Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
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
1 other identifier
interventional
232
2 countries
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2026
Typical duration for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2026
CompletedFirst Submitted
Initial submission to the registry
June 24, 2026
CompletedFirst Posted
Study publicly available on registry
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
July 28, 2026
July 1, 2026
1.5 years
June 24, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Baseline, Day 169
Proportion of participants with normal free triiodothyronine (FT3), free thyroxine (FT4), and thyroid-stimulating hormone (TSH) who discontinued anti-thyroid drugs (ATDs), regardless of concomitant levothyroxine use
Baseline, Day 169
Study Arms (2)
YB-101
EXPERIMENTALIn Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection.
Placebo YB-101
PLACEBO COMPARATORIn Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Site 112
Gilbert, Arizona, 85297, United States
Site 130
Phoenix, Arizona, 85006, United States
Site 121
La Mesa, California, 91942, United States
Site 103
Sacramento, California, 95817, United States
Site 111
San Francisco, California, 94143, United States
Site 105
Torrance, California, 90502, United States
Site 109
Miami Lakes, Florida, 33016, United States
Site 115
Palm Harbor, Florida, 34684, United States
Site 123
Sarasota, Florida, 34239, United States
Site 118
Macon, Georgia, 31210, United States
Site 122
Bowling Green, Kentucky, 42103, United States
Site 126
Flint, Michigan, 48532, United States
Site 107
Livonia, Michigan, 48152, United States
Site 108
Omaha, Nebraska, 68198, United States
Site 129
Niagara Falls, New York, 14304, United States
Site 120
Orchard Park, New York, 14127, United States
Site 124
Sayre, Pennsylvania, 18840, United States
Site 100
Amarillo, Texas, 79124, United States
Site 117
Conroe, Texas, 77384, United States
Site 128
Edinburg, Texas, 78539, United States
Site 127
El Paso, Texas, 79935, United States
Site 106
Fort Worth, Texas, 76132, United States
Site 110
Houston, Texas, 77095, United States
Site 101
Humble, Texas, 77346, United States
Site 116
San Antonio, Texas, 78233, United States
Site 119
Chesapeake, Virginia, 23321, United States
Site 151
East Melbourne, Victoria, 3002, Australia
Site 150
Melbourne N., Victoria, 3051, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2026
First Posted
July 6, 2026
Study Start
June 10, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
September 1, 2029
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share