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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516745-39-00

Acronym

IMVT-1402-2701

Enrollment

Registered

2025-06-24

Start date

2025-07-11

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous lupus erythematosus

Brief summary

Percent change from Period 1 baseline in CLASI-A score at Week 12.

Detailed description

Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12, Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12, Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12

Interventions

DRUGIMVT-1402

DRUGPlacebo is identical to the IMP but with no active substance.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from Period 1 baseline in CLASI-A score at Week 12.	—

Secondary

Measure	Time frame
Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12, Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12, Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12	—

Countries

Bulgaria, Germany, Greece, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026