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

Yarrow Bioscience, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Graves' Disease

Treatments: Drug: Experimental: YB-101; Drug: Placebo YB-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT07682896

YB-101-201

Details and patient eligibility

About

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.

Enrollment: 232 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 2 patient groups, including a placebo group

YB-101

Experimental group

Description:

In Part 1, participants will receive YB-101 via subcutaneous injection. Part 2 participants will receive YB-101 via subcutaneous injection.

Treatment:

Drug: Experimental: YB-101

Placebo YB-101

Placebo Comparator group

Description:

In Part 1, participants will receive placebo via subcutaneous injection. Part 2 participants will receive placebo via subcutaneous injection.

Treatment:

Drug: Placebo YB-101