Phase 2
N=137
A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT05424276 ↗Enrolled (actual)
137
Serious AEs
2.2%
Results posted
Nov 2025
Primary outcome: Primary: Incidence of Treatment-emergent Adverse Events (TEAEs) — 19; 21; 21; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IkT-148009 (risvodetinib) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- ABLi Therapeutics, Inc.
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events (TEAEs) |
19; 21; 21; 21 | — |
| PRIMARY Proportion of Those Randomized in Each Dosing Cohort Who Discontinued the Assigned Regimen Due to an Adverse Event |
1; 0; 1; 1 | — |
| SECONDARY LS Mean of Change From Baseline in MDS-UPDRS Part II+III From a Mixed Model for Repeated Measures |
0.08; 1.82; 2.12; 0.85 | 0.686 |
| SECONDARY LS Mean of Change From Baseline in PDQ-39 From a Mixed Model for Repeated Measures |
-1.90; -0.99; -1.89; -2.35 | 0.683 |
| SECONDARY LS Mean of Change From Baseline in PGI-S From a Mixed Model for Repeated Measures |
0.04; 0.13; 0.03; -0.04 | 0.463 |
| SECONDARY LS Mean of Change From Baseline in CGI-S From a Mixed Model for Repeated Measures |
-0.08; 0.13; -0.02; 0.11 | 0.178 |
| SECONDARY LS Mean of Change From Baseline in MDS-UPDRS Part II From a Mixed Model for Repeated Measures |
0.11; -0.32; -0.08; 1.09 | 0.144 |
| SECONDARY LS Mean of Change From Baseline in MDS-UPDRS Part III From a Mixed Model for Repeated Measures |
-0.04; 2.14; 2.20; -0.21 | 0.916 |
| SECONDARY LS Mean of Change From Baseline in MDS-UPDRS Part I From a Mixed Model for Repeated Measures |
-0.93; -1.03; 0.22; -0.26 | 0.297 |
| SECONDARY LS Mean of Change From Baseline in NMSS From a Mixed Model for Repeated Measures |
0.14; 0.79; 0.88; -0.14 | 0.943 |
| SECONDARY LS Mean of Change From Baseline in CSBM Score From a Mixed Model for Repeated Measures |
-0.04; 0.30; -0.11; 0.85 | 0.173 |
| SECONDARY LS Mean of Change From Baseline in ESS From a Mixed Model for Repeated Measures |
-0.46; -0.30; -0.76; -0.68 | 0.704 |
| SECONDARY LS Mean of Change From Baseline in SE-ADL From a Mixed Model for Repeated Measures |
0.02; -0.00; -0.00; -0.02 | 0.004 sig |
| SECONDARY LS Mean of Change From Baseline in PAGI-SYM From a Mixed Model for Repeated Measures |
-0.04; -0.02; -0.09; 0.05 | 0.321 |
| SECONDARY LS Mean of Change From Baseline in PAC-QoL From a Mixed Model for Repeated Measures |
-0.03; -0.17; -0.13; -0.03 | 0.950 |
| SECONDARY LS Mean of Change From Baseline in PAGI-QoL From a Mixed Model for Repeated Measures |
0.07; 0.06; 0.06; 0.05 | 0.803 |
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
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT05424276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.