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
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Site Number -1014
RECRUITING
Concord
Florida
Site Number - 1008
RECRUITING
Hialeah
Site Number - 1000
RECRUITING
Miami
Georgia
Site Number - 1020
RECRUITING
Columbus
North Carolina
Site Number - 1026
RECRUITING
Hickory
Site Number - 1001
RECRUITING
Morehead City
Nevada
Site Number - 1012
RECRUITING
Reno
Texas
Site Number - 1002
RECRUITING
El Paso
Site Number - 1003
RECRUITING
Fort Worth
Site Number - 1011
RECRUITING
San Antonio
Contact Information
Primary
Central Study Contact
clinicaltrials@immunovant.com
18007970414
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2027-05
Participants
Target number of participants: 210
Treatments
Experimental: IMVT-1402 Dose 1
Experimental: IMVT-1402 Dose 2
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Immunovant Sciences GmbH