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
122
Recruiting Now
122
Top Conditions in Phase 2 / Phase 3
Gastric Cancer (2) Pancreatic Ductal Adenocarcinoma (2) Breast Cancer (2) Non-Squamous Non-Small Cell Lung Cancer (2) Primary Central Nervous System Lymphoma (2) Multiple Myeloma (2) HCC (2) Heart Failure (2) Acute Myeloid Leukemia (2) Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) (1)

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

NCT07342205 Phase 2, Phase 3
Recruiting
A Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Thr...
Condition
Acute Respiratory Distress Syndrome (ARDS)
Enrollment
60 pts
Location
China
Sponsor
Shanghai University of Traditi
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NCT06414005 Phase 2, Phase 3
Recruiting
A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear
Condition
Partial Thickness Rotator Cuff Tear
Enrollment
166 pts
Location
South Korea
Sponsor
Tego Science, Inc.
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NCT06783166 Phase 2, Phase 3
Recruiting
Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patient...
Condition
Acute Heart Failure
Enrollment
100 pts
Location
Egypt
Sponsor
Mansoura University
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NCT06999902 Phase 2, Phase 3
Recruiting
Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Eval...
Condition
Focal Seizure
Enrollment
230 pts
Location
United States, Spain
Sponsor
Praxis Precision Medicines
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NCT07366801 Phase 2, Phase 3
Recruiting
Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic S...
Condition
Acute Myeloid Leukemia, Relapsed
Enrollment
64 pts
Location
Russia
Sponsor
Federal Research Institute of
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NCT06132893 Phase 2, Phase 3
Recruiting
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory...
Condition
Focal Epilepsy
Enrollment
390 pts
Location
United States, Argentina, Austria
Sponsor
Biohaven Therapeutics Ltd.
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NCT06185816 Phase 2, Phase 3
Recruiting
Non-Invasive Pulsed Radiofrequency for the Treatment of Neuropathic Pain
Condition
Pain, Nerve
Enrollment
95 pts
Location
United States
Sponsor
Stanford University
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NCT07594314 Phase 2, Phase 3
Recruiting
Minocycline After Successful Endovascular Thrombectomy Recanalization in Acute A...
Condition
Acute Ischemic Stroke
Enrollment
860 pts
Location
China
Sponsor
Xiang Luo
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NCT06424834 Phase 2, Phase 3
Recruiting
Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arter...
Condition
Angina Pectoris
Enrollment
150 pts
Location
United States
Sponsor
Stanford University
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NCT05693142 Phase 2, Phase 3
Recruiting
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular D...
Condition
Duchenne Muscular Dystrophy
Enrollment
65 pts
Location
United States, Canada
Sponsor
REGENXBIO Inc.
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NCT06844357 Phase 2, Phase 3
Recruiting
A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) Wi...
Condition
HCC
Enrollment
300 pts
Location
China
Sponsor
Zhejiang Raygene Pharmaceutica
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NCT04984512 Phase 2, Phase 3
Recruiting
The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Pati...
Condition
Depressive Disorder, Major
Enrollment
600 pts
Location
China
Sponsor
Sunshine Lake Pharma Co., Ltd.
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NCT06589505 Phase 2, Phase 3
Recruiting
Software as a Medical Device for the Treatment of Patients With PTSD
Condition
Post-Traumatic Stress Disorder, PTSD
Enrollment
52 pts
Location
Japan
Sponsor
Otsuka Medical Devices Co., Lt
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NCT07293468 Phase 2, Phase 3
Recruiting
Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectab...
Condition
Hepatocellular Carcinoma (HCC)
Enrollment
106 pts
Location
Hong Kong
Sponsor
Tuen Mun Hospital
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NCT06196515 Phase 2, Phase 3
Recruiting
Anti-bacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication
Condition
Endodontic Disease
Enrollment
54 pts
Location
Egypt
Sponsor
British University In Egypt
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NCT02314988 Phase 2, Phase 3
Recruiting
Tranexamic Acid to Reduce Blood Loss in Spine Surgery
Condition
Spinal Injuries
Enrollment
252 pts
Location
United States
Sponsor
Columbia University
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NCT05714085 Phase 2, Phase 3
Recruiting
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants W...
Condition
Heart Failure
Enrollment
342 pts
Location
United States, Belgium, Brazil
Sponsor
Merck Sharp & Dohme LLC
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NCT06280495 Phase 2, Phase 3
Recruiting
Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF W...
Condition
Colorectal Cancer
Enrollment
156 pts
Location
China
Sponsor
Sun Yat-sen University
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NCT05689034 Phase 2, Phase 3
Recruiting
Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvu...
Condition
COVID-19 Respiratory Infection
Enrollment
1,096 pts
Location
China
Sponsor
Peking Union Medical College H
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NCT06441006 Phase 2, Phase 3
Recruiting
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculos...
Condition
Tuberculosis, Pulmonary
Enrollment
400 pts
Location
Mongolia, Pakistan, Peru
Sponsor
University of California, San
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NCT05587036 Phase 2, Phase 3
Recruiting
Effects of Rifaximin on Gut Microbiota and Emotion
Condition
Healthy Volunteers
Enrollment
60 pts
Location
Belgium
Sponsor
Universitaire Ziekenhuizen KU
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NCT06477536 Phase 2, Phase 3
Recruiting
Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Ps...
Condition
Generalized Pustular Psoriasis
Enrollment
33 pts
Location
China
Sponsor
Shanghai Huaota Biopharmaceuti
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NCT04093167 Phase 2, Phase 3
Recruiting
Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer
Condition
Lung Cancer
Enrollment
230 pts
Location
United States, Canada
Sponsor
Canadian Cancer Trials Group
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NCT06896981 Phase 2, Phase 3
Recruiting
Semaglutide in Women With Polycystic Ovary Syndrome and Obesity
Condition
Polycystic Ovary Syndrome (PCOS) Women
Enrollment
30 pts
Location
Bangladesh
Sponsor
Bangabandhu Sheikh Mujib Medic
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NCT07589244 Phase 2, Phase 3
Recruiting
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
Condition
HCC
Enrollment
66 pts
Location
China
Sponsor
Guangzhou Virotech Pharmaceuti
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Page 4 of 5 — 122 trials total
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