Actively Recruiting
Phase 2 Evaluation of YB-101 Compared to Placebo for Safety and Effectiveness in Adults with Graves Disease
Led by Yarrow Bioscience, Inc. · Updated on 2026-07-28
232
Participants Needed
28
Research Sites
91 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of YB-101 on thyroid function in adults with Graves Disease. The study aims to assess how safe and well tolerated YB-101 is, as well as how it is distributed in the body. This Phase 2 trial includes participants with a documented diagnosis of Graves Disease confirmed by thyroid-stimulating hormone receptor antibodies. The study has two parts Part 1 is a blinded treatment period and Part 2 is a double-blinded treatment period. Participants will receive either YB-101 or a placebo through subcutaneous injections over a 24-week period. Those who participate in Part 1 are not eligible to participate in Part 2. The treatments and placebo are administered similarly in both parts. Participants will attend between 34 to 39 in-clinic visits over approximately 40 weeks depending on their assigned part. Researchers will monitor side effects, safety, and thyroid hormone levels including free triiodothyronine FT3, free thyroxine FT4, and thyroid-stimulating hormone TSH. They will also evaluate the proportion of participants who normalize these hormones and stop anti-thyroid drugs. The study includes safety assessments up to Day 169 and ongoing monitoring throughout the treatment period.
CONDITIONS
Brief Title
Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
Research Team
V
Victoria Lacasse, MD
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