A Phase 2 Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with Schizophrenia (STAR-1)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2026-04-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety

To assess the efficacy of GXV813 compared to placebo on positive and negative symptoms in
adult inpatients with schizophrenia diagnosed according to DSM-5 criteria experiencing an
acute episode

Secondary objectives 6

1. To assess overall safety and tolerability of GXV813 versus placebo in adult inpatients with schizophrenia
2. To assess responder rate difference between GXV813 and placebo arms
3. To assess the effect of GXV813 versus placebo on positive symptoms of schizophrenia
4. To assess the effect of GXV813 versus placebo on negative symptoms of schizophrenia
5. To assess the effect of GXV813 versus placebo on illness severity
6. To assess the pharmacokinetics (PK) of GXV813 and its XXX

Conditions and MedDRA coding

Schizophrenia

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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 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
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: 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 4

1. 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 no 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 for at least 12 weeks (24 weeks for INVEGA TRINZA®) before baseline

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in PANSS (Positive and Negative Symptom Scale) total score at 6 weeks

Secondary endpoints 6

1. 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)
2. 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.
3. Change from baseline in PANSS positive subscore at week 6
4. Change from baseline in PANSS negative subscore and Marder negative factor score at week 6
5. Change from baseline in Clinical Global Impression‒Severity (CGI-S) scale at week 6
6. PK parameters such as but not limited to area under the plasma concentration-time curve (AUC), maximum observed plasma concentration (Cmax)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 9

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 40 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications