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.
The total study duration per participant is approximately 61 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Dose 1 or Dose 2 SC QW
Matching Placebo SC QW
Site Number - 1010
Anniston, Alabama, United States
RECRUITINGSite Number - 1020
Birmingham, Alabama, United States
RECRUITINGSite Number - 1038
Phoenix, Arizona, United States
RECRUITINGSite Number - 1034
Scottsdale, Arizona, United States
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at 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.
Time frame: Baseline (Day 1) and Week 12
Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 1) and Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Number - 1022
Beverly Hills, California, United States
RECRUITINGSite Number - 1018
Chula Vista, California, United States
RECRUITINGSite Number - 1005
Fremont, California, United States
RECRUITINGSite Number - 1023
Los Angeles, California, United States
RECRUITINGSite Number - 1000
Aurora, Colorado, United States
RECRUITINGSite Number - 1033
Castle Rock, Colorado, United States
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