Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: YB-101, Placebo YB-101.
- Who it may be relevant to
- Registry conditions: Graves' Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Experimental: YB-101
YB-101 is administered over a 24 week period. - Drug Placebo YB-101
Placebo will be administered over a 24 week period.
Primary outcome measures
- Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) [Time frame: 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 [Time frame: Baseline, Day 169]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 26 centers
- Site 112 — Gilbert
- Site 130 — Phoenix
- Site 121 — La Mesa
- Site 103 — Sacramento
- Site 111 — San Francisco
- Site 105 — Torrance
- Site 109 — Miami Lakes
- Site 115 — Palm Harbor
- … and 18 more centers
Australia · 2 centers
- Site 151 — East Melbourne
- Site 150 — Melbourne N.
Identifiers
NCT: NCT07682896 · YB-101-201