NCT07191483CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 149 (actual)
- First submitted
- 10 Sept 2025
- Start date
- 27 Aug 2025
- Primary completion date
- 9 Sept 2026
- Lead sponsor
- Kynexis B.V.
- Diseases
- Schizophrenia
- NCT number
- NCT07191483
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 149
- From 27 Aug 2025 to the primary completion date, 9 Sept 2026
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently being treated with more than 1 antipsychotic at the time of screening,
Other illness
- Moderate to severe substance use disorder (other than nicotine or caffeine, but including alcohol)
- Evidence of unstable medical condition
Other
- A score of 2 or higher on any of the individual items of the Modified Simpson-Angus Scale (mSAS) at screening
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CenExel ACMR Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Community Clinical Research Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| NeuroBehavioral Hospitals of the Palm Beaches - South Coordinator of this site? Confirm its status | Boynton Beach | United States | Unknown status |
| Synapse Clinical Trials Coordinator of this site? Confirm its status | Cerritos | United States | Unknown status |
| Uptown Research Institute Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| CenExel - iResearch Atlanta Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| CenExel CBH Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| CenExel RCA Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Synergy Research Center Coordinator of this site? Confirm its status | Lemon Grove | United States | Unknown status |
| Woodland International Research Group Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| CenExel CNS Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| CenExel-HRI Coordinator of this site? Confirm its status | Marlton | United States | Unknown status |
| Segal Trials Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Neuro-Behavioral Clinical Research Coordinator of this site? Confirm its status | North Canton | United States | Unknown status |
| Arch Clinical Trials Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.