A Phase 2b Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Graves' Disease
Research type
Research Study
Full title
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
IRAS ID
1012210
Contact name
Valerie Goguen
Contact email
Sponsor organisation
Immunovant Sciences GmbH
Research summary
The thyroid is a small gland in the neck that helps control multiple bodily functions including energy levels and
metabolism. Graves’ disease is an autoimmune condition that makes the thyroid work harder than it should. Symptoms of Graves’ disease can include a fast heartbeat, unexpected weight loss, and anxiety. With Graves’ disease, the body makes harmful antibodies. These harmful antibodies cause the thyroid gland to make too many thyroid hormones. Although current medications can stop the thyroid from making too many thyroid hormones, they do not help to remove the harmful antibodies.
This study will test a new treatment called IMVT-1402, and test how well it works for Graves’ disease compared to a placebo (a look-alike substance that does not have IMVT-1402 in it).
Researches will also measure:
- Thyroid function;
- Dose of other Graves’ disease medication needed;
- Harmful autoantibody levels;
- How participants feel;
- Safety.This study has 3 parts:
-Screening Period: Researchers will check if potential participants can enter the study.
-Treatment Period: Participants will take either IMVT-1402 or placebo. All participants will take their Graves’ disease medications that are allowed in the study.
- Follow-up Period: Participants will not take any study treatment and be followed for any side effect for 4 weeks.Participants will be in one of the following treatment groups for 26 weeks:
- Group 1: Participants will take IMVT-1402 Dose 1.
- Group 2: Participants will take IMVT-1402 Dose 2.
- Group 3: Participants will take placebo
Participants will not know if they are getting IMVT-1402 or placebo. The researchers will not know either.
During the Treatment Period, participants will receive weekly injections of IMVT-1402 or placebo, given under the skin using an autoinjector. Each dose requires 2 injections, once a week, given one right after the other.Participants will be in this study for up to 35 weeks total.
REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0487
Date of REC Opinion
31 Jul 2025
REC opinion
Further Information Favourable Opinion