A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants with Graves’ Disease (GD)

Immunovant Sciences GmbH0 个研究点目标入组 45 人开始时间: 2022年11月9日最近更新: 2024年9月2日

研究概览

暂无简介。

•1. Male or female >= 18 years of age.
•2. Have a serologically confirmed GD as documented by presence of elevated stimulatory TSH-R-Ab level (i.e., > SRR 140 %) at the Screening Visit.
•3. Have active hyperthyroidism due to GD with the following laboratory values at the Screening Visit:
•TSH < lower limit of normal (LLN)
•FT3 > upper limit of normal (ULN) and =5× ULN
•FT4 > ULN and =5 × ULN
•Note: Participants who have T3 thyrotoxicosis (i.e., TSH 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.
•4. Meet all of the following ATD requirements at the Screening Visit:
•Have been on an ATD for =12 weeks before the Screening Visit.
•Had starting total daily ATD dose of =20 mg of methimazole or carbimazole, or =200 mg of propylthiouracil.
•Are currently treated with a total daily dose of =10 mg of methimazole or carbimazole, or =100 mg of propylthiouracil.
•5. Other, more specific inclusion criteria are defined in the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm.
•2. History of treatment with radioactive iodine or thyroid surgery.
•Note: Participants may be enrolled if they meet Inclusion Criteria 3 and 4 listed in this summary (numbered as Inclusion Criteria 2 and 3 in the Protocol).
•3. Total IgG level <6 grams per liter (g/L) at the Screening Visit.
•4. Albumin level <3.5 grams per deciliter (g/dL) (<35 g/L) at the Screening Visit.
•5. Absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3) at the Screening Visit.
•6. Have been enrolled in a previous RVT-1401, IMVT-1401 clinical trial.
•Note: Participants previously enrolled in an IMVT-1401 clinical trial, with documented assignment to placebo treatment only, may be enrolled in this study.
•7. Other, more specific exclusion criteria are defined in the protocol.

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