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

• Research type

  Research Study

• Full 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

• IRAS ID

  1011572

• Contact name

  Jody Roth

• Contact email

  jody.roth@immunovant.com

• Sponsor organisation

  Immunovant Sciences GmbH

• Clinicaltrials.gov Identifier

  NCT06980805

• Research summary

  Cutaneous Lupus Erythematosus (CLE) is a disease where the immune system, which usually protects the body from germs and infections, makes antibodies (proteins in the blood usually produced to fight off germs) that mistakenly attack the skin. This causes rashes, sores, scars, and hair loss.
  This study will test a new treatment, IMVT-1402, and test how well it works for CLE.
  Researchers will measure:
  • How much skin problems improve with IMVT-1402 treatment at 2 different doses;
  • The changes in quantity of antibodies in the body;
  • How participants feel during the study and the impact of the disease on their daily activities;
  • Any side effects of IMVT-1402 treatment

  Study parts:
  •Screening: Researchers will check if participants can enter the study.
  • Three Treatment Periods:
  Period 1: Participants will take either IMVT-1402 600 mg or placebo every week for 12 weeks. Participants and researchers will not know who is getting IMVT-1402 or placebo.
  Period 2: All participants will take IMVT-1402 600 mg every week for 14 weeks.
  Period 3: Participants will take either IMVT-1402 600 mg or IMVT-1402 300 mg for 26 weeks. Participants and researchers will not know which treatment of IMVT-1402 they will receive.
  • Safety Follow-up : Participants will not take any study treatment for 4 weeks.
  During the study , all participants will take their CLE medication that are allowed in the study.
  Participants will be in the study for up to 61 weeks total.

• REC name

  Wales REC 5

• REC reference

  25/WA/0082

• Date of REC Opinion

  22 Apr 2025

• REC opinion

  Further Information Favourable Opinion