Dysautonomia International

Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia

Participant is aged 18 to 65 years, inclusive, at screening 2. Participant is capable of providing informed consent 3. 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) 4. 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 5. Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening 1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms 2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening 6. 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: i. Item 1 (P1; delusions) ii. Item 2 (P2; conceptual disorganization) iii. Item 3 (P3; hallucinatory behavior) iv. Item 6 (P6; suspiciousness/persecution)

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) 2. History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia 3. Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded 4. Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline Other protocol-defined inclusion/exclusion criteria may apply

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm	Description	Assigned Intervention
Experimental GXV813	GXV813 administered orally.	Drug: GXV813 GXV813 administered orally.
Placebo Comparator Placebo	Placebo administered orally.	Drug: Placebo Placebo administered orally.

Uptown Research Institute LLC
Chicago, Illinois 60640

Arch Clinical Trials LLC
St Louis, Missouri 63141

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com