NCT07191483

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

StatusCompleted

PhasePhase 2

SponsorKynexis B.V.

Primary completionSep 9, 2026

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

Minor Oct 21, 2026 Trial completed Show 6 more changesShow less
- Study completion date changed from estimate of Dec 2026 to Sep 16, 2026
- Enrollment target: estimated 150 to confirmed 149
- Primary completion date changed from estimate of Oct 2026 to Sep 9, 2026
- Eligibility criteria expanded, about 12 words
- Secondary endpoints: details revised at 1 of 5 entries
- Site details revised at 15 of 15 sites
Notable Jun 22, 2026 Primary completion date: Oct 2025 to Oct 2026
- Study sites: 13 to 15
v3
Minor Sep 24, 2025 Site contacts updated at 1 of 13 sitesv2
Sep 22, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)

Timeframe: 28 days

Secondary (5)

Cmax

AUCtau

Tmax

Ctrough

Terminal half-life (t1/2)

Arms and interventions

KYN-5356 low doseExperimental

KYN-5356 low dose, oral tablet for 28 days

KYN-5356 medium doseExperimental

KYN-5356 medium dose, oral tablet for 28 days

KYN-5356 high doseExperimental

KYN-5356 high dose, oral tablet for 28 days

PlaceboPlacebo comparator

Placebo, oral tablet for 28 days

Drugs: KYN-5356 low dose, KYN-5356 Medium Dose, KYN-5356 High Dose

Other: Placebo

Sites

15 sites in 1 country

About this trial

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 details

Enrollment: 149 participants (actual)
Started: Aug 27, 2025
Study completion: Sep 16, 2026
Eligibility: 18 to 55, all sexes, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee, FDA-regulated drug
Conditions: Cognitive Dysfunction, Schizophrenia, Cognitive Impairment Associated With Schizophrenia (CIAS)
Official title: 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
First posted: Sep 24, 2025
Registry updated: Oct 23, 2026
Last verified: Oct 2026

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