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

Immunovant

Status and phase: Enrolling; Phase 2

Conditions: Subacute Cutaneous Lupus Erythematosus; Chronic Cutaneous Lupus Erythematosus

Treatments: Drug: IMVT-1402; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06980805

IMVT-1402-2701

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

Period 1: Placebo

Placebo Comparator group

Description:

Matching placebo for 12 weeks in Period 1

Treatment:

Drug: Placebo

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

Experimental group

Description:

* 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

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

IMVT-1402 300 mg SC QW

Experimental group

Description:

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

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402