Clinical trial NCT06980805: A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
Keywords: Chronic Cutaneous Lupus Erythematosus
Subacute Cutaneous Lupus Erythematosus
IMVT-1402
Lead sponsor: Immunovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The total study duration per participant is up to 67 weeks.

Eligibility 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.
* 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

Primary outcomes:
measure: Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12
timeFrame: Baseline (Day 1) and Week 12
Secondary outcomes:
measure: Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12
timeFrame: Baseline (Day 1) and Week 12
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Site Number - 1010
state: Alabama
city: Birmingham
country: United States
facility: Site Number - 1020
state: Alabama
city: San Diego
country: United States
facility: Site Number - 1018
state: California
city: Hialeah
country: United States
facility: Site Number - 1014
state: Florida
city: Miami Lakes
country: United States
facility: Site Number - 1011
state: Florida
city: Sugar Hill
country: United States
facility: Site Number - 1009
state: Georgia
city: Saint Clair Shores
country: United States
facility: Site Number - 1003
state: Michigan
city: Southfield
country: United States
facility: Site Number - 1013
state: Michigan
city: Saint Joseph
country: United States
facility: Site Number - 1004
state: Missouri
city: Charlotte
country: United States
facility: Site Number - 1007
state: North Carolina
city: Smithfield
country: United States
facility: Site Number - 1006
state: North Carolina
city: Philadelphia
country: United States
facility: Site Number - 1015
state: Pennsylvania
city: Grapevine
country: United States
facility: Site Number - 1012
state: Texas
Study officials:
References: