IMVT-1402 for Myasthenia Gravis

Recruiting at 31 trial locations

Overseen By Central Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Immunovant Sciences GmbH

Disqualifiers: Myasthenic crisis, Thymectomy, Malignant thymoma, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

231 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a new treatment, IMVT-1402, for individuals with generalized myasthenia gravis (gMG), a condition that causes muscle weakness. The researchers aim to assess the safety and tolerability of this treatment over 26 weeks. Participants will receive either one of two different doses of IMVT-1402 or a placebo, which contains no active medicine. The trial seeks adults with mild to severe gMG who find daily activities challenging due to this condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

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

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

Research is examining the safety of IMVT-1402 for treating myasthenia gravis, a condition that causes muscle weakness. Early studies show that treatments similar to IMVT-1402, such as batoclimab, have been well-tolerated by patients. These studies have demonstrated positive safety results, although detailed information on side effects remains limited.

IMVT-1402 is also undergoing tests for other conditions, like CIDP, a nerve disorder, indicating ongoing research to understand its safety across different diseases. Since it is in a late phase of testing, it has already passed earlier safety assessments, suggesting it might be well-tolerated by most people. However, more detailed safety data from these ongoing studies would provide clearer information. ^{1 2 3 4 5}

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

Researchers are excited about IMVT-1402 for treating Myasthenia Gravis because it offers a new approach compared to current options like acetylcholinesterase inhibitors and immunosuppressants. IMVT-1402 targets a different pathway, potentially offering a more direct influence on the immune system's role in this condition. This treatment could lead to improved outcomes and faster symptom relief for patients, setting it apart from the traditional treatments that often take longer to show results.

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

Research has shown that IMVT-1402 may help treat myasthenia gravis (MG), a condition affecting muscle strength. In this trial, participants will receive varying doses of IMVT-1402 or a placebo. A similar treatment, batoclimab, improved patients' ability to perform daily activities by 5.6 points after 12 weeks. This suggests that IMVT-1402, considered potentially top-notch, might also be effective. The treatment blocks a protein involved in the immune system, which could help reduce MG symptoms. Although IMVT-1402 remains under study, these results are promising for its potential effectiveness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with mild to severe generalized myasthenia gravis. Specific eligibility details are not provided, but typically participants must meet certain health criteria and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

I understand the trial's requirements and can follow its procedures.

Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)

My myasthenia gravis is classified from mild to severe.

Exclusion Criteria

I had a myasthenic crisis in the last 12 weeks.

I do not have an active or untreated thymoma.

I had my thymus gland removed less than 6 months ago or will have it removed during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IMVT-1402 or placebo for 26 weeks to assess efficacy, safety, and tolerability

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IMVT-1402

Trial Overview The trial is testing IMVT-1402 against a placebo over 26 weeks to see if it's effective and safe for treating myasthenia gravis. Participants will randomly receive either the actual medication or a placebo.

How Is the Trial Designed?

Group I: Group 2: IMVT-1402 Dose 2 Experimental Treatment 1 Intervention

Group II: Group 1: IMVT-1402 Dose 1 Experimental Treatment 1 Intervention

Group III: Placebo/ IMVT-1402 Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Immunovant Sciences GmbH

Lead Sponsor

Trials

12

Recruited

1,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07039916

Study to Access the Efficacy and Safety of IMVT-1402 in ... This is a 26-week study to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.

2. immunovant.com immunovant.com/investors/news-events/press-releases/detail/71/immunovant-announces-positive-results-for-batoclimab

Immunovant Announces Positive Results for Batoclimab ... Pivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in ...

3. investor.roivant.com investor.roivant.com/static-files/e931a0b1-0bf6-4fae-9530-0ff2e78f7cb7

Targeted science, Tailored solutions Batoclimab data positions IMVT-1402 as potentially best-in-class FcRn and enables acceleration of IMVT-1402 registration programs in MG and CIDP. 36. Notes ...

4. immunovant.com immunovant.com/investors/news-events/press-releases/detail/77/immunovant-provides-corporate-updates-and-reports-financial

Press Releases The Immunovant study in uncontrolled GD patients treated for 24 weeks showed first-ever potentially disease-modifying therapy with six-month off ...

5. rarediseaseadvisor.com rarediseaseadvisor.com/news/investigate-imvt-1402-patients-cidp/

IMVT-1402 Evaluated for Use in Patients With CIDP Batoclimab showed positive results in studies of myasthenia gravis (MG) and CIDP but is not currently planning to seek regulatory approval for ...

6. ctv.veeva.com ctv.veeva.com/study/study-to-access-the-efficacy-and-safety-of-imvt-1402-in-participants-with-mild-to-severe-generalized

Study to Access the Efficacy and Safety of IMVT-1402 in ... This is a 26-week study to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.