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Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease

RecruitingPhase 2Ages 18 Years - anyAllYarrow Bioscience, Inc.
NCT07682896 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is being conducted to look at the effect YB-101 has on thyroid function. This study will also evaluate how safe and well tolerated YB-101 is and how it is distributed through the body. The study consists of a part 1, blinded treatment period, and a part 2 double-blinded treatment period. Participants will receive YB-101 or Placebo subcutaneously. Participants who participate in Part 1 can not participate in Part 2. Participants will complete 34-39 in-clinic visits in Part 1 or Part 2 over an approximate 40 week period.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Have a documented diagnosis of Graves' Disease confirmed by the presence of thyroid-stimulating hormone receptor antibodies (TRAbs) by medical history or screening laboratory assessment * Have a pre-existing diagnosis of TED or, conversely, no evidence of TED at the ophthalmological examination performed during screening * Additional inclusion criteria are defined in the protocol Exclusion Criteria: * Previously treated with radioactive iodine (RAI) therapy or underwent total thyroidectomy * Received any dose of levothyroxine, desiccated thyroid extract, or T3 within 6 weeks before screening * Current treatment with teprotumumab or exposure to teprotumumab within 15 weeks prior to screening * History of hyperthyroidism not caused by Graves' disease (eg. toxic adenoma, or toxic multinodular goiter) within 6 months before the screening visit * Pregnant or lactating women * Additional exclusion criteria are defined in the protocol
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What it tests

  • Experimental: YB-101
  • Placebo YB-101
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Where

29 sites
Site 112
Gilbert, United States
Site 130
Phoenix, United States
Site 132
Tucson, United States
Site 121
La Mesa, United States
Site 103
Sacramento, United States
Site 111
San Francisco, United States
Site 105
Torrance, United States
Site 109
Miami Lakes, United States

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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