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Taking peoplePhase 2

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

Key facts

Who runs it
Immunovant Sciences GmbH
Where
Bologna, Cagliari, Genoa, Milan, Naples, Pisa, Rome, Siena, and Varese, ItalySee the 11 sitesAlso in 9 other countries, 122 sites
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

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

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 Italy

Also in 9 other countries, 122 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaBologna, ItalyNo longer taking part
  • Azienda Ospedaliero - Universitaria di CagliariCagliari, ItalyNo longer taking part
  • IRCCS Ospedale Policlinico San MartinoGenoa, ItalyNo longer taking part
  • ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyNo longer taking part
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNo longer taking part
  • Istituto Auxologico ItalianoMilan, ItalyNo longer taking part
  • Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyNo longer taking part
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyNo longer taking part
  • Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyNo longer taking part
  • Azienda Ospedaliera Universitaria SeneseSiena, ItalyNo longer taking part
  • Azienda Ospedaliera Ospedale Di Circolo E Fondazione MacchiVarese, ItalyNo longer taking part

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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
Fit questions
Built from NCT06727604, who can take part
Record updated
25 August 2026