IMVT-1402 for Graves' Disease

Recruiting at6 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Trial Summary

What is the purpose of this trial?

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 antithyroid drug (ATD) treatment. The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \[T3\] or free triiodothyronine \[FT3\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

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.

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• IMVT-1402 (Monoclonal Antibodies)

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.

Participant Groups

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+