IMVT-1402 for Lupus

Recruiting at 76 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the effectiveness and safety of a new treatment called IMVT-1402 for individuals with Cutaneous Lupus Erythematosus, a skin condition that often causes rashes and sores. Participants will receive either the treatment or a placebo (a non-active substance) to compare results. Eligible participants must have a confirmed diagnosis of specific types of lupus and active skin symptoms despite previous treatments. The trial involves three phases, each with different doses and durations of the treatment. Individuals with ongoing skin issues due to lupus who meet the criteria may find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that IMVT-1402 is likely to be safe for humans?

Research shows that IMVT-1402 is being tested for safety and tolerance in people with Cutaneous Lupus Erythematosus. Earlier studies tested this drug for other conditions like Myasthenia Gravis and Graves' disease, finding it generally safe and well-tolerated by participants.

While detailed safety data for Cutaneous Lupus Erythematosus is not yet available, testing in similar conditions suggests reasonable safety so far. The current study is in the middle phase, and early results have not revealed major safety concerns. However, participants should be aware that some side effects might still emerge as research continues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Researchers are excited about IMVT-1402 for lupus because it offers a potentially novel approach to treating this autoimmune disease. Unlike traditional treatments like corticosteroids and immunosuppressants, which often come with significant side effects, IMVT-1402 is administered subcutaneously once a week, potentially improving convenience and patient adherence. It also targets specific pathways involved in lupus, which might offer more precise symptom control with fewer side effects. This makes IMVT-1402 a promising option for those seeking alternative therapies with a different mechanism of action.

What evidence suggests that IMVT-1402 might be an effective treatment for lupus?

Research is investigating IMVT-1402 as a potential treatment for Cutaneous Lupus Erythematosus, a condition that affects the skin. Early results suggest that IMVT-1402 may help by modulating the immune system, potentially reducing inflammation and skin flare-ups. Participants in this trial will receive either IMVT-1402 or a placebo. Although detailed information from human studies is still being gathered, the mechanism appears promising. The primary focus is on assessing its safety and effectiveness in relieving lupus symptoms. More definitive results will emerge as studies progress. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

* 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

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+

Citations

1. dukehealth.org dukehealth.org/clinical-trials/directory/pro00117318

IMVT-1402-2701 - Clinical Trial We are doing this study to find out if an experimental drug called IMVT-1402 (the study drug) can help control cutaneous lupus erythematosus (CLE).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06980805

NCT06980805 | A Study to Assess the Safety, Tolerability ... The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.

3. trials.arthritis.org trials.arthritis.org/trials/NCT06980805

A Study to Assess the Safety, Tolerability, and Efficacy of IMVT ... The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus. The ...

4. immunovant.com immunovant.com/investors/news-events/press-releases/detail/72/immunovant-announces-next-phase-of-growth-with-roivant

Immunovant Announces Next Phase of Growth with ... Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced ...

5. withpower.com withpower.com/trial/imvt-1402-for-lupus-fec19

IMVT-1402 for Lupus The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.The ...

6. clinicaltrials.eu clinicaltrials.eu/inn/imvt-1402/

IMVT-1402 – Application in Therapy and Current ... These trials are evaluating how well IMVT-1402 works and its safety profile in conditions including Cutaneous Lupus Erythematosus, Myasthenia Gravis, Graves' ...