IMVT-1402 for Lupus

Recruiting at 12 trial locations

Overseen By Central Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Immunovant Sciences GmbH

Must be taking: Corticosteroids, Antimalarials

Disqualifiers: Drug-induced CLE, Nephritis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for individuals with Cutaneous Lupus Erythematosus, including those with discoid or systemic forms. Participants must meet certain health criteria to join. Specific inclusion and exclusion details are not provided but typically involve meeting diagnostic criteria and not having conditions that could interfere with the study.

Inclusion Criteria

My lupus affecting the skin has been confirmed by a biopsy.

I have CLE and treatments like corticosteroids or antimalarial drugs for over 12 weeks didn't work for me.

My skin condition is severe, scoring 10 or more, or 8-9 without hair loss or mouth/nose sores.

Exclusion Criteria

I may have a condition caused by medication, affecting my blood or brain related to lupus.

I don't have a skin condition that could affect study assessments, except for SCLE/CCLE.

My kidney inflammation is worsening quickly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 7 weeks

Treatment Period 1

Participants are randomized to receive either IMVT-1402 600 mg or placebo subcutaneously once weekly for 12 weeks

12 weeks

Treatment Period 2

Participants receive IMVT-1402 600 mg subcutaneously once weekly for 14 weeks

14 weeks

Treatment Period 3

Participants are re-randomized to receive blinded IMVT-1402 600 mg or 300 mg subcutaneously once weekly for 26 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 8 weeks

Treatment Details

Interventions

• IMVT-1402

Trial Overview The trial tests IMVT-1402's effectiveness in treating CLE compared to a placebo. It has three periods: an initial 12-week phase where participants get either IMVT-1402 or placebo, a 14-week treatment phase with IMVT-1402, followed by a 26-week phase of varied dosages.

Participant Groups

Group I: IMVT-1402 Subcutaneous (SC) Once weekly (QW) Experimental Treatment 1 Intervention

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

Group II: Period 1: Placebo Placebo Group 1 Intervention

Matching placebo for 12 weeks in Period 1

Who Is Running the Clinical Trial?

Immunovant Sciences GmbH

Lead Sponsor

Trials

12

Recruited

1,400+