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
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Site 112
RECRUITING
Gilbert
Site 130
NOT_YET_RECRUITING
Phoenix
Clinical Research Site
NOT_YET_RECRUITING
Tucson
California
Site 121
RECRUITING
La Mesa
Site 103
NOT_YET_RECRUITING
Sacramento
Site 111
NOT_YET_RECRUITING
San Francisco
Site 105
NOT_YET_RECRUITING
Torrance
Florida
Site 109
RECRUITING
Miami Lakes
Site 115
RECRUITING
Palm Harbor
Site 123
NOT_YET_RECRUITING
Sarasota
Georgia
Site 118
RECRUITING
Macon
Kentucky
Site 122
RECRUITING
Bowling Green
Michigan
Site 126
RECRUITING
Flint
Site 107
RECRUITING
Livonia
North Carolina
Clinical Research Site
NOT_YET_RECRUITING
Raleigh
Nebraska
Site 108
NOT_YET_RECRUITING
Omaha
New York
Site 129
RECRUITING
Niagara Falls
Site 120
RECRUITING
Orchard Park
Pennsylvania
Site 124
NOT_YET_RECRUITING
Sayre
Texas
Site 100
RECRUITING
Amarillo
Site 117
RECRUITING
Conroe
Clinical Research Site
NOT_YET_RECRUITING
Dallas
Site 128
RECRUITING
Edinburg
Site 127
NOT_YET_RECRUITING
El Paso
Site 106
RECRUITING
Fort Worth
Site 110
RECRUITING
Houston
Site 101
RECRUITING
Humble
Site 116
RECRUITING
San Antonio
Other Locations
Australia
Site 151
NOT_YET_RECRUITING
East Melbourne
Site 150
NOT_YET_RECRUITING
Melbourne N.
Contact Information
Primary
Victoria Lacasse, MD
VL@YarrowBioscience.com
469-278-6161
Time Frame
Start Date:2026-06-10
Estimated Completion Date:2029-09
Participants
Target number of participants:232
Treatments
Experimental: YB-101
In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection.
Placebo_comparator: Placebo YB-101
In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.