[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07680946":3,"trial-entities:NCT07680946":88,"trial-summary:NCT07680946":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":41,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":60,"locations":62,"central_contacts":79,"overall_officials":85,"references":86,"see_also_links":87},"NCT07680946","TG1101-SSD-201","Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia","Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia","RECRUITING","2029-03-01","2026-07","2026-07-21","2026-07-03","TG Therapeutics, Inc.","INDUSTRY",false,"The main objective of this Phase 2 study is to assess the efficacy of ublituximab as measured by positive and negative syndrome scale (PANSS) total score in participants with schizophrenia.",null,[19],"Schizophrenia",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},60,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Ublituximab","Administered as an IV infusion.",[31],[35,36],"BRIUMVI","TG-1101",[38],{"measure":39,"timeFrame":40},"Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score","At Week 12",[42,45,48,50],{"measure":43,"timeFrame":44},"Change From Baseline in PANSS Total Score","Baseline, Week 12, 24, and 48",{"measure":46,"timeFrame":47},"Change From Baseline in Clinical Global Impressions - Improvement (CGI-I)","Baseline, Week 12, 24, 48",{"measure":49,"timeFrame":44},"Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4)",{"measure":51,"timeFrame":52},"Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)","Up to Week 48","ALL","18 Years","60 Years",{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. Primary diagnosis of schizophrenia.\n2. Treatment-resistant.\n3. Requires antipsychotic treatment and is currently receiving \"standard of care\".\n4. PANSS total score between 80 and 120, inclusive at screening and baseline.\n\nExclusion Criteria\n\n1. Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia.\n2. Ongoing clozapine treatment.\n3. Risk for suicidal behavior.\n4. Any severe or uncontrolled medical condition that could affect the participant's ability to participate.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply",[61],"ADULT",[63,72],{"facility":64,"status":8,"city":65,"state":66,"zip":67,"country":68,"geoPoint":69},"TG Therapeutics Investigational Trial Site","Little Rock","Arkansas","72204","United States",{"lat":70,"lon":71},34.74648,-92.28959,{"facility":64,"status":8,"city":73,"state":74,"zip":75,"country":68,"geoPoint":76},"Richardson","Texas","75080",{"lat":77,"lon":78},32.94818,-96.72972,[80],{"name":81,"role":82,"phone":83,"email":84},"TG Therapeutics Clinical Support Team","CONTACT","1-877-575-8489","clinicalsupport@tgtxinc.com",[],[],[],{"nct_id":4,"conditions":89,"biomarkers":90},[19],[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is a Phase 2 interventional study, meaning it's testing a specific treatment. It plans to enroll 60 participants.","completed","Ublituximab for Schizophrenia","This study is testing a drug called ublituximab to see if it can help people with schizophrenia. You might be able to join if you are between 18 and 60 years old, have a primary diagnosis of schizophrenia, and your current treatment isn't fully working. Researchers will measure how much your symptoms improve using a scale called PANSS (Positive and Negative Syndrome Scale) after 12 weeks. The study is currently unclear about its recruitment status and plans to enroll about 60 participants.","The primary endpoint is measured at Week 12, suggesting follow-up for at least that long.",82,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]