YB-101 for Graves' Disease: safety, dosing, and how it works

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial is a Phase 2, randomized, blinded study of subcutaneous YB-101 compared with placebo in participants with Graves' disease. It has two parts: a blinded treatment period in which participants receive either YB-101 or placebo, followed by a second blinded period; participation in Part 1 does not continue into Part 2. The study will assess safety, tolerability, pharmacokinetics, and preliminary efficacy, with frequent in-clinic visits to monitor thyroid function and related measures. Eligible participants may have thyroid eye disease or no evidence of it at screening, and prior treatments like radioactive iodine or thyroid surgery are disqualifying. Lead sponsor is Yarrow Bioscience, with three sites in Arizona recruiting locally.

Why it matters

Who can join: the full rules

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

Where it's running

• Site 112
  Gilbert, Arizona, United States Recruiting
• Site 132
  Tucson, Arizona, United States Recruiting
• Site 121
  La Mesa, California, United States Recruiting
• Site 103
  Sacramento, California, United States Recruiting
• Site 105
  Torrance, California, United States Recruiting
• Site 109
  Miami Lakes, Florida, United States Recruiting

Study contacts

• Study coordinator: Victoria Lacasse, MD
• Email: VL@YarrowBioscience.com
• Phone: 469-278-6161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.