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A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

Immunovant Sciences GmbH · NCT06727604

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
240
US sites recruiting
55
Study start
December 17, 2024
Record last updated
August 25, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: IMVT-1402; IMVT-1402; Placebo

Conditions: Graves' Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
  • Male or female participants aged ≥ 18 years.
  • Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
  • Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria

  • Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
  • Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
  • Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
  • Additional exclusion criteria are defined in the protocol.

Recruiting US locations

Study contacts (from the official record)

  • Central Study Contact · 18007970414 · clinicaltrials@immunovant.com
A Study to Assess the Efficacy, Safety, and Tolerability of… (NCT06727604) | Bored Studies