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Parkinson DiseasePhase 2NCT05424276

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

A Phase 2 study testing IkT-148009 (risvodetinib) in people with Parkinson Disease, run by ABLi Therapeutics, Inc. at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
IkT-148009 (risvodetinib)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
137 participants
Where
28 sitesUnited States
Study dates
15 May 2023to 13 Sep 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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:
  • 1. 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.
  • Other Inclusions:
  • 1. Approved as an appropriate and suitable candidate by the EAC.

Who cannot join

  • 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
Show all 27Show fewer
  • 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:
  • Active suicidal ideation within one year prior to screening visit, as determined by the Columbia Suicide Rating Scale (answer of "yes" on question 4 or 5)
  • Current diagnosis or history of substance abuse (excluding nicotine or caffeine) by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
  • Medical or recreational use of marijuana in the 3 months prior to the screening visit
  • Any social or behavioral reason that would preclude completion of the study, in the judgement of the investigator
  • Any skin condition that would interfere with obtaining adequate samples
  • Evidence of advanced, age-related macular degeneration (neovascular or geographic atrophy) or intermediate macular degeneration as defined by Beckman classification (Large drusen > 125 um and/or any AMD pigmentary abnormalities). Evidence of retina/choroid neovascularization from any cause. Evidence of central serous retinopathy.
  • Abnormal amylase and/or lipase at screening (may be repeated during screening period)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN)
  • Significant renal impairment as determined by the following criteria:
  • Creatinine clearance (CrCL) less than or equal to 60 mL/min for subjects < 65 years of age
  • Creatine clearance (CrCL) greater than or equal to 55 mL/min and the absence of proteinuria or hematuria for subjects ≥ 65 years of age
  • Currently lactating, pregnant or planning on becoming pregnant during the study

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Neurologist

    Boca Raton, Florida, 33486

  • Neurology

    Columbus, Ohio, 43221

  • Neurology

    Durham, North Carolina, 27705

  • Neurology

    Farmington Hills, Michigan, 48334

  • Neurology

    Foxborough, Massachusetts, 02035

  • Neurology

    Frisco, Texas, 75035

  • Neurology

    Golden Valley, Minnesota, 55427

  • Neurology

    Houston, Texas, 77030

  • Neurology

    Kirkland, Washington, 98034

  • Neurology

    Little Rock, Arkansas, 72205

  • Neurology

    Madison, Wisconsin, 53705

  • Neurology

    Memphis, Tennessee, 38137

  • Neurology

    Miami, Florida, 33136

  • Neurology

    Milwaukee, Wisconsin, 53226

  • Neurology

    Naples, Florida, 34105

  • Neurology

    Nashville, Tennessee, 37232

  • Neurology

    Port Royal, South Carolina, 29935

  • Neurology

    Portland, Oregon, 97239

  • Neurology

    Raleigh, North Carolina, 27607

  • Neurology

    Reseda, California, 91335

  • Neurology

    Round Rock, Texas, 78681

  • Neurology

    Scottsdale, Arizona, 85258

  • Neurology

    South Dartmouth, Massachusetts, 02747

  • Neurology

    Stamford, Connecticut, 06905

  • Neurology

    Tampa, Florida, 33609

  • Neurology

    Tampa, Florida, 33613

  • Neurology

    Tulsa, Oklahoma, 74136

  • Neurology

    West Long Branch, New Jersey, 07764

Other trials in United States

About this study

Official title: A Phase 2 Study of IkT-148009 in Untreated Parkinson's Disease

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

Read the detailed description

This is a 12-Week, randomized, double-blind, multi-center, placebo-controlled dose-ranging clinical trial of three IkT 148009 doses in patients with untreated PD designed to assess safety, tolerability, and pharmacokinetics of IkT-148009, an oral, once daily c-Abl tyrosine kinase inhibitor. Secondary and exploratory assessments will evaluate the effect of IkT-148009 on motor and non-motor features of the disease. 120 participants are anticipated to be enrolled at up to 34 sites across the US.

Participants will undergo screening to evaluate their eligibility to participate in the study to include evaluation of Parkinson's diagnosis, vital signs, blood chemistry, hematology and urinalysis and complete listing of concomitant medications. An Enrollment Authorization Committee (EAC) will be responsible for reviewing screening data and confirming the eligibility and suitability of participants. Those selected will be enrolled and randomized to one of three active IkT-148009 arms (50/100/200 mg) or a placebo arm (1:1:1:1). All clinical staff, study investigators, and participants will be blinded to study assignments throughout the trial.

A Data Safety Monitoring Committee (DSMB) will evaluate all available safety, tolerability, and PK and Parkinson's disease-related data for each cohort on a monthly to quarterly basis. Adverse event reporting will be evaluated in real-time.

Being tested
IkT-148009 (risvodetinib), Placebo
Keywords
Untreated Parkinsons disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IkT-148009 (risvodetinib)Drug

    Oral administration gelatin capsule

  • PlaceboDrug

    Oral administration gelatin capsule

Study groups in NCT05424276
Study groupRoleWhat they receive
50mg IkT-148009 (risvodetinib)ExperimentalThis arm consisted of participants treated with the 50mg dose of risvodetinib.
Receives: Drug: IkT-148009 (risvodetinib)
100mg IkT-148009 (risvodetinib)ExperimentalThis arm consisted of participants treated with the 100mg dose of risvodetinib.
Receives: Drug: IkT-148009 (risvodetinib)
200mg IkT-148009 (risvodetinib)ExperimentalThis arm consisted of participants treated with the 200mg dose of risvodetinib.
Receives: Drug: IkT-148009 (risvodetinib)
PlaceboPlacebo comparatorThis arm consisted of participants treated with placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-emergent Adverse Events (TEAEs)

    Measured: Baseline to 12 weeks

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

    Measured: Baseline to 12 weeks

Secondary outcomes (14)

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

    Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Parts II and III reflect assessments covering activites of daily living as reported by the participant (Part II) as well as a clinicians assessment of motor abilities (Part III). Part II consists of 13 items with total scores ranging from 0 to 52 while Part III consists of 18 items with total scores range from 0 to 132. Each item is scored 0 (normal) to 4 (severe). The sum of Parts 2 and 3 have a score range of 0 to 184 (31 total items). An increase in sum of Parts 2 and 3 relative to baseline represents a worsening of the participant's Parkinson's disease

    Measured: Baseline to Week 12

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

    Parkinson's Disease Questionnaire (PDQ) consists of 39 questions evaluating activities of daily living. Participants rate each question on a 5 point scale (0 to 4), . The PDQ-39 score ranges from 0 to 100 with higher score representing more advanced disease.

    Measured: Change from Baseline to Week 12

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

    Patient Global Impression - Severity (PGI-S) is participant reported assessment designed to evaluate the severity of their Parkinson's Disease. Scores range from 1 to 4 with 1 considered Normal and 4 considered Severe.

    Measured: Change from Baseline to Week 12

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

    Clinician Global Impression - Severity (CGI-S) is clinician reported assessment designed to evaluate the severity of a participants Parkinson's disease. Scores range from 1 to 7 with 1 considered "Normal" and 7 considered "Among the most extremely ill patients".

    Measured: Change from Baseline to Week 12

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

    Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part II assesses activities of daily living as reported by the participant. Part II consists of 13 items with a total score ranging from 0 to 52. Each item is scored 0 (normal) to 4 (severe). Higher scores reflect increased severity of disease.

    Measured: Baseline to 12 weeks

  6. LS Mean of Change From Baseline in MDS-UPDRS Part III From a Mixed Model for Repeated Measures

    Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part III is completed by clinician and assesses a participants motor function. Part III consists of 18 items with a total score ranging from 0 to 132. Each item is scored 0 (normal) to 4 (severe). Higher scores reflect increased severity of disease.

    Measured: Baseline to 12 weeks

  7. LS Mean of Change From Baseline in MDS-UPDRS Part I From a Mixed Model for Repeated Measures

    Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part I assesses non-motor experiences of daily living. Part I is made up of two section with one rated by the investigator and another completed by the participant. Part I consists of 13 items with a total score ranging from 0 to 52. Each item is scored 0 (normal) to 4 (severe). Higher scores reflect increased severity of disease.

    Measured: Change from Baseline to Week 12

  8. LS Mean of Change From Baseline in NMSS From a Mixed Model for Repeated Measures

    Non-Motor Symptom Score (NMSS) is a 30 question assessment completed by the clinician designed to evaluate the non-motor symptoms of Parkinson's disease. Scores range from 0 to 360 with higher scores reflect increasing severity of disease

    Measured: Change from Baseline to Week 12

  9. LS Mean of Change From Baseline in CSBM Score From a Mixed Model for Repeated Measures

    The Complete Spontaneous Bowel Movement (CSBM) Diary is a participant-completed paper diary used to record bowel movement activity over a 7-day period. Each entry captures the date and time of the bowel movement, stool consistency (Bristol Stool Form Scale), and whether the bowel movement was spontaneous (no laxative or rescue medication within the previous 24 hours) and complete (a sensation of full evacuation).

    The weekly CSBM score is calculated as the total number of complete and spontaneous bowel movements recorded during the 7-day period. Rome IV criteria defines constipation as having less than 3 CSBMs per 7 day period. A decrease in CSBM score represents a decrease in bowel function.

    Measured: Change from Baseline to Week 12

  10. LS Mean of Change From Baseline in ESS From a Mixed Model for Repeated Measures

    The Epworth Sleepiness Scale is a self-administered questionnaire that measures a participant's general level of daytime sleepiness. Participants rate their likelihood of dozing off or falling asleep in eight common situations using a 4-point scale from 0 = would never doze to 3 = high chance of dozing. The total ESS score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.

    Measured: Change from Baseline to Week 12

  11. LS Mean of Change From Baseline in SE-ADL From a Mixed Model for Repeated Measures

    Schwab and England Activies of Daily Living (SE-ADL) is a clinician administered assessment whereby participants assess their ability to complete routine daily activities on a scale from 0 to 100. The score is reported in increments of 10 with 100 representing normal ability to complete daily activities.

    Measured: Change from Baseline to Week 12

  12. LS Mean of Change From Baseline in PAGI-SYM From a Mixed Model for Repeated Measures

    The Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) is a participant-reported questionnaire designed to assess the severity of upper gastrointestinal symptoms over the previous two weeks. The instrument includes 20 items. Each item is rated on a 6-point Likert scale from 0 = none to 5 = very severe, with higher scores indicating greater symptom severity. A total score is calculated as the mean of non-missing item responses.

    Measured: Change from Baseline to Week 12

  13. LS Mean of Change From Baseline in PAC-QoL From a Mixed Model for Repeated Measures

    The Patient Assessment of Constipation Quality of Life (PAC-QOL) is a participant-reported questionnaire that evaluates the impact of constipation and its treatment on quality of life over the previous two weeks. It consists of 28 items. Each item is rated on a 5-point Likert scale from 0 = not at all / very satisfied to 4 = extremely / very dissatisfied, depending on item phrasing. Scores are calculated as the mean of all non-missing items, with higher scores indicating greater negative impact on quality of life.

    Measured: Change from Baseline to Week 12

  14. LS Mean of Change From Baseline in PAGI-QoL From a Mixed Model for Repeated Measures

    The Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QOL) is a validated, participant-reported questionnaire that assesses the impact of upper gastrointestinal symptoms on quality of life over the previous two weeks. The instrument includes 30 items. Each item is rated on a 6-point Likert scale from 0 = none of the time to 5 = all of the time. Scores are calculated as the mean of all non-missing items, with lower scores represent a greater negative impact on a participant's quality of life.

    Measured: Change from Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start15 May 2023
  3. Primary completion25 Oct 2024
  4. Study completion13 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05424276
Sponsor's protocol ID
IkT-148009-201
Status last verified
Oct 2025
First submitted
10 Jun 2022
Last updated
19 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Werner MH, McGarry A, Meyer C, Mancino E, Klint C, Pellecchia J, Kieburtz K, Levine T, Bellaire B, Gibbons C, Freeman R, Ellenbogen A, Klos K, Ospina M, Hauser RA, Shannon K, Asaad H, Park A, McAllister P, Isaacson SH, LeDoux MS, Dhall R, Shpiner D, Charles P, Agarwal P, Peckham E, Mazzeo P, Davis M, Pahwa R, Brodsky M, Lew M, Purino L, Mantri S, Parashos S, Justiz W, Chachar M, Robottom B, Budman E, Blindauer K, Bellows S, Goudreau J, Steen S, Olanow CW. The 201 Trial: a placebo-controlled randomized phase 2 study of safety and tolerance of the c-Abl kinase inhibitor risvodetinib in untreated Parkinson's disease. Nat Aging. 2026 Mar;6(3):626-635. doi: 10.1038/s43587-026-01084-4. Epub 2026 Feb 20.

    PubMed 41721133

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IkT-148009 (risvodetinib) in people with Parkinson Disease, run by ABLi Therapeutics, Inc. at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05424276, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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