Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
ConditionGraves' Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYarrow Bioscience, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental: YB-101
DrugYB-101 is administered over a 24 week period.
Placebo YB-101
DrugPlacebo will be administered over a 24 week period.
Treatment groups
232 Participants
are divided into 2 treatment groupsGroup A: YB-101Experimental treatment 1 intervention
Group B: Placebo YB-101Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Type and frequency of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time frame
Baseline, Day 1692
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 169Sponsors and contacts
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Source ClinicalTrials.gov