A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Immunovant Sciences GmbH
Study ID
NCT06980805
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Cutaneous Lupus Erythematosus
  • Subacute Cutaneous Lupus Erythematosus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMVT-1402 — DRUG
    Dose 1 or Dose 2 SC QW
  • Placebo — DRUG
    Matching Placebo SC QW

Study Details

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.

Key Dates

Start date
Feb 19, 2025
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Period 1: Placebo
    Matching placebo for 12 weeks in Period 1
  • Experimental: IMVT-1402 Subcutaneous (SC) Once weekly (QW)
    * Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks * Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks * Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks

Primary Outcome Measure

Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]

Locations (33)

FacilityCityStateZIPSite coordinators
Site Number - 1010AnnistonAlabama36207-4780-
Site Number - 1020BirminghamAlabama35203-4050-
Site Number - 1038PhoenixArizona85037-
Site Number - 1034ScottsdaleArizona85260-
Site Number - 1022Beverly HillsCalifornia90211-
Site Number - 1018Chula VistaCalifornia91910-
Site Number - 1039CoronaCalifornia92882-
Site Number - 1005FremontCalifornia94538-
Site Number - 1023Los AngelesCalifornia90045-
Site Number - 1000AuroraColorado80045-2541-
Site Number - 1033Castle RockColorado80109-8034-
Site Number - 1021FarmingtonConnecticut06030-2840-
Site Number - 1014HialeahFlorida33012-
Site Number - 1017JacksonvilleFlorida32256-
Site Number - 1024MiamiFlorida33133-
Site Number - 1027MiamiFlorida33136-
Site Number - 1028MiamiFlorida33122-
Site Number - 1011Miami LakesFlorida33014-5602-
Site Number - 1025OrlandoFlorida32819-
Site Number - 1009BufordGeorgia30518-8721-
Site Number - 1030BrightonMassachusetts02135-
Site Number - 1019Auburn HillsMichigan48326-3396-
Site Number - 1003Saint Clair ShoresMichigan48081-1274-
Site Number - 1013TroyMichigan48084 3536-
Site Number - 1004Saint JosephMissouri64506-2459-
Site Number - 1026St LouisMissouri63104-
Site Number - 1007CharlotteNorth Carolina28211-1064-
Site Number - 1008DurhamNorth Carolina27713-8505-
Site Number - 1006SmithfieldNorth Carolina27577-4664-
Site Number - 1002HersheyPennsylvania17033-
Site Number - 1015PhiladelphiaPennsylvania19103-4708-
Site Number - 1035HoustonTexas77030-
Site Number - 1012IrvingTexas75061-

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Site Number - 1010· Anniston, ALSite Number - 1020· Birmingham, ALSite Number - 1038· Phoenix, AZSite Number - 1034· Scottsdale, AZSite Number - 1022· Beverly Hills, CASite Number - 1018· Chula Vista, CA

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