A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of KYN-5356 as Adjunctive Treatment in Adults With Cognitive Impairment Associated With Schizophrenia
1 other identifier
interventional
150
1 country
13
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 and placebo for 28 days. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2025
CompletedFirst Submitted
Initial submission to the registry
September 10, 2025
CompletedFirst Posted
Study publicly available on registry
September 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedSeptember 25, 2025
September 1, 2025
1 month
September 10, 2025
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)
Change from Baseline at Day 28 in the digital version of the Brief Assessment of Cognition for Schizophrenia (BAC App) composite T-score
28 days
Secondary Outcomes (5)
Cmax
28 days
AUCtau
28 Days
Tmax
28 Days
Ctrough
28 Days
Terminal half-life (t1/2)
28 Days
Study Arms (4)
KYN-5356 low dose
EXPERIMENTALKYN-5356 low dose, oral tablet for 28 days
KYN-5356 medium dose
EXPERIMENTALKYN-5356 medium dose, oral tablet for 28 days
KYN-5356 high dose
EXPERIMENTALKYN-5356 high dose, oral tablet for 28 days
Placebo
PLACEBO COMPARATORPlacebo, oral tablet for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kynexis B.V.lead
Study Sites (13)
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Synergy Research Center
Lemon Grove, California, 92064, United States
Cenexel CNS
Los Alamitos, California, 90720, United States
Cenexel RCA
Hollywood, Florida, 33024, United States
Segal Trials
Miami Lakes, Florida, 33016, United States
Cenexel ACMR
Atlanta, Georgia, 30331, United States
Cenexel iResearch Atlanta
Decatur, Georgia, 30030, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
Cenexel CBH
Gaithersburg, Maryland, 20877, United States
Arch Clinical Trials
St Louis, Missouri, 63125, United States
Cenexel HRI
Marlton, New Jersey, 08053, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720, United States
Community Clinical Research
Austin, Texas, 78754, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2025
First Posted
September 24, 2025
Study Start
August 27, 2025
Primary Completion
October 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
September 25, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share