IMVT-1402 for adults with Graves' disease who remain hyperthyroid on medicine
Tests IMVT-1402 against placebo in adults with Graves' disease still hyperthyroid on treatment.
Key facts
- Who runs it
- Immunovant Sciences GmbH
- Where
- Birmingham, Bristol, Cambridge, Cardiff, Coventry, Edinburgh, Huddersfield, Hull, London, Manchester, Newcastle upon Tyne, Norwich, and Nuneaton, United KingdomSee the 14 sitesAlso in 9 other countries, 119 sites
- Trial code
- Registry title
- A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 240 people, planned
- Started
- 17 Dec 2024
- Expected to end
- Jun 2028
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- IMVT-1402
- Placebo
- Record updated
- 25 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Graves' disease whose thyroid is still overactive despite antithyroid drug (ATD) treatment. It tests IMVT-1402 against a placebo (dummy drug).
- Age
- 18 to 75 years
- Sex
- Men and women
- Disease stage
- Graves' disease with an overactive thyroid (hyperthyroid) despite antithyroid drug treatment.
- Earlier treatment
- Must be taking or have taken antithyroid drug (ATD) treatment. People who were successfully treated with radioactive iodine or had the whole thyroid removed cannot join.
Main reasons for not taking part
- Earlier successful radioactive iodine (RAI) treatment
- Surgery that removed the whole thyroid
- Another autoimmune disease needing treatment that the doctor thinks puts you at too much risk
- Moderate-to-severe active thyroid eye disease needing quick surgery, or planned surgery, radiation or drug treatment for it during the trial
- Other reasons set out in the protocol
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United Kingdom
Also in 9 other countries, 119 sites
- Birmingham, EnglandHospital not named in the registryTaking people
- Bristol, EnglandHospital not named in the registryTaking people
- Cambridge, LondonHospital not named in the registryTaking people
- CardiffHospital not named in the registryTaking people
- Coventry, EnglandHospital not named in the registryTaking people
- EdinburghHospital not named in the registryTaking people
- HuddersfieldHospital not named in the registryTaking people
- HullHospital not named in the registryTaking people
- London, EnglandHospital not named in the registryTaking people
- LondonHospital not named in the registryTaking people
- ManchesterHospital not named in the registryTaking people
- Newcastle upon TyneHospital not named in the registryTaking people
- NorwichHospital not named in the registryTaking people
- NuneatonHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- Group 1 Period 1 and 2: IMVT-1402Treatment being tested
Treatment: IMVT-1402
- Group 2 Period 1 and 2: IMVT-1402Treatment being tested
Treatment: IMVT-1402
- Group 2 Period 1: IMVT-1402 and Period 2: PlaceboTreatment being tested
Treatment: IMVT-1402
- Group 3 Period 1 and 2: PlaceboPlacebo, for comparison
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official 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
- Plain-language title
- IMVT-1402 for adults with Graves' disease who remain hyperthyroid on medicineGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06727604, who can take part
- Record updated
- 25 August 2026