A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease

NCT05424276 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IkT-148009-201
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 28

Brief Summary

This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com

Conditions

Parkinson Disease

Keywords

Untreated Parkinsons disease

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-emergent Adverse Events (TEAEs)

  Baseline to 12 weeks

• Proportion of Those Randomized in Each Dosing Cohort Who Discontinued the Assigned Regimen Due to an Adverse Event

  Baseline to 12 weeks

Secondary Outcomes (14)

• LS Mean of Change From Baseline in MDS-UPDRS Part II+III From a Mixed Model for Repeated Measures

  Baseline to Week 12

• LS Mean of Change From Baseline in PDQ-39 From a Mixed Model for Repeated Measures

  Change from Baseline to Week 12

• LS Mean of Change From Baseline in PGI-S From a Mixed Model for Repeated Measures

  Change from Baseline to Week 12

• LS Mean of Change From Baseline in CGI-S From a Mixed Model for Repeated Measures

  Change from Baseline to Week 12

• LS Mean of Change From Baseline in MDS-UPDRS Part II From a Mixed Model for Repeated Measures

  Baseline to 12 weeks

Study Arms (4)

50mg IkT-148009 (risvodetinib)

EXPERIMENTAL

This arm consisted of participants treated with the 50mg dose of risvodetinib.

Drug: IkT-148009 (risvodetinib)

100mg IkT-148009 (risvodetinib)

EXPERIMENTAL

This arm consisted of participants treated with the 100mg dose of risvodetinib.

Drug: IkT-148009 (risvodetinib)

200mg IkT-148009 (risvodetinib)

EXPERIMENTAL

This arm consisted of participants treated with the 200mg dose of risvodetinib.

Drug: IkT-148009 (risvodetinib)

Placebo

PLACEBO COMPARATOR

This arm consisted of participants treated with placebo.

Drug: Placebo

Interventions

IkT-148009 (risvodetinib) DRUG

Oral administration gelatin capsule

100mg IkT-148009 (risvodetinib); 200mg IkT-148009 (risvodetinib); 50mg IkT-148009 (risvodetinib)

Placebo DRUG

Oral administration gelatin capsule

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are diagnosed with PD consistent with UK Brain Bank criteria and MDS Research Criteria; must include bradykinesia with sequence effect and motor asymmetry.
• Receiving no anti-parkinsonian therapy
• Modified Hoehn/Yahr Stage \< 3.0
• Montreal Cognitive Assessment ≥ 24
• Patient expected to be able to participate in trial without need for additional anti-parkinsonian therapy
• Sex and Contraceptive/Barrier Requirements:
• Male participants must agree to practice an acceptable method of highly effective birth control from the screening visit, while on study and for 30 days after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence, vasectomy, or a condom with spermicide (men) in combination with their partner's highly effective method.
• Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and at least 30 days after the last dose of study drug has been taken.
• Informed Consent:
• \. Capable of giving signed ICF as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• \. Approved as an appropriate and suitable candidate by the EAC.

You may not qualify if:

• Diagnosis/suspicion of secondary or atypical parkinsonism
• Previous procedure or surgery for PD, or anticipation of these during the study
• High likelihood of needing anti-parkinsonian treatment over the study period, in the opinion of the investigator
• Clinically significant orthostatic hypotension
• Clinically significant hallucinations requiring antipsychotic use in the 12 months prior to Screening
• Clinically significant medical, surgical, psychiatric, or laboratory abnormalities in the judgement of the treating investigator or the EAC
• Prior/Concomitant Therapy:
• Past treatment with levodopa, dopaminergic agonists, monoamine oxidase-B inhibitors, supplements containing levodopa (i.e. Mucana pruriens), or A2A antagonists for more than 28 days, or treatment with any of these medications or supplements within 28 days prior to screening
• Past treatment with irreversible monoamine oxidase-B inhibitors (e.g., selegiline) for more than 28 days; must be discontinued for at least 90 days before screening
• Currently receiving moderate or strong Cytochrome P450 (CYP) 3A4/5 inducers or CYP3A4/5 inhibitors (except for topical administration)
• Currently receiving any antipsychotic, metoclopramide, reserpine, or amphetamine.
• Prior/Concurrent Clinical Study Experience:
• Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days prior to screening
• Previous randomization into this or another IkT-148009 study
• Diagnostic Assessments:

Sponsors & Collaborators

• ABLi Therapeutics, Inc.: lead

Study Sites (28)

Neurology

Scottsdale, Arizona, 85258, United States

Location

Neurology

Little Rock, Arkansas, 72205, United States

Location

Neurology

Reseda, California, 91335, United States

Location

Neurology

Stamford, Connecticut, 06905, United States

Location

Neurologist

Boca Raton, Florida, 33486, United States

Location

Neurology

Miami, Florida, 33136, United States

Location

Neurology

Naples, Florida, 34105, United States

Location

Neurology

Tampa, Florida, 33609, United States

Location

Neurology

Tampa, Florida, 33613, United States

Location

Neurology

Foxborough, Massachusetts, 02035, United States

Location

Neurology

South Dartmouth, Massachusetts, 02747, United States

Location

Neurology

Farmington Hills, Michigan, 48334, United States

Location

Neurology

Golden Valley, Minnesota, 55427, United States

Location

Neurology

West Long Branch, New Jersey, 07764, United States

Location

Neurology

Durham, North Carolina, 27705, United States

Location

Neurology

Raleigh, North Carolina, 27607, United States

Location

Neurology

Columbus, Ohio, 43221, United States

Location

Neurology

Tulsa, Oklahoma, 74136, United States

Location

Neurology

Portland, Oregon, 97239, United States

Location

Neurology

Port Royal, South Carolina, 29935, United States

Location

Neurology

Memphis, Tennessee, 38137, United States

Location

Neurology

Nashville, Tennessee, 37232, United States

Location

Neurology

Frisco, Texas, 75035, United States

Location

Neurology

Houston, Texas, 77030, United States

Location

Neurology

Round Rock, Texas, 78681, United States

Location

Neurology

Kirkland, Washington, 98034, United States

Location

Neurology

Madison, Wisconsin, 53705, United States

Location

Neurology

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Milton Werner
• Organization: ABLi Therapeutics

info@ablitherapeutics.com

9174940831

Study Officials

• Milton Werner, PhD

  ABLi Therapeutics, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: May 15, 2023
• Primary Completion: October 25, 2024
• Study Completion: September 13, 2025
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: End of study

Locations

US (28)