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

ConditionCognitive Impairment Associated With Schizophrenia (CIAS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorKynexis B.V.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • KYN-5356 low dose

    Drug

    oral tablet

  • Placebo

    Other intervention

    Oral tablet

  • KYN-5356 Medium Dose

    Drug

    oral tablet

  • KYN-5356 High Dose

    Drug

    oral tablet

Treatment groups

150 Participants
are divided into 4 treatment groups
Group A: KYN-5356 low doseExperimental treatment 1 intervention
Group B: KYN-5356 medium doseExperimental treatment 1 intervention
Group C: KYN-5356 high doseExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
28 days

Secondary outcomes

1

Cmax

Maximum concentration (Cmax) of KYN-5356 and relevant KYN-5356 metabolites on Day 1 and Day 28

Time frame
28 days
2

AUCtau

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

Time frame
28 Days
3

Tmax

Time to Cmax (Tmax) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28

Time frame
28 Days
4

Ctrough

Trough concentration (Ctrough) of KYN-5356 and relevant KYN-5356 metabolites on Days 1, 7, 14, 21, and 28

Time frame
28 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kynexis B.V.

Lead sponsor

Source ClinicalTrials.gov
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