IMVT-1402 for Graves' Disease

Recruiting at 33 trial locations

Overseen By Central Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Immunovant Sciences GmbH

Must be taking: Antithyroid drugs

Disqualifiers: Radioactive iodine, Thyroidectomy, Autoimmune diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IMVT-1402 for individuals with Graves' disease, a condition characterized by an overactive thyroid. The goal is to determine if this treatment is safe and effective for those who still have high thyroid levels despite other thyroid medications. Participants will receive one of two doses of IMVT-1402 or a placebo (a harmless pill with no effect). The trial seeks adults with Graves’ disease who continue to experience hyperthyroidism (high thyroid activity) despite current treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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

The trial information does not specify if you need to stop your current medications. However, since the study involves participants who are hyperthyroid despite antithyroid drug treatment, it seems likely that you may continue your current antithyroid medications.

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

Research has shown that IMVT-1402 appears safe for people with Graves' disease. In a study on this treatment, participants generally tolerated it well. The safety results matched those of similar medications. Although specific side effects are not listed, consistent safety reports suggest that IMVT-1402 could be a reliable option for patients. As a Phase 2 trial, this phase examines its safety in a larger group, following initial human testing for basic safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Graves' disease?

Unlike the standard treatments for Graves' Disease, which often involve antithyroid drugs, radioactive iodine, or surgery, IMVT-1402 offers a new approach by targeting the condition with a different mechanism of action. Researchers are excited about IMVT-1402 because it is designed to modulate the immune response specifically, potentially reducing side effects and providing a more targeted treatment option. This unique feature could mean better management of Graves' Disease symptoms with fewer complications, making it a promising alternative to existing therapies.

What evidence suggests that IMVT-1402 might be an effective treatment for Graves' disease?

Research has shown that IMVT-1402 may help treat Graves' disease. In this trial, participants will receive either IMVT-1402 at different doses or a placebo. Earlier studies demonstrated significant improvements in patients using a similar treatment, with about 50% achieving remission without antithyroid drugs six months after treatment. Another study found that IMVT-1402 led to important changes in patients who did not respond to standard treatments. These findings suggest that IMVT-1402 might effectively manage Graves' disease by potentially reducing the need for ongoing medication. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with Graves' disease who still have hyperthyroidism despite taking antithyroid drugs. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

Other, more specific inclusion criteria are defined in the protocol

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

I am 18 years old or older.

Exclusion Criteria

Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk

Additional exclusion criteria are defined in the protocol

I have severe active thyroid eye disease and might need surgery or other treatments soon.

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 in a double-blind manner

12 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 study is testing IMVT-1402's effectiveness, safety, and tolerability against a placebo in treating Graves' disease. Participants will be randomly assigned to either the drug or placebo group in a double-blind manner, meaning neither they nor the researchers know who receives which treatment.

How Is the Trial Designed?

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

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

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Immunovant Sciences GmbH

Lead Sponsor

Trials

12

Recruited

1,400+

Citations

1. immunovant.com immunovant.com/investors/news-events/press-releases/detail/75/immunovant-unveils-durability-and-treatment-free-six-month

Press Releases Two potentially registrational trials of Immunovant's lead compound IMVT-1402 in Graves' disease will evaluate 600 mg dose for up to 52 weeks ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06727604

NCT06727604 | A Study to Assess the Efficacy, Safety, and ... This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite ...

3. bioworld.com bioworld.com/articles/723828-batoclimab-data-in-graves-could-signal-bigger-immunovant-win

Batoclimab data in Graves' could signal bigger ... Of the 17 responders to therapy, about 50% (8/17) achieved antithyroid drug (ATD)-free remission at six months following end of batoclimab ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/immunovant-touts-positive-phase-ii-batoclimab-data-as-imvt-1402-also-progresses/

Immunovant touts positive Phase II batoclimab data as ... Immunovant has reported positive results from a trial investigating its monoclonal antibody drug batoclimab in Graves' disease patients.

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

Press Releases Study in uncontrolled Graves' disease (GD) patients treated for 24 weeks showed first-ever potentially disease-modifying outcome with…...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20581844

Clinical Trials The purpose of this study is to evaluate the efficacy of IMVT-1402 as treatment for adult patient Graves' Disease.