A Phase 2b Study to Assess IMVT-1402 in Participants with Cutaneous Lupus Erythematosus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Immunovant Sciences GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

11 Jul 2025 → ongoing

Decision date (initial)

2025-06-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516745-39-00

ClinicalTrials.gov

NCT06980805

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Dose response, Therapy, Pharmacogenetic, Safety, Pharmacodynamic

To evaluate the efficacy of IMVT-1402 compared to placebo in participants with CLE as assessed by changes in the CLASI-A score.

Conditions and MedDRA coding

Cutaneous lupus erythematosus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.
2. 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.
3. Have active CLE despite an adequate trial of conventional therapies (defined as either corticosteroids or an antimalarial agent used for at least 12-week 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 and poor tolerability.
4. Are positive for at least one of the following as assessed at Screening: a. ANA; b. elevated anti-double-stranded DNA; c. anti-Ro/SSA; d. anti-La/SSB; e. anti-Sm; f. anti-RNP70; g. positive direct immunofluorescence confirming IgG deposition in a skin biopsy.

Exclusion criteria 3

1. Have known or suspected drug-induced CLE, anti-phospholipid disease, or neuropsychiatric SLE.
2. Have rapidly progressive nephritis.
3. 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 disease activity assessments.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Immunovant Sciences GmbH

Sponsor organisation

Immunovant Sciences GmbH

Address

Viaduktstrasse 8

City

Basel Town

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

Immunovant Sciences GmbH

Contact name

Immunovant Clinical Trials

Public contact point

Organisation

Immunovant Sciences GmbH

Contact name

Immunovant Clinical Trials

Third parties 19

Locations

5 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 90 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications