE-QoL
- DLQI
- Incidence of TEAEs and SAEs during the study.
- Incidence of anti-BIIB059 antibodies in serum during the study.
Biogen Japan Ltd.
Doujin Memorial Medical Foundation, Meiwa Hospital Institutional Review Board
1-18, Kandasudacho, Chiyoda-ku, Tokyo
+81-3-5543-0196
Approval
June. 23, 2023
Yes
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
