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

Immunovant

Status and phase: Begins enrollment this month; Phase 2

Conditions: Graves' Disease

Treatments: Drug: IMVT-1402; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07018323

2025-521920-31-00 (EU Trial (CTIS) Number)

IMVT-1402-2503

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups, including a placebo group

IMVT-1402 Dose 1

Experimental group

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

IMVT-1402 Dose 2

Experimental group

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo