Cognitive Impairment Associated With Schizophrenia (CIAS)Phase 2NCT07191483
A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
A Phase 2 study testing KYN-5356 low dose, KYN-5356 Medium Dose and KYN-5356 High Dose in people with Cognitive Impairment Associated With Schizophrenia (CIAS), run by Kynexis B.V. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cognitive Impairment Associated With Schizophrenia (CIAS)
- What is being tested?
- KYN-5356 low dose, KYN-5356 Medium Dose and KYN-5356 High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 15 sitesUnited States
- Study dates
- 27 Aug 2025to 16 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Cenexel ACMR
Atlanta, Georgia, 30331
Community Clinical Research
Austin, Texas, 78754
NeuroBehavioral Hospitals of the Palm Beaches - South
Boynton Beach, Florida, 33426
Synapse Clinical Trials
Cerritos, California, 80703
Uptown Research Institute
Chicago, Illinois, 60640
Cenexel iResearch Atlanta
Decatur, Georgia, 30030
Cenexel CBH
Gaithersburg, Maryland, 20877
Cenexel RCA
Hollywood, Florida, 33024
Synergy Research Center
Lemon Grove, California, 92064
Woodland International Research Group
Little Rock, Arkansas, 72211
Cenexel CNS
Los Alamitos, California, 90720
Cenexel HRI
Marlton, New Jersey, 08053
Segal Trials
Miami Lakes, Florida, 33016
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720
Arch Clinical Trials
St Louis, Missouri, 63125
About this study
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
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.
Read more
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.
- Being tested
- KYN-5356 low dose, Placebo, KYN-5356 Medium Dose, KYN-5356 High Dose
- Keywords
- Schizophrenia, Cognitive Dysfunction
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KYN-5356 low doseDrug
oral tablet
PlaceboOther
Oral tablet
KYN-5356 Medium DoseDrug
oral tablet
KYN-5356 High DoseDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| KYN-5356 low dose | Experimental | KYN-5356 low dose, oral tablet for 28 days Receives: Drug: KYN-5356 low dose |
| KYN-5356 medium dose | Experimental | KYN-5356 medium dose, oral tablet for 28 days Receives: Drug: KYN-5356 Medium Dose |
| KYN-5356 high dose | Experimental | KYN-5356 high dose, oral tablet for 28 days Receives: Drug: KYN-5356 High Dose |
| Placebo | Placebo comparator | Placebo, oral tablet for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (5)
Cmax
Maximum concentration (Cmax) of KYN-5356 and relevant KYN-5356 metabolites on Day 1 and Day 28
Measured: 28 days
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
Measured: 28 Days
Tmax
Time to Cmax (Tmax) of KYN-5356 and relevant KYN-5356 metabolites on Day1 and Day 28
Measured: 28 Days
Ctrough
Trough concentration (Ctrough) of KYN-5356 and relevant KYN-5356 metabolites on Days 1, 7, 14, 21, and 28
Measured: 28 Days
Terminal half-life (t1/2)
Terminal half-life (t1/2) after the last dose on Day 28 for KYN-5356 and relevant KYN-5356 metabolites
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start27 Aug 2025
- Primary completion9 Sep 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment Associated With Schizophrenia (CIAS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kynexis B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191483
- Sponsor's protocol ID
- KYN5356-CL-002
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07191483
- Acronym / sponsor ID
- KYN5356-CL-002
- Keywords
- Schizophrenia, Cognitive Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Kynexis B.V.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KYN-5356 low dose | Experimental | Drug: KYN-5356 low doseKYN-5356 low dose, oral tablet for 28 days |
| KYN-5356 medium dose | Experimental | Drug: KYN-5356 Medium DoseKYN-5356 medium dose, oral tablet for 28 days |
| KYN-5356 high dose | Experimental | Drug: KYN-5356 High DoseKYN-5356 high dose, oral tablet for 28 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, oral tablet for 28 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KYN-5356 low doseoral tablet | Drug | KYN-5356 low dose |
| PlaceboOral tablet | Other | Placebo |
| KYN-5356 Medium Doseoral tablet | Drug | KYN-5356 medium dose |
| KYN-5356 High Doseoral tablet | Drug | KYN-5356 high dose |
Primary outcome
To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)
Time frame: 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
5 secondary outcomes
Cmax
Time frame: 28 days
AUCtau
Time frame: 28 Days
Tmax
Time frame: 28 Days
Ctrough
Time frame: 28 Days
Terminal half-life (t1/2)
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KYN-5356 low dose, KYN-5356 Medium Dose and KYN-5356 High Dose in people with Cognitive Impairment Associated With Schizophrenia (CIAS), run by Kynexis B.V. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.