RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Participants with the ability to understand the requirements of the trial, provide written willing to sign a consent form, 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.
Who Should NOT Join This Trial:
- Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
- Have an autoimmune conditions (where your immune system attacks your own body) 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
IMVT-1402
Dose 1 for 26 weeks
DRUG
IMVT-1402
Dose 2 for 26 weeks
DRUG
Placebo
For 26 weeks
Locations (20)
Site Number - 1015
Tucson, Arizona, United States
Site Number -1014
Concord, California, United States
Site Number - 1013
Aurora, Colorado, United States
Site Number - 1024
Doral, Florida, United States
Site Number - 1008
Hialeah, Florida, United States
Site Number - 1000
Miami, Florida, United States
Site Number - 1020
Columbus, Georgia, United States
Site Number - 1022
Topeka, Kansas, United States
Site Number - 1033
Jefferson City, Missouri, United States
Site Number - 1004
Kansas City, Missouri, United States
Site Number - 1019
St Louis, Missouri, United States
Site Number - 1012
Reno, Nevada, United States
Site Number - 1032
Long Island City, New York, United States
Site Number - 1027
New Hyde Park, New York, United States
Site Number - 1009
New York, New York, United States
Site Number - 1018
Williamsville, New York, United States
Site Number - 1010
Chapel Hill, North Carolina, United States
Site Number - 1026
Hickory, North Carolina, United States
Site Number - 1001
Morehead City, North Carolina, United States
Site Number - 1034
Raleigh, North Carolina, United States