2025-524058-32-00RecruitingPhase 2
A Phase 2 Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with Schizophrenia (STAR-1)
A Phase 2a, Randomized, Participant- and Investigator blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with DSM-5 Schizophrenia (STAR-1)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- 22 Jun 2026
- Lead sponsor
- Novartis Pharma AG
- Diseases
- Schizophrenia
- EU CT number
- 2025-524058-32-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with schizophrenia who are having an acute flare-up and need to stay in hospital for the whole study.
- Age
- 18 to 65 years at screening (the record's age fields say 18 to 64 years).
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia diagnosed by DSM-5 criteria, in an acute worsening that began less than 2 months before screening. Needs hospital care; if already in hospital, for less than 2 weeks for this episode. PANSS total score between 80 and 120.
- Earlier treatment
- People with no response to two adequate courses of antipsychotic medicine, or earlier clozapine for treatment-resistant schizophrenia, cannot join. A long-acting injectable antipsychotic must not have been given for at least 12 weeks (24 weeks for INVEGA TRINZA®) before baseline.
Main reasons for not taking part
- Any main DSM-5 disorder other than schizophrenia in the 12 months before screening
- History of no response to two adequate antipsychotic courses, or earlier clozapine for treatment-resistant schizophrenia
- Needing drugs that are moderate or strong CYP3A4 inhibitors or inducers
- Long-acting injectable antipsychotic given too recently (less than 12 weeks, or 24 weeks for INVEGA TRINZA®, before baseline)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
- Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
- 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
Who the study is looking for
- Participant is aged 18 to 65 years, inclusive, at screening
- Participant is capable of providing informed consent
- 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)
- 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
- 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
- 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)
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center For Mental Health Prof. Dr. Ivan Temkov Burgas EOOD | Burgas | Bulgaria | Recruiting |
| Mental Health Center - Haskovo EOOD | Haskovo | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD | Kazanlik | Bulgaria | Recruiting |
| State Psychiatric Hospital - Lovech | Lovech | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD | Plovdiv | Bulgaria | Recruiting |
| MBAL Dr. Ivan Seliminski Sliven AD | Sliven | Bulgaria | Recruiting |
| Alexandrovska University Hospital | Sofia | Bulgaria | Recruiting |
| Center For Mental Health Prof. N. Shipkovenski EOOD | Sofia | Bulgaria | Recruiting |
| Center Za Psihichno Zdrave Veliko Tarnovo EOOD | Veliko Tirnovo | Bulgaria | Recruiting |
| Center For Mental Health Vratsa EOOD | Vratsa | Bulgaria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.