NCT06727604

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Graves' Disease

Interventions

Type	Name	Description
DRUG	IMVT-1402	600 mg SC QW for 52 weeks
DRUG	IMVT-1402	600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
DRUG	Placebo	SC QW for 52 weeks

Timeline

• Start date: 2024-12-17
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-12-11
• Last updated: 2026-04-13

Locations

130 sites across 10 countries: United States, Belgium, Georgia, Germany, Hungary, Italy, Poland, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study