A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
Graves Disease
About this trial
This is an interventional treatment trial for Graves Disease focused on measuring Graves' Disease, IMVT-1401, Batoclimab, Hyperthyroidism
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.
Sites / Locations
- Site Number - 6505Recruiting
Arms of the Study
Arm 1
Experimental
Batoclimab
Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks.