Chronic Cutaneous Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus
Conditions
Keywords
Chronic Cutaneous Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, IMVT-1402, Imeroprubart
Brief summary
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus. The study will consist of 3 periods: Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.
Detailed description
The total study duration per participant is approximately 61 weeks.
Interventions
DRUGIMVT-1402
Dose 1 or Dose 2 SC QW
DRUGPlacebo
Matching Placebo SC QW
Sponsors
Immunovant Sciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations. * Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with a CLASI-A score of ≥8 and \<10 are eligible if the score does not include alopecia and/or mucous membrane lesions. * Have active CLE despite an adequate trial of conventional therapies. * Are positive for at least one autoantibody at Screening.
Exclusion criteria
* Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE. * Have rapidly progressive nephritis. * Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12 | Baseline (Day 1) and Week 12 | The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12 | Baseline (Day 1) and Week 12 |
| Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12 | Baseline (Day 1) and Week 12 |
| Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12 | Baseline (Day 1) and Week 12 |
Countries
Argentina, Bulgaria, Canada, Chile, Georgia, Germany, Greece, Poland, Puerto Rico, Serbia, Spain, United Kingdom, United States
Outcome results
None listed