Browse by Phase
Phase 2 / Phase 3 Clinical Trials
Phase 2/3 combined trials bridge efficacy assessment and large-scale comparison, enrolling larger cohorts while still gathering dose-response data.
Total Trials
118
Recruiting Now
118
Top Conditions in Phase 2 / Phase 3
Frequently Asked Questions — Phase 2 / Phase 3 Trials
What distinguishes a Phase 2/3 combined trial?
Phase 2/3 combined trials bridge efficacy assessment and large-scale comparative confirmation in a single expanding protocol. The Phase 2 portion identifies optimal dosing and collects early efficacy signals, while the Phase 3 portion expands enrollment and applies the primary statistical analysis to a larger population. This design reduces time from dose selection to pivotal evidence.
How large are Phase 2/3 combined trials?
Phase 2/3 trials are larger than standalone Phase 2 studies but may be smaller than fully powered Phase 3 trials. Enrollment typically ranges from 200 to 1,000 participants, depending on the condition, endpoint, and statistical requirements. Interim analyses allow sample size adjustment if early results indicate more statistical power is needed.
Who benefits most from Phase 2/3 trial designs?
Phase 2/3 designs particularly benefit patients with serious or rare conditions where standard treatments are inadequate. Because the Phase 2 and Phase 3 portions run as one continuous protocol, patients who enroll in Phase 2 may transition into the Phase 3 portion without interruption—a continuity of care advantage compared to sequential separate studies.
Active Phase 2 / Phase 3 Studies
NCT07656909 Phase 2, Phase 3
Recruiting
Low- vs High-Dose Sirolimus With Prednisolone for KHE and KMP
Condition
Kaposiform Hemangioendothelioma (KHE)
Enrollment
76 pts
Location
China
Sponsor
Yi Ji
NCT07459751 Phase 2, Phase 3
Recruiting
A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX4...
Condition
Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Enrollment
706 pts
Location
China
Sponsor
Shanghai Henlius Biotech
NCT06758830 Phase 2, Phase 3
Recruiting
Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cance...
Condition
Rectal Cancer
Enrollment
400 pts
Location
Lithuania
Sponsor
National Cancer Center Affilia
NCT04695600 Phase 2, Phase 3
Recruiting
Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia
Condition
Transfer Dysphagia
Enrollment
100 pts
Location
India
Sponsor
All India Institute of Medical
NCT04018729 Phase 2, Phase 3
Recruiting
Cell Therapy Associated With Endobronchial Valve
Condition
Chronic Obstructive Pulmonary Disease Severe
Enrollment
34 pts
Location
Brazil
Sponsor
Hospital de Clinicas de Porto
NCT07675980 Phase 2, Phase 3
Recruiting
Thymosin-α1 for Recurrent Implantation Failure
Condition
Recurrent Implantation Faliure
Enrollment
136 pts
Location
United Arab Emirates
Sponsor
Fakih IVF Fertility Center
NCT07388680 Phase 2, Phase 3
Recruiting
Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or W...
Condition
Radiation-induced Lung Injury
Enrollment
298 pts
Location
China
Sponsor
Beijing Continent Pharmaceutic
NCT07221370 Phase 2, Phase 3
Recruiting
Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infec...
Condition
Clostridium Difficile Infection
Enrollment
176 pts
Location
United States
Sponsor
Riverside University Health Sy
NCT07756723 Phase 2, Phase 3
Recruiting
The Many Roads to Trauma Recovery: A Clinical Trial Comparing Empirically Suppor...
Condition
Posttraumatic Stress Disorder (PTSD)
Enrollment
50 pts
Location
United States
Sponsor
Coatesville VA Medical Center
NCT06413368 Phase 2, Phase 3
Recruiting
Maralixibat in Patients With Cystic Fibrosis and Constipation
Condition
Constipation Chronic Idiopathic
Enrollment
20 pts
Location
United States
Sponsor
Children's Hospital Los Angele
NCT02657785 Phase 2, Phase 3
Recruiting
Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
Condition
Primary Central Nervous System Lymphoma
Enrollment
100 pts
Location
China
Sponsor
Navy General Hospital, Beijing
NCT05427084 Phase 2, Phase 3
Recruiting
Canagliflozin Targeting Vascular Inflammation
Condition
Diabetes Type 2
Enrollment
24 pts
Location
Canada
Sponsor
Ottawa Heart Institute Researc
NCT07675499 Phase 2, Phase 3
Recruiting
Exercise and Intranasal Insulin in Type 2 Diabetes
Condition
Type 2 Diabetes
Enrollment
60 pts
Location
United States
Sponsor
Rutgers, The State University
NCT07440225 Phase 2, Phase 3
Recruiting
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-...
Condition
Macular Degeneration
Enrollment
960 pts
Location
United States, Argentina, Australia
Sponsor
EyeBiotech Ltd.
NCT05665140 Phase 2, Phase 3
Recruiting
Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Mul...
Condition
Newly Diagnosed Multiple Myeloma
Enrollment
100 pts
Location
Germany
Sponsor
University Hopsital Schleswig
NCT06791460 Phase 2, Phase 3
Recruiting
Pegylated Liposomal Doxorubicin Plus Adebrelimab With or Without Mirabegron in R...
Condition
Ovarian Cancer Recurrent
Enrollment
296 pts
Location
China
Sponsor
Obstetrics & Gynecology Hospit
NCT07454720 Phase 2, Phase 3
Recruiting
A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiothera...
Condition
Locally Advanced Resectable Rectal Cancer
Enrollment
165 pts
Location
China
Sponsor
Suzhou Suncadia Biopharmaceuti
NCT06780670 Phase 2, Phase 3
Recruiting
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Pr...
Condition
Prostate Cancer
Enrollment
443 pts
Location
United States, Australia, Brazil
Sponsor
Novartis Pharmaceuticals
NCT05678621 Phase 2, Phase 3
Recruiting
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immun...
Condition
Haematological Malignancy
Enrollment
300 pts
Location
Australia
Sponsor
Monash University
NCT05926505 Phase 2, Phase 3
Recruiting
Safety and Efficacy of Anakinra Treatment for Patients With Post Acute Covid Syn...
Condition
Post-Acute COVID-19 Syndrome
Enrollment
182 pts
Location
Germany, Greece, Italy
Sponsor
Hellenic Institute for the Stu
NCT07165886 Phase 2, Phase 3
Recruiting
Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Inj...
Condition
Gastroenteropancreatic Neuroendocrine Tumors
Enrollment
298 pts
Location
China
Sponsor
CSPC ZhongQi Pharmaceutical Te
NCT06568770 Phase 2, Phase 3
Recruiting
Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Und...
Condition
Post Operative Pain
Enrollment
70 pts
Location
Pakistan
Sponsor
Sahiwal medical college sahiwa
NCT07095842 Phase 2, Phase 3
Recruiting
Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic...
Condition
Convulsive Status EPILEPTICUS
Enrollment
668 pts
Location
Egypt
Sponsor
Sohag University
NCT05991388 Phase 2, Phase 3
Recruiting
A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refract...
Condition
B-cell Non Hodgkin Lymphoma
Enrollment
210 pts
Location
Australia, Austria, Belgium
Sponsor
University of Birmingham
NCT05213169 Phase 2, Phase 3
Recruiting
Apomorphine in Severe Brain-injured Patients
Condition
Disorder of Consciousness
Enrollment
48 pts
Location
Belgium, Spain
Sponsor
University of Liege
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