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NCT Number: NCT06727604

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

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.

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Key information

Conditions

Graves' Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Number - 5303, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMVT-1402

Drug

600 mg SC QW for 52 weeks

Placebo

Drug

SC QW for 52 weeks

Primary outcomes

  1. Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26

    Time frame: Week 26

Secondary outcomes

  1. Percentage of participants who are euthyroid and off ATD at Week 52

    Time frame: Week 52

  2. Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52

    Time frame: Week 52

  3. Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78

    Time frame: Week 78

  4. Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104

    Time frame: Week 104

  5. Percentage of participants who have a TRAb value a specified amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52

    Time frame: Week 52

  6. Percentage of participants who have a TRAb value a specific amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78

    Time frame: Week 78

  7. Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline

    Time frame: Week 2

  8. Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline

    Time frame: Week 4

  9. Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26

    Time frame: Week 26

  10. Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26

    Time frame: Week 26

  11. Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52

    Time frame: Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Central Study Contact

CONTACT

[email protected]

18007970414

Sponsors and collaborators

Lead sponsor

Immunovant Sciences GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 11, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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