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

Study 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 600 mg or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 600 mg SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 600 mg or 300 mg SC QW for 26 weeks.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 (defined as either corticosteroids or an antimalarial agent used for at least 12-weeks prior to Screening) OR previously documented failure to respond to these agents when used for at least 12-weeks OR the requirement to discontinue these agents due to side effects or poor tolerability.

- Are positive for at least one of the following as assessed at Screening: 1.

anti-nuclear antibody (ANA) 2. elevated anti-double-stranded deoxyribose nucleic acid (DNA) 3. anti-Sjögren's syndrome-related antigen A antibodies (anti-Ro/SSA) 4. anti-La/SSB. 5. anti-Smith antibody (anti-Sm) 6. anti-ribonucleoprotein 70 (anti-RNP70) 7. positive direct immunofluorescence confirming immunoglobulin (IgG) deposition in a skin biopsy.

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06980805
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Immunovant Sciences GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

Additional Details

The total study duration per participant is up to 67 weeks including: A screening period of up to 7 weeks. A treatment period of up to 52 weeks. A safety follow-up period of up to 8 weeks.

Arms & Interventions

Arms

Placebo Comparator: Period 1: Placebo

Matching placebo for 12 weeks in Period 1

Experimental: IMVT-1402 600 milligrams (mg) Subcutaneous (SC) Once weekly (QW)

- Period 1: IMVT-1402 600 mg SC QW for 12 weeks - Period 2: IMVT-1402 600 mg SC QW for 14 weeks - Period 3: IMVT-1402 600 mg SC QW for 26 weeks

Experimental: IMVT-1402 300 mg SC QW

IMVT-1402 300 mg SC QW for 26 weeks in Period 3

Interventions

Drug: - IMVT-1402

600 mg SC QW

Drug: - IMVT-1402

300 mg SC QW

Drug: - Placebo

Matching Placebo SC QW

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Site Number - 1010, Anniston, Alabama

Status

Recruiting

Address

Site Number - 1010

Anniston, Alabama, 36207

Site Contact

[email protected]

8007970414

Site Number - 1020, Birmingham, Alabama

Status

Recruiting