YB-101 injections for adults with Graves' disease, compared with placebo
Tests YB-101 against placebo for safety and thyroid effects in Graves' disease.
Key facts
- Who runs it
- Yarrow Bioscience, Inc.
- Where
- Amarillo, Bowling Green, Cary, Conroe, Dallas, Durham, Edinburg, El Paso, Flint, Fort Worth, Gilbert, Houston, Humble, La Mesa, Livonia, Macon, Miami Lakes, Niagara Falls, Ocoee, Omaha, Orchard Park, Palm Harbor, Phoenix, Sacramento, San Francisco, Sarasota, Sayre, Torrance, and Tucson, United StatesSee the 29 sitesAlso in 1 other country, 3 sites
- Trial code
- Registry title
- Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 232 people, planned
- Started
- 10 Jun 2026
- Expected to end
- Sept 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Experimental: YB-101
- Placebo YB-101
- Record updated
- 30 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Graves' disease, an overactive thyroid caused by the immune system. It tests YB-101 against a placebo (dummy injection).
- Age
- 18 Years and older
- Sex
- All
- Disease stage
- Graves' disease confirmed by thyroid-stimulating hormone receptor antibodies (TRAbs). People can join with a known diagnosis of TED (thyroid eye disease) or with no sign of TED at the screening eye exam.
- Earlier treatment
- People cannot have had radioactive iodine (RAI) therapy or total removal of the thyroid. No levothyroxine, desiccated thyroid extract or T3 within 6 weeks before screening. No teprotumumab now or within 15 weeks before screening.
- Biomarker or test result
- Thyroid-stimulating hormone receptor antibodies (TRAbs) present, from medical history or a screening lab test.
Main reasons for not taking part
- Earlier radioactive iodine (RAI) therapy or total thyroidectomy
- Levothyroxine, desiccated thyroid extract or T3 within 6 weeks before screening
- Teprotumumab now or within 15 weeks before screening
- Overactive thyroid from another cause, such as toxic adenoma or toxic multinodular goiter, within 6 months before screening
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
Also in 1 other country, 3 sites
- Amarillo, TexasHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Bowling Green, KentuckyHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Cary, North CarolinaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Conroe, TexasHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Dallas, TexasHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Durham, North CarolinaHospital not named in the registryContact: Victoria Lacasse, MDNot yet recruiting
- Edinburg, TexasHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- El Paso, TexasHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Flint, MichiganHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Fort Worth, TexasHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Gilbert, ArizonaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Houston, TexasHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Humble, TexasHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- La Mesa, CaliforniaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Livonia, MichiganHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Macon, GeorgiaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Miami Lakes, FloridaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Niagara Falls, New YorkHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Ocoee, FloridaHospital not named in the registryContact: Victoria Lacasse, MDNot yet recruiting
- Omaha, NebraskaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Orchard Park, New YorkHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Palm Harbor, FloridaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Phoenix, ArizonaHospital not named in the registryContact: Victoria Lacasse, MDNot yet recruiting
- Sacramento, CaliforniaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- San Francisco, CaliforniaHospital not named in the registryContact: Victoria Lacasse, MDNot yet recruiting
- Sarasota, FloridaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Sayre, PennsylvaniaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Torrance, CaliforniaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
- Tucson, ArizonaHospital not named in the registryContact: Victoria Lacasse, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- YB-101Treatment being tested
In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection.
Treatment: Experimental: YB-101
- Placebo YB-101Placebo, for comparison
In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Blinded, Placebo-Controlled, Two-Part, Phase 2 Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of YB-101 in Participants With Graves' Disease
- Plain-language title
- YB-101 injections for adults with Graves' disease, compared with placeboGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 30 October 2026