IMVT-1402 for Graves' Disease

Recruiting at 91 trial locations

Overseen By Central Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Immunovant Sciences GmbH

Must be taking: Antithyroid drugs

Must not be taking: Levothyroxine, Desiccated thyroid, T3

Disqualifiers: Radioactive iodine, Thyroidectomy, Autoimmune disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the new treatment IMVT-1402, an experimental therapy, for individuals with Graves' disease who continue to have high thyroid hormone levels despite using antithyroid drugs. The main goal is to determine if this treatment can manage hormone levels more effectively than a placebo (a substance with no active medication) over 26 weeks. Participants will be divided into groups, with some receiving IMVT-1402 and others a placebo, to compare results. Individuals with Graves' disease who are currently on antithyroid medication and still have high thyroid hormone levels might be a good fit. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to continue taking their antithyroid drugs (ATD) at a stable dose before and during the study. If you are on other medications, the protocol does not specify whether you need to stop them.

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

Research shows that IMVT-1402 is undergoing safety testing in people with Graves' disease. This crucial testing phase ensures the treatment's safety for humans.

While specific safety results from earlier studies aren't available, this phase typically indicates some safety in past research. The testing examines possible side effects and patient responses to the treatment.

This emphasis on safety suggests that earlier studies have tolerated IMVT-1402 well enough to proceed with testing. As more information emerges, it will help determine the treatment's safety and effectiveness for people with Graves' disease. ^{1 2 3 4 5}

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

Researchers are excited about IMVT-1402 for Graves' Disease because it offers a fresh approach compared to existing treatments like antithyroid medications, radioactive iodine therapy, and surgery. Unlike these traditional options, IMVT-1402 is designed to target specific pathways involved in the autoimmune process of Graves' Disease, potentially reducing side effects and improving effectiveness. Its novel mechanism of action could provide a more targeted, less invasive alternative, making it an appealing option for patients and healthcare providers alike.

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

Research has shown that IMVT-1402 is under study as a potential treatment for Graves' disease, which causes an overactive thyroid. In this trial, participants will receive either IMVT-1402 or a placebo. Early findings suggest that IMVT-1402 helps adjust the immune system to lower thyroid hormone levels, which are often elevated in individuals with Graves' disease. Initial studies have shown promising results, with some patients experiencing better control of their thyroid hormone levels. This treatment aims to manage symptoms by stabilizing thyroid levels, even for those who do not respond well to other medications. While more research is needed, these early results offer hope for those seeking new treatment options. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with Graves' disease who still have hyperthyroidism despite being on antithyroid drugs. Participants must have a confirmed diagnosis, low TSH levels, and been treated with a significant dose of methimazole or equivalent. They should be on a stable ATD dose before the study starts.

Inclusion Criteria

I have been taking a specific dose of thyroid medication for the last 4 weeks.

I have been diagnosed with Gaucher's Disease.

I expect to be on a stable dose of my thyroid medication for the next 4 weeks.

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 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 to see if it's effective and safe in treating Graves' disease. The main goal is to check if this new treatment can normalize thyroid hormone levels and reduce the need for current medications by week 26.

How Is the Trial Designed?

Group I: Group 2 Period 1: IMVT-1402 and Period 2: Placebo Experimental Treatment 1 Intervention

Group II: Group 2 Period 1 and 2: IMVT-1402 Experimental Treatment 1 Intervention

Group III: Group 1 Period 1 and 2: IMVT-1402 Experimental Treatment 1 Intervention

Group IV: Group 3 Period 1 and 2: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Immunovant Sciences GmbH

Lead Sponsor

Trials

12

Recruited

1,400+

Citations

1. 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 ...

2. 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 ...

3. denverendocenter.com denverendocenter.com/research-study-opportunities/efficacy-safety-and-tolerability-of-imvt-1402/

Efficacy, Safety, and Tolerability of IMVT 1402 for Graves' ... A Randomized, Double-Blind, Placebo Controlled, Phase 2b Study to Assess the Efficacy, Safety and Tolerability of IMVT-1402 as Treatment for Adult Patients with ...

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. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06727604

IMVT-1402 as Treatment for Adult Participants With Graves' ... 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 ...

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.

7. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-partici

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT ... 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 ...

8. immunovant.com immunovant.com/investors/news-events/press-releases/detail/65/immunovant-provides-update-on-graves-disease-development

Immunovant Provides Update on Graves' Disease ... ... IMVT-1402 in Graves' Disease (GD); Real world claims data indicates 25-30% of Graves' Disease patients per year are uncontrolled on ATDs with ...