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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorImmunovant Sciences GmbH

About this trial

This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • IMVT-1402
  • IMVT-1402
  • Placebo

Treatment groups

210 Participants
are divided into 3 treatment groups

Sponsors and collaborators