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

Immunovant

Status and phase: Enrolling; Phase 2

Conditions: Graves' Disease

Treatments: Drug: IMVT-1402; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06727604

2024-516020-33-00 (EU Trial (CTIS) Number)

IMVT-1402-2502

Details and patient eligibility

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.

Enrollment: 240 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 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups, including a placebo group

Group 1 Period 1 and 2: IMVT-1402

Experimental group

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

Group 2 Period 1 and 2: IMVT-1402

Experimental group

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

Group 2 Period 1: IMVT-1402 and Period 2: Placebo

Experimental group

Treatment:

Drug: IMVT-1402

Drug: IMVT-1402

Group 3 Period 1 and 2: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo