GXV813 for Schizophrenia

Inclusion criteria

• {"criterion_text":"- Participant is aged 18 to 65 years, inclusive, at screening"}
• {"criterion_text":"- Participant is capable of providing informed consent"}
• {"criterion_text":"- Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)"}
• {"criterion_text":"- Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements"}
• {"criterion_text":"- Participant is experiencing an acute exacerbation with onset less than 2 months before screening a. The participant requires hospitalization for this acute exacerbation or relapse of symptoms b. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening"}
• {"criterion_text":"- Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution)"}

Exclusion criteria

• {"criterion_text":"- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID- 5-CT) at screening)"}
• {"criterion_text":"- History of treatment resistance to antipsychotic medications defined as no response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia"}
• {"criterion_text":"- Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded"}
• {"criterion_text":"- Participants taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for INVEGA TRINZA®) before baseline"}
• {"criterion_text":"- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID- 5-CT) at screening)"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in PANSS (Positive and Negative Symptom Scale) total score at 6 weeks","definition_or_measurement_approach":"Change from baseline measured by PANSS total score at Week 6"}

Secondary endpoints

• {"endpoint_text":"- Occurrence and severity of AEs, clinical laboratory tests, vital signs, ECG findings, physical examination, Modified Simpson-Angus Scale (mSAS), Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS) and suicidality assessment (Columbia Suicide Severity Rating Scale C-SSRS)","definition_or_measurement_approach":"Safety and tolerability assessed by recording occurrence and severity of AEs and results of clinical labs, vital signs, ECG, physical exams and specified rating scales (mSAS, BARS, AIMS, C-SSRS)"}
• {"endpoint_text":"- Participant response; response is defined as clinically significant reduction in total PANSS (≥30% improvement in PANSS total score),OR a 1-point difference CGI-S-score at week 6.","definition_or_measurement_approach":"Responder defined as ≥30% improvement in PANSS total score OR a 1-point difference in CGI-S at Week 6"}
• {"endpoint_text":"- Change from baseline in PANSS positive subscore at week 6","definition_or_measurement_approach":"Change from baseline measured by PANSS positive subscore at Week 6"}
• {"endpoint_text":"- Change from baseline in PANSS negative subscore and Marder negative factor score at week 6","definition_or_measurement_approach":"Change from baseline measured by PANSS negative subscore and Marder negative factor score at Week 6"}
• {"endpoint_text":"- Change from baseline in Clinical Global Impression‒Severity (CGI-S) scale at week 6","definition_or_measurement_approach":"Change from baseline measured by CGI-S at Week 6"}
• {"endpoint_text":"- PK parameters such as but not limited to area under the plasma concentration-time curve (AUC), maximum observed plasma concentration (Cmax)","definition_or_measurement_approach":"Pharmacokinetic parameters measured from plasma concentrations including AUC and Cmax"}

Methods

• Physician Referral Letter (materials present: Physician Referral Letter, Bulgarian and Global versions) targeted to healthcare professionals
• Site Posters (Site Poster and Bulgarian site poster) to be displayed at study sites
• Patient-facing brochures and Pre-enrolment Information Card (Patient Brochure, Pre-enrolment Information Card) for potential participants
• Doctor-to-Patient Letter (K2_1) for direct communication from clinicians to patients
• Family/Informant brochures (Family-Informant Brochure) to inform relatives/informants
• HCP Fact Sheet (HCP Fact Sheet and Bulgarian version) for healthcare professionals
• Study Information Slides and Talking Points Guide for site staff and outreach

Bulgaria

Earliest CTIS Part Ii Submission Date

22-04-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

7

Number Of Sites

10

Number Of Participants

42

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

code: 1

Name

Parexel International (IRL) Limited

Responsibilities

code: 12

Name

Syneos Health Inc.

Responsibilities

code: 1

Name

IQVIA Limited

Responsibilities

DNA extraction, eCOA, ECG; codes: 1,10,12,15,3,4,5,6

Third parties

• {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"WebPatient Secure Platform","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"Site Cloud","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Long-term sample storage","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Denmark","full_name":"Eurofins Genomics Europe AgriGenomics Products & Services A/S","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code: 12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"DNA extraction, eCOA, ECG; codes: 1,10,12,15,3,4,5,6","organisation_type":"Pharmaceutical company"}