Not currently recruiting at University of California Health

Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease

a study on Graves' Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

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.

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

Keywords

Graves' Disease, Graves', Hyperthyroidism, Autoimmune thyroid disease, TSH receptor antibodies, Graves Disease, Experimental: YB-101

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join 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
  • Additional exclusion criteria are defined in the protocol

Locations

  • Site 111 not yet accepting patients
    San Francisco California 94143 United States
  • Site 125 not yet accepting patients
    Orange California 92868 United States
  • Site 121 not yet accepting patients
    La Mesa California 91942 United States
  • Site 103 not yet accepting patients
    Sacramento California 95817 United States
  • Site 105 not yet accepting patients
    Torrance California 90502 United States
  • Site 100 accepting new patients
    Amarillo Texas 79124 United States
  • Site 117 accepting new patients
    Conroe Texas 77384 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Yarrow Bioscience, Inc.
ID
NCT07682896
Phase
Phase 2 Graves' Disease Research Study
Study Type
Interventional
Participants
Expecting 232 study participants
Last Updated