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

Phase 2

Recruiting

• Conditions: Graves' Disease
• Interventions: Drug: IMVT-1402; Drug: Placebo

• Registration Number: NCT07018323
• Lead Sponsor: Immunovant Sciences GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-06-04
• Study First Posted: 2025-06-12
• Study Start: 2025-06-19
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-28
• Primary Completion: 2027-05
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMVT-1402 Dose 2	IMVT-1402	-
IMVT-1402 Dose 1	IMVT-1402	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)	Week 26

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)	Week 26
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)	Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2)	Week 26
Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)	Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)	Baseline, Week 4
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)	Baseline, Week 2
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)	Baseline, Week 4
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)	Baseline, Week 2
Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)	Week 26

Trial Locations

Locations (5)

Site Number - 1008; 🇺🇸 Hialeah, Florida, United States

Site Number - 1000; 🇺🇸 Miami, Florida, United States

Site Number - 1001; 🇺🇸 Morehead City, North Carolina, United States

Site Number - 1002; 🇺🇸 El Paso, Texas, United States

Site Number - 1003; 🇺🇸 Fort Worth, Texas, United States