Status:
RECRUITING
A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
Lead Sponsor:
Kynexis B.V.
Conditions:
Cognitive Impairment Associated With Schizophrenia (CIAS)
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of 3 different dose regiments of KYN-5356 ...
Eligibility Criteria
Inclusion
- Has an established primary psychiatric diagnosis of schizophrenia
- Clinically stable and in the residual (nonacute) phase of their illness for at least 8 weeks before screening in the judgement of the investigator
- Diagnosis of schizophrenia for at least 1 year before screening
- Must be in ongoing maintenance antipsychotic monotherapy on a stable medication treatment regimen for ≥ 2 months before screening, including concomitant psychotropic medications.
- Male or female, aged ≥18 and ≤55 years
- Has a body mass index (BMI) between 18 and 40 kg/m2 Inclusive
- Must exhibit capability to comply with all protocol procedures in the judgement of the investigator
- Signed and dated written informed consent before screening in accordance with Good Clinical Practice.
Exclusion
- Currently being treated with more than 1 antipsychotic at the time of screening,
- A score of 2 or higher on any of the individual items of the Modified Simpson-Angus Scale (mSAS) at screening
- Moderate to severe substance use disorder (other than nicotine or caffeine, but including alcohol)
- Evidence of unstable medical condition
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07191483
Start Date
August 27 2025
End Date
December 1 2026
Last Update
September 25 2025
Active Locations (13)
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1
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
2
Synergy Research Center
Lemon Grove, California, United States, 92064
3
Cenexel CNS
Los Alamitos, California, United States, 90720
4
Cenexel RCA
Hollywood, Florida, United States, 33024