At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- IMVT-1402 (drug), IMVT-1402 (drug), Placebo (drug)
- How long the study runs
- Study runs about 42 months (dates as stated)
- About the drug or intervention
- IMVT-1402 — drug: 600 mg SC QW for 52 weeks · IMVT-1402 — drug: 600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks · Placebo — drug: SC QW for 52 weeks
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a treatment called IMVT-1402 for adults with Graves' disease, a condition where the immune system makes the thyroid gland overactive. The researchers want to find out how well the treatment works, how safe it is, and how well people cope with it. The study is being run by Immunovant Sciences GmbH.
Who can take part
- Adults aged 18 or over, male or female
- People able to understand the study, give written consent, and follow the study procedures
- People diagnosed with Graves' disease whose thyroid is still overactive despite taking antithyroid drug (ATD) treatment
- Other, more specific entry rules are set out in the study plan
Who may not be able to
- People who have already been successfully treated with radioactive iodine (RAI) therapy, or who have had their thyroid gland fully removed (total thyroidectomy)
- People with another autoimmune disease needing treatment that, in the researcher's view, would put them at too much risk
- People with moderate-to-severe active thyroid eye disease (TED) who are expected to need surgery straight away, or who are planning surgery, irradiation, or medical treatment for it during the study
- Other exclusion rules are set out in the study plan
What taking part involves
- • Taking the study medicine IMVT-1402 — how it is given and how often is not stated — ask the trial team
Time commitment: Number of visits, how long the study lasts, and what taking part involves: not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 240
- Started
- 2024-12-17
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for graves' disease
- • Phase2 - 240 participants
- • 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
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with graves' disease
Where?
- • Birmingham - Site Number - 7013
- • Bristol - Site Number - 7012
- • Coventry - Site Number - 7011
- • London - Site Number - 7007
- • +10 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Participants with the ability to understand the requirements of the trial, provide written agreement to take part, and...
- ✓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...
- ✗Additional exclusion criteria are defined in the protocol.
See the full criteria
Where Is This Study? (14 UK sites)
Site Number - 7013
Birmingham B15 2TT, United Kingdom
Site Number - 7012
Bristol BS10 5NB, United Kingdom
Site Number - 7011
Coventry CV2 2DX, United Kingdom
Site Number - 7007
London NW1 2PG, United Kingdom
Site Number - 7014
Cambridge CB2 0QQ, United Kingdom
Site Number - 7002
Cardiff CF14 4XW, United Kingdom
Site Number - 7008
Edinburgh EH16 4SA, United Kingdom
Site Number - 7005
Huddersfield HD3 3EA, United Kingdom
Site Number - 7004
Hull HU6 7RX, United Kingdom
Site Number - 7003
London SE5 9RS, United Kingdom
Site Number - 7006
Manchester M20 4BX, United Kingdom
Site Number - 7001
Newcastle upon Tyne NE1 4LP, United Kingdom
Site Number - 7009
Norwich NR4 7UY, United Kingdom
Site Number - 7010
Nuneaton CV10 7DJ, United Kingdom
How to Get in Touch
Central Study Contact
Sponsor contactCONTACT