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 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT05907668
Eligibility Criteria:
Inclusion Criteria:
* Have serologically confirmed GD as documented by presence of elevated stimulatory thyrotropin receptor antibody (TSH-R-Ab) level (i.e., \> specimen-to-reference ratio of 140%) at the Screening Visit.
* Have active hyperthyroidism due to GD with the following laboratory values at the Screening Visit:
* TSH \< LLN
* FT3 \> upper limit of normal (ULN) and \<=5 \* ULN
* FT4 \> ULN and \<=5 \* ULN
Note: Participants who have T3 thyrotoxicosis (i.e TSH \<LLN, FT3 \> ULN and ≤5× ULN, but FT4 within normal range) at the Screening Visit may be enrolled, if they have serologically confirmed GD as per Inclusion Criterion 1.
* Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule.
Exclusion Criteria:
* History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm.
* History of treatment with radioactive iodine or thyroid surgery.
* Total immunoglobulin G (IgG) level \<6 grams per liter (g/L) at the Screening Visit.
* Albumin level \<3.5 grams per deciliter (g/dL) (\<35 g/L) at the Screening Visit.
* Absolute neutrophil count \<1000 cells per cubic millimeter (cells/mm\^3) at the Screening Visit.
Other, more specific exclusion criteria are defined in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05907668
Study Brief:
Protocol Section:
NCT05907668