NCT07018323

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: 210 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graves' Disease

Interventions

Type	Name	Description
DRUG	IMVT-1402	Dose 1 for 26 weeks
DRUG	IMVT-1402	Dose 2 for 26 weeks
DRUG	Placebo	For 26 weeks

Timeline

• Start date: 2025-06-19
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-06-12
• Last updated: 2026-04-09

Locations

116 sites across 14 countries: United States, Australia, Bulgaria, Czechia, Georgia, Greece, Israel, Italy, Latvia, Netherlands, New Zealand, Poland, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study