A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Purpose
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 or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 SC QW for 26 weeks.
Conditions
- Subacute Cutaneous Lupus Erythematosus
- Chronic Cutaneous Lupus Erythematosus
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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 of the following as assessed 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 SC QW for 12 weeks - Period 2: IMVT-1402 SC QW for 14 weeks - Period 3: IMVT-1402 SC QW for 26 weeks |
|
Recruiting Locations
Site Number - 1010
Anniston, Alabama 36207
Anniston, Alabama 36207
Site Number - 1020
Birmingham, Alabama 35203
Birmingham, Alabama 35203
Site Number - 1018
San Diego, California 92108
San Diego, California 92108
Site Number - 1014
Hialeah, Florida 33012
Hialeah, Florida 33012
Site Number - 1011
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
Site Number - 1009
Sugar Hill, Georgia 30518
Sugar Hill, Georgia 30518
Site Number - 1003
Saint Clair Shores, Michigan 48081
Saint Clair Shores, Michigan 48081
Site Number - 1013
Southfield, Michigan 48034
Southfield, Michigan 48034
Site Number - 1004
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Site Number - 1007
Charlotte, North Carolina 28211
Charlotte, North Carolina 28211
Site Number - 1006
Smithfield, North Carolina 27577
Smithfield, North Carolina 27577
Site Number - 1015
Philadelphia, Pennsylvania 19013
Philadelphia, Pennsylvania 19013
Site Number - 1012
Grapevine, Texas 76051
Grapevine, Texas 76051
More Details
- NCT ID
- NCT06980805
- Status
- Recruiting
- Sponsor
- Immunovant Sciences GmbH
Detailed Description
The total study duration per participant is up to 67 weeks.