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RECRUITINGPhase 2INTERVENTIONAL

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

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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/Exclusion criteria may apply Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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/Exclusion criteria may apply

Treatments Being Tested

DRUG

IMVT-1402

Dose 1 or Dose 2 SC QW

DRUG

Placebo

Matching Placebo SC QW

Locations (20)

Site Number - 1010
Anniston, Alabama, United States
Site Number - 1020
Birmingham, Alabama, United States
Site Number - 1038
Phoenix, Arizona, United States
Site Number - 1034
Scottsdale, Arizona, United States
Site Number - 1022
Beverly Hills, California, United States
Site Number - 1018
Chula Vista, California, United States
Site Number - 1039
Corona, California, United States
Site Number - 1005
Fremont, California, United States
Site Number - 1023
Los Angeles, California, United States
Site Number - 1000
Aurora, Colorado, United States
Site Number - 1033
Castle Rock, Colorado, United States
Site Number - 1021
Farmington, Connecticut, United States
Site Number - 1014
Hialeah, Florida, United States
Site Number - 1017
Jacksonville, Florida, United States
Site Number - 1028
Miami, Florida, United States
Site Number - 1024
Miami, Florida, United States
Site Number - 1027
Miami, Florida, United States
Site Number - 1011
Miami Lakes, Florida, United States
Site Number - 1025
Orlando, Florida, United States
Site Number - 1009
Buford, Georgia, United States