A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
NCT ID: NCT07191483
Last Updated: 2025-09-25
Study Results
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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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-08-27
2026-12-31
Brief Summary
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Participants will be randomized to one of 4 treatment groups: placebo, KYN-5356 low dose, KYN-5356 medium dose, KYN-5356 high dose.
Participants will be admitted to the clinic on Day -3 and will remain in residence at the clinic for 32 days, from baseline through the treatment period.
Participants will be administered investigational medicinal product on Days 1 through 28. Efficacy, safety, PK and exploratory PD assessments will be performed throughout the dosing period. Participants will be discharged on Day 29 after safety assessments are completed and return for a follow-up visit on Day 42.
A subset of participants from selected sites will undergo electrophysiological assessments to evaluate the effect of KYN-5356 on neurophysiological measures of brain function.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KYN-5356 low dose
KYN-5356 low dose, oral tablet for 28 days
KYN-5356 low dose
oral tablet
KYN-5356 medium dose
KYN-5356 medium dose, oral tablet for 28 days
KYN-5356 Medium Dose
oral tablet
KYN-5356 high dose
KYN-5356 high dose, oral tablet for 28 days
KYN-5356 High Dose
oral tablet
Placebo
Placebo, oral tablet for 28 days
Placebo
Oral tablet
Interventions
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KYN-5356 low dose
oral tablet
Placebo
Oral tablet
KYN-5356 Medium Dose
oral tablet
KYN-5356 High Dose
oral tablet
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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Kynexis B.V.
INDUSTRY
Responsible Party
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Locations
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Woodland International Research Group
Little Rock, Arkansas, United States
Synergy Research Center
Lemon Grove, California, United States
Cenexel CNS
Los Alamitos, California, United States
Cenexel RCA
Hollywood, Florida, United States
Segal Trials
Miami Lakes, Florida, United States
Cenexel ACMR
Atlanta, Georgia, United States
Cenexel iResearch Atlanta
Decatur, Georgia, United States
Uptown Research Institute
Chicago, Illinois, United States
Cenexel CBH
Gaithersburg, Maryland, United States
Arch Clinical Trials
St Louis, Missouri, United States
Cenexel HRI
Marlton, New Jersey, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States
Community Clinical Research
Austin, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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KYN5356-CL-002
Identifier Type: -
Identifier Source: org_study_id
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