A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy

NCT ID: NCT06848231

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2026-12-31

Brief Summary

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This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ya-101 in subjects with multiple system atrophy.

Detailed Description

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The purpose of the study is to evaluate 2 doses of YA-101 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) potential efficacy of YA-101.

Conditions

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Multiple System Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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YA-101

Group Type EXPERIMENTAL

YA-101

Intervention Type DRUG

Drug: YA-101

• YA-101 taken BID

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo taken BID

Interventions

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YA-101

Drug: YA-101

• YA-101 taken BID

Intervention Type DRUG

Placebo

Placebo taken BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Able to understand the process of the clinical trial and give informed consent for the participation of the study.
2. Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
3. Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
4. Able to take oral medications.
5. Able to ambulate without the assistance of another person.

Exclusion Criteria

1. Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1.
2. Evidence of renal impairment or hepatic impairment.
3. Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
4. Medical history includes severe systemic diseases such as cardiopulmonary failure, severe liver or kidney disease, and uncontrolled diabetes; significant central nervous system disorders like stroke, encephalitis, and epilepsy and severe head trauma; peptic ulcer in one year prior to screening.
5. Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yoda Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCLA Health

Los Angeles, California, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Columbia University Irving medical center

New York, New York, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status RECRUITING

Juntendo University Hospital

Tokyo, , Japan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital Cancer Center

Taipei, , Taiwan

Site Status NOT_YET_RECRUITING

Countries

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United States Japan Taiwan

Central Contacts

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Email contact via Yoda Therapeutics Inc.

Role: CONTACT

857-468-9328

Facility Contacts

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Westley Ulit

Role: primary

310-206-8153

Anvi Surapaneni

Role: primary

Nadia Amokrane

Role: primary

347-882-4315

Maeve Curtin

Role: primary

Rory Mahabir

Role: primary

713-798-5989

Role: primary

Other Identifiers

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YA-101-201

Identifier Type: -

Identifier Source: org_study_id

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