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

Overview

About this study

The purpose of this study is to evaluate the efficacy of IMVT-1402 as treatment for adult patient Graves' Disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Disease-specific

  • Have documented diagnosis of GD by at least one of the following:
    • Thyrotoxicosis with contemporaneous positive thyroid scintigraphy consistent with GD.
    • Thyrotoxicosis with positive TRAb and/or thyroidstimulating immunoglobulin (TSI).
  • Have a TSH value < 0.1 mIU/L as assessed by the local laboratory at the Screening Visit.
  • Have a TRAb value ≥ 3 × ULN as assessed by the central laboratory at the Screening Visit.
  • Meet one of the following at the Screening Visit:
    • Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following:
      • Are on ATD at the Screening Visit with an ATD dose ≥ 20 mg/day methimazole or equivalent (i.e., ≥ 30 mg/day carbimazole, ≥ 200 mg/day propylthiouracil) for the 4-week period immediately preceding the Screening Visit.
      • Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.
    • Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following:
      • Have been treated with ≥ 15 mg/day methimazole or equivalent (i.e., ≥ 20 mg/day carbimazole, ≥ 150 mg/day propylthiouracil) at any point during the participant's treatment history.
      • Are on ATD at the Screening Visit with an ATD dose ≥ 10 mg/day methimazole or equivalent (i.e., ≥ 15 mg/day carbimazole, ≥ 100 mg/day propylthiouracil) for the 4-week period immediately preceding the Screening Visit.
      • Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.

Exclusion Criteria:

Disease-specific

  • Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
  • Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value < lower limit of normal (LLN) as assessed by the local laboratory at the Screening Visit.
  • Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit. Note: Participants receiving block-and-replace treatment are not eligible.
  • Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit.
  • Have 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.
  • Have a documented history of noncompliance with ATD therapy

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/05/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marius Stan, M.D.

Contact us for the latest status

Contact information:

Hamad Gul

(507) 284-5833

Gul.Hamad@mayo.edu

More information

Publications

Publications are currently not available