Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT06727604
Eligibility Criteria:
Inclusion Criteria:
* Have documented diagnosis of GD.
* Have a TSH value \< 0.1 mIU/L as assessed by the local 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 of ≥ 20 mg/day methimazole or equivalent 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 at any point during the participant's treatment history.
* Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent 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.
Additional inclusion criteria are defined in the protocol.
Exclusion Criteria:
* 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.
* 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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06727604
Study Brief:
Protocol Section:
NCT06727604