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

Description

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.

Conditions

Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Subacute Cutaneous Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

Anniston

Site Number - 1010, Anniston, Alabama, United States, 36207

Birmingham

Site Number - 1020, Birmingham, Alabama, United States, 35203

San Diego

Site Number - 1018, San Diego, California, United States, 92108

Hialeah

Site Number - 1014, Hialeah, Florida, United States, 33012

Miami Lakes

Site Number - 1011, Miami Lakes, Florida, United States, 33014

Sugar Hill

Site Number - 1009, Sugar Hill, Georgia, United States, 30518

Saint Clair Shores

Site Number - 1003, Saint Clair Shores, Michigan, United States, 48081

Southfield

Site Number - 1013, Southfield, Michigan, United States, 48034

Saint Joseph

Site Number - 1004, Saint Joseph, Missouri, United States, 64506

Charlotte

Site Number - 1007, Charlotte, North Carolina, United States, 28211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunovant Sciences GmbH,

Study Record Dates

2027-04