A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia

Not Applicable

Recruiting

• Conditions: Cognitive Impairment Associated With Schizophrenia (CIAS)
• Interventions: Drug: KYN-5356 low dose; Drug: KYN-5356 Medium Dose; Drug: KYN-5356 High Dose; Other: Placebo

• Registration Number: NCT07191483
• Lead Sponsor: Kynexis B.V.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-22
• Study First Posted: 2025-09-24
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-25
• Primary Completion: 2025-10
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KYN-5356 low dose	KYN-5356 low dose	KYN-5356 low dose, oral tablet for 28 days
KYN-5356 medium dose	KYN-5356 Medium Dose	KYN-5356 medium dose, oral tablet for 28 days
KYN-5356 high dose	KYN-5356 High Dose	KYN-5356 high dose, oral tablet for 28 days
Placebo	Placebo	Placebo, oral tablet for 28 days

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)	28 days	Change from Baseline at Day 28 in the digital version of the Brief Assessment of Cognition for Schizophrenia (BAC App) composite T-score

Secondary Outcome Measures

Name	Time	Method
Cmax	28 days	Maximum concentration (Cmax) of KYN-5356 and relevant KYN-5356 metabolites on Day 1 and Day 28
AUCtau	28 Days	Area under the concentration-time curve from time 0 to tau (end of dosing interval) (AUCtau) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28
Tmax	28 Days	Time to Cmax (Tmax) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28
Ctrough	28 Days	Trough concentration (Ctrough) of KYN-5356 and relevant KYN-5356 metabolites on Days 1, 7, 14, 21, and 28
Terminal half-life (t1/2)	28 Days	Terminal half-life (t1/2) after the last dose on Day 28 for KYN-5356 and relevant KYN-5356 metabolites

Trial Locations

Locations (13)

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

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