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

NCT06980805 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IMVT-1402-2701
• Study Type: interventional
• Target: 56
• Locations: 13 countries
• Sites: 86

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

Conditions

Subacute Cutaneous Lupus Erythematosus; Chronic Cutaneous Lupus Erythematosus

Keywords

Chronic Cutaneous Lupus Erythematosus; Subacute Cutaneous Lupus Erythematosus; IMVT-1402; Imeroprubart

Outcome Measures

Primary Outcomes (1)

• Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12

  The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.

  Baseline (Day 1) and Week 12

Secondary Outcomes (3)

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

  Baseline (Day 1) and Week 12

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

  Baseline (Day 1) and Week 12

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

  Baseline (Day 1) and Week 12

Study Arms (2)

Period 1: Placebo

PLACEBO COMPARATOR

Matching placebo for 12 weeks in Period 1

Drug: Placebo

IMVT-1402 Subcutaneous (SC) Once weekly (QW)

EXPERIMENTAL

* Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks * Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks * Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks

Drug: IMVT-1402

Interventions

IMVT-1402 DRUG

Dose 1 or Dose 2 SC QW

IMVT-1402 Subcutaneous (SC) Once weekly (QW)

Placebo DRUG

Matching Placebo SC QW

Period 1: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 autoantibody at Screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (86)

Site Number - 1010

Anniston, Alabama, 36207-4780, United States

RECRUITING

Site Number - 1020

Birmingham, Alabama, 35203-4050, United States

RECRUITING

Site Number - 1038

Phoenix, Arizona, 85037, United States

RECRUITING

Site Number - 1034

Scottsdale, Arizona, 85260, United States

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Site Number - 1022

Beverly Hills, California, 90211, United States

RECRUITING

Site Number - 1018

Chula Vista, California, 91910, United States

RECRUITING

Site Number - 1039

Corona, California, 92882, United States

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Site Number - 1005

Fremont, California, 94538, United States

RECRUITING

Site Number - 1023

Los Angeles, California, 90045, United States

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Site Number - 1000

Aurora, Colorado, 80045-2541, United States

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Site Number - 1033

Castle Rock, Colorado, 80109-8034, United States

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Site Number - 1021

Farmington, Connecticut, 06030-2840, United States

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Site Number - 1014

Hialeah, Florida, 33012, United States

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Site Number - 1017

Jacksonville, Florida, 32256, United States

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Site Number - 1028

Miami, Florida, 33122, United States

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Site Number - 1024

Miami, Florida, 33133, United States

RECRUITING

Site Number - 1027

Miami, Florida, 33136, United States

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Site Number - 1011

Miami Lakes, Florida, 33014-5602, United States

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Site Number - 1025

Orlando, Florida, 32819, United States

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Site Number - 1009

Buford, Georgia, 30518-8721, United States

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Site Number - 1030

Brighton, Massachusetts, 02135, United States

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Site Number - 1019

Auburn Hills, Michigan, 48326-3396, United States

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Site Number - 1003

Saint Clair Shores, Michigan, 48081-1274, United States

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Site Number - 1013

Troy, Michigan, 48084 3536, United States

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Site Number - 1004

Saint Joseph, Missouri, 64506-2459, United States

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Site Number - 1026

St Louis, Missouri, 63104, United States

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Site Number - 1007

Charlotte, North Carolina, 28211-1064, United States

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Site Number - 1008

Durham, North Carolina, 27713-8505, United States

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Site Number - 1006

Smithfield, North Carolina, 27577-4664, United States

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Site Number - 1002

Hershey, Pennsylvania, 17033, United States

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Site Number - 1015

Philadelphia, Pennsylvania, 19103-4708, United States

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Site Number - 1035

Houston, Texas, 77030, United States

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Site Number - 1012

Irving, Texas, 75061, United States

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Site Number -5004

CABA, 1406, Argentina

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Site Number - 5000

CABA, C1023AAB, Argentina

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Site Number - 5001

CABA, C1425DND, Argentina

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Site Number - 5002

San Miguel de Tucumán, T4000AXL, Argentina

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Site Number - 5003

San Miguel de Tucumán, T4000IHE, Argentina

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Site Number - 5601

Sofia, 1257, Bulgaria

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Site Number - 5603

Sofia, 1431, Bulgaria

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Site Number - 5600

Sofia, 1606, Bulgaria

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Site Number - 5605

Sofia, 1618, Bulgaria

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Site Number - 5606

Sofia, 1680, Bulgaria

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Site Number - 2000

Calgary, Alberta, T2W 4X9, Canada

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Site Number - 2002

Vancouver, British Columbia, V5Z 4E8, Canada

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Site Number - 2003

Sarnia, Ontario, N7T 5W4, Canada

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Site Number - 5702

Independencia, 8380000, Chile

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Site Number - 5704

Santiago, 7640881, Chile

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Site Number - 5703

Santiago, 8320000, Chile

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Site Number - 5701

Temuco, 4810345, Chile

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Site Number - 5700

Victoria, 4720638, Chile

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Site Number - 8002

Tbilisi, 0112, Georgia

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Site Number - 8000

Tbilisi, 0160, Georgia

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Site Number - 6502

Tübingen, Baden-Wurttemberg, 72076, Germany

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Site Number - 6500

Erlangen, Bavaria, 91054, Germany

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Site Number - 6501

Oldenburg, Lower Saxony, 26133, Germany

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Site Number - 6503

Bochum, North Rhine-Westphalia, 44791, Germany

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Site Number - 3902

Attiki, Athens, 104 31, Greece

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Site Number - 3901

Athens, Attica, 16121, Greece

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Site Number - 3903

Thessaloniki, Central Macedonia, 56403, Greece

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Site Number - 3905

Thessaloniki, Central Macedonia, 56403, Greece

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Site Number - 3906

Heraklion, Crete, 71110, Greece

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Site Number - 3900

Attiki, 12462, Greece

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Site Number - 3904

Larissa, 411 10, Greece

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Site Number - 3004

Poznan, Greater Poland Voivodeship, 60-702, Poland

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Site Number - 3005

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

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Site Number - 3000

Warsaw, Masovian Voivodeship, 00-716, Poland

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Site Number - 3001

Warsaw, Masovian Voivodeship, 00-874, Poland

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Site Number - 3006

Rzeszów, Pakistan, 35-055, Poland

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Site Number - 3002

Rzeszów, Podkarpackie Voivodeship, 35-309, Poland

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Site Number - 3003

Lodz, 90-436, Poland

RECRUITING

Site Number-1029

Caguas, 00725-2443, Puerto Rico

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Site Number - 1037

Ponce, 00716-0377, Puerto Rico

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Site Number - 1036

San Juan, 918, Puerto Rico

RECRUITING

Site Number - 9000

Belgrade, 11000, Serbia

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Site Number - 9001

Belgrade, 11000, Serbia

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Site Number - 9003

Novi Sad, 21000, Serbia

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Site Number - 7104

Badalona, Catalonia, 8916, Spain

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Site Number - 7105

Pamplona, Navarre, 31008, Spain

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Site Number - 7101

Burjassot, Valencia, 46100, Spain

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Site Number - 7100

Madrid, 28003, Spain

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Site Number - 7102

Madrid, 28041, Spain

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Site Number - 7103

Málaga, 29016, Spain

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Site Number - 7002

Leeds, West Yorkshire, LS7 4SA, United Kingdom

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Site Number - 7003

London, SE1 9RT, United Kingdom

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Site Number - 7000

Manchester, M15 6SE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Central Study Contact

CONTACT

8007970414; clinicaltrials@immunovant.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 20, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (5); CA (3); GB (3); US (33); DE (4); CL (5); GE (2); SE (3); GR (7); PR (3); ES (6); BU (5); PL (7)