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
119
Recruiting Now
119
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
NCT07426094 Phase 2, Phase 3
Recruiting
PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation i...
Condition
Prostate Cancer
Enrollment
600 pts
Location
Poland
Sponsor
Affidea Nu-med Center of Oncol
NCT05413122 Phase 2, Phase 3
Recruiting
Evaluating Smoking Cessation Interventions for PWH in South Africa
Condition
Smoking Cessation
Enrollment
660 pts
Location
South Africa
Sponsor
Johns Hopkins University
NCT06647498 Phase 2, Phase 3
Recruiting
A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or...
Condition
Alzheimers Disease
Enrollment
280 pts
Location
United States, Argentina, Australia
Sponsor
Washington University School o
NCT05047133 Phase 2, Phase 3
Recruiting
Effect of Early Administration of TXA in Adult Hip Fractures
Condition
Postoperative Blood Loss
Enrollment
170 pts
Location
United States
Sponsor
Ascension Health
NCT06721949 Phase 2, Phase 3
Recruiting
Taurine Supplementation in Long COVID
Condition
Long COVID
Enrollment
300 pts
Location
Canada
Sponsor
University of Alberta
NCT07426055 Phase 2, Phase 3
Recruiting
PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Stage...
Condition
Prostate Cancer (Adenocarcinoma)
Enrollment
1,000 pts
Location
Poland
Sponsor
Affidea Nu-med Center of Oncol
NCT03150576 Phase 2, Phase 3
Recruiting
Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadj...
Condition
Breast Cancer
Enrollment
780 pts
Location
United Kingdom
Sponsor
Cambridge University Hospitals
NCT06756152 Phase 2, Phase 3
Recruiting
Preventing of GVHD with Post-transplantation Cyclophosphamide, Abatacept, Vedoli...
Condition
Biphenotypic Acute Leukemia
Enrollment
50 pts
Location
Russia
Sponsor
Federal Research Institute of
NCT05893888 Phase 2, Phase 3
Recruiting
A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subj...
Condition
Oral Squamous Cell Carcinoma
Enrollment
40 pts
Location
United States
Sponsor
Privo Technologies
NCT07063576 Phase 2, Phase 3
Recruiting
Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Diseas...
Condition
GERD - PPI Non-responders
Enrollment
60 pts
Location
Bangladesh
Sponsor
Adnan Imtiaj Rahul
NCT06563245 Phase 2, Phase 3
Recruiting
Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Asse...
Condition
Classical Hodgkin Lymphoma
Enrollment
96 pts
Location
China
Sponsor
Children's Cancer Group, China
NCT06644937 Phase 2, Phase 3
Recruiting
Single-arm Clinical Trial of TACE in Combination With Icaritin as Adjuvant Thera...
Condition
Hepatocellular Carcinoma (HCC)
Enrollment
30 pts
Location
China
Sponsor
Zhujiang Hospital
NCT04833894 Phase 2, Phase 3
Recruiting
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Ad...
Condition
Generalized Myasthenia Gravis
Enrollment
12 pts
Location
United States, Austria, Belgium
Sponsor
argenx
NCT07323329 Phase 2, Phase 3
Recruiting
Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization
Condition
Infertility
Enrollment
165 pts
Location
Egypt
Sponsor
Beni-Suef University
NCT06559995 Phase 2, Phase 3
Recruiting
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in ...
Condition
Alcohol Use Disorder
Enrollment
30 pts
Location
United States
Sponsor
University of Pennsylvania
NCT07404553 Phase 2, Phase 3
Recruiting
A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Li...
Condition
Hypercholesterolemia
Enrollment
126 pts
Location
China
Sponsor
Beijing Suncadia Pharmaceutica
NCT07505472 Phase 2, Phase 3
Recruiting
Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX C...
Condition
Rectal Cancer
Enrollment
212 pts
Location
China
Sponsor
The First Hospital of Jilin Un
NCT07204457 Phase 2, Phase 3
Recruiting
Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Health...
Condition
Meningococcal Infections
Enrollment
1,123 pts
Location
South Korea
Sponsor
EyeGene Inc.
NCT03951194 Phase 2, Phase 3
Recruiting
Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal W...
Condition
Infertility, Female
Enrollment
100 pts
Location
Greece
Sponsor
Genesis Athens Clinic
NCT05334485 Phase 2, Phase 3
Recruiting
Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surge...
Condition
Postoperative Ileus
Enrollment
50 pts
Location
United States
Sponsor
Stefan Holubar MD MS FACS, FAS
NCT04912843 Phase 2, Phase 3
Recruiting
Gene Therapy Clinical Trial for the Treatment Of Leber's HereDitary Optic Neurop...
Condition
Leber's Hereditary Optic Neuropathy (LHON)
Enrollment
102 pts
Location
China
Sponsor
Wuhan Neurophth Biotechnology
NCT07199504 Phase 2, Phase 3
Recruiting
A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia Wit...
Condition
Restless Leg Syndrome Due to Uraemia
Enrollment
80 pts
Location
China
Sponsor
Yunfeng Xia
NCT06493552 Phase 2, Phase 3
Recruiting
Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
Condition
Muscle-Invasive Bladder Carcinoma
Enrollment
700 pts
Location
United States
Sponsor
Vasgene Therapeutics, Inc
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
NCT06085716 Phase 2, Phase 3
Recruiting
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cance...
Condition
Metastatic Cancers
Enrollment
240 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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