Clinical Trials / Browse by Phase / Phase 2 / Phase 3
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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
119
Recruiting Now
119
Top Conditions in Phase 2 / Phase 3
Acute Ischemic Stroke (3) Ketosis (2) Prostate Cancer (2) Delirium (2) Stereotactic Body Radiation Therapy (SBRT) (2) Dose Escalation: Solid Tumors (2) Generalized Myasthenia Gravis (2) Sanfilippo Syndrome (2) Mucopolysaccharidosis III (2) Diffuse Large B-Cell Lymphoma (DLBCL) (2)

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

NCT06568484 Phase 2, Phase 3
Recruiting
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent ...
Condition
Tuberculosis, Latent
Enrollment
2,530 pts
Location
Mongolia, Peru, Tanzania
Sponsor
Johns Hopkins University
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NCT05786768 Phase 2, Phase 3
Recruiting
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Depend...
Condition
Steroid-Dependent Nephrotic Syndrome
Enrollment
88 pts
Location
France
Sponsor
Assistance Publique - Hôpitaux
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NCT03031210 Phase 2, Phase 3
Recruiting
Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumon...
Condition
Community-acquired Pneumonia
Enrollment
1,370 pts
Location
Canada
Sponsor
St. Justine's Hospital
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NCT04273607 Phase 2, Phase 3
Recruiting
Anticoagulation-free VV ECMO for Acute Respiratory Failure
Condition
Extracorporeal Membrane Oxygenation Complication
Enrollment
40 pts
Location
Canada
Sponsor
Damian Ratano
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NCT06872736 Phase 2, Phase 3
Recruiting
Wereables for Upper Limb Functionality in Hemiparesis
Condition
Unilateral Cerebral Palsy
Enrollment
40 pts
Location
Spain
Sponsor
Universidade da Coruña
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NCT06011889 Phase 2, Phase 3
Recruiting
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO ...
Condition
SAPHO Syndrome
Enrollment
60 pts
Location
Poland
Sponsor
National Institute of Geriatri
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NCT02265770 Phase 2, Phase 3
Recruiting
An International Clinical Program for the Diagnosis and Treatment of Children Wi...
Condition
Childhood Ependymoma
Enrollment
536 pts
Location
Austria, Belgium, Czechia
Sponsor
Centre Leon Berard
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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
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NCT06907602 Phase 2, Phase 3
Recruiting
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamo...
Condition
Locally Advanced Esophageal Squamous Cell Carcinoma
Enrollment
120 pts
Location
China
Sponsor
Peking Union Medical College H
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NCT07592273 Phase 2, Phase 3
Recruiting
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Particip...
Condition
Diabetic Retinopathy
Enrollment
576 pts
Location
United States, Puerto Rico
Sponsor
AbbVie
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NCT06815237 Phase 2, Phase 3
Recruiting
Effects of Ketone Supplement and Alcohol on Brain Metabolism
Condition
Ketosis
Enrollment
60 pts
Location
United States
Sponsor
University of Pennsylvania
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NCT07736495 Phase 2, Phase 3
Recruiting
Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis
Condition
Colorectal Cancer
Enrollment
50 pts
Location
Egypt
Sponsor
Ain Shams University
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NCT06947928 Phase 2, Phase 3
Recruiting
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint In...
Condition
Advanced Or Metastatic Merkel Cell Carcinoma
Enrollment
118 pts
Location
United States
Sponsor
TuHURA Biosciences, Inc.
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NCT05786599 Phase 2, Phase 3
Recruiting
Methadone to Treat Painful Chemotherapy Induced Peripheral Neuropathy
Condition
Chemotherapy-induced Peripheral Neuropathy
Enrollment
50 pts
Location
Canada
Sponsor
University of British Columbia
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NCT06607419 Phase 2, Phase 3
Recruiting
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnos...
Condition
B-Cell Lymphoblastic Leukemia
Enrollment
90 pts
Location
China
Sponsor
Shanghai Jiao Tong University
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NCT06672887 Phase 2, Phase 3
Recruiting
Enhancing Successful Return to Work of Employees With Cancer, by Supporting Empl...
Condition
Cancer
Enrollment
140 pts
Location
Netherlands
Sponsor
Academisch Medisch Centrum - U
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NCT03701581 Phase 2, Phase 3
Recruiting
4-aminopyridine Treatment for Nerve Injury
Condition
Nerve Injury
Enrollment
70 pts
Location
United States
Sponsor
John Elfar
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NCT07284472 Phase 2, Phase 3
Recruiting
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzh...
Condition
Agitation Associated With Alzheimer's Disease Dementia
Enrollment
300 pts
Location
United States, Canada, Czechia
Sponsor
Exciva GmbH
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NCT07709598 Phase 2, Phase 3
Recruiting
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia i...
Condition
Postoperative Pain
Enrollment
330 pts
Location
China
Sponsor
Shanghai Huilun Pharmaceutical
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NCT07114055 Phase 2, Phase 3
Recruiting
Effect of Ebastine in Patients With Diarrhea Predominant Irritable Bowel Syndrom...
Condition
Irritable Bowel Syndrome - Diarrhoea
Enrollment
60 pts
Location
Bangladesh
Sponsor
Md. Hazrat Ali
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NCT06478108 Phase 2, Phase 3
Recruiting
Interventional Software for Multi-immunotherapy of Solid Tumors
Condition
Lung Cancer
Enrollment
60 pts
Location
China
Sponsor
Second Affiliated Hospital of
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NCT06531642 Phase 2, Phase 3
Recruiting
Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute ...
Condition
Acute Kidney Injury
Enrollment
100 pts
Location
United States
Sponsor
The University of Texas Health
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NCT05431595 Phase 2, Phase 3
Recruiting
Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neurolepti...
Condition
Delirium
Enrollment
42 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT06129175 Phase 2, Phase 3
Recruiting
UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-E...
Condition
Acute Ischemic Stroke
Enrollment
80 pts
Location
Malaysia
Sponsor
Cytopeutics Sdn. Bhd.
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NCT07573956 Phase 2, Phase 3
Recruiting
Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated ...
Condition
Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
Enrollment
369 pts
Location
India
Sponsor
All India Institute of Medical
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