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
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
NCT05076175 Phase 2, Phase 3
Recruiting
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Mod...
Condition
Colitis, Ulcerative
Enrollment
120 pts
Location
United States, Australia, Belgium
Sponsor
Bristol-Myers Squibb
NCT06201611 Phase 2, Phase 3
Recruiting
Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients...
Condition
Diabetic Neuropathy Peripheral
Enrollment
120 pts
Location
India
Sponsor
St. John's Research Institute
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
NCT07290595 Phase 2, Phase 3
Recruiting
Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%...
Condition
Post Operative Analgesia
Enrollment
66 pts
Location
Pakistan
Sponsor
Sahiwal medical college sahiwa
NCT07472153 Phase 2, Phase 3
Recruiting
PD-1 (Programmed Death-1) Versus PD-L1 (Programmed Death-ligand 1) Immune Check ...
Condition
Metastatic Cervical Cancer
Enrollment
120 pts
Location
Belarus
Sponsor
N.N. Alexandrov National Cance
NCT07642024 Phase 2, Phase 3
Recruiting
A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in ...
Condition
Non-small Cell Lung Cancer
Enrollment
90 pts
Location
China
Sponsor
Sichuan Baili Pharmaceutical C
NCT04201015 Phase 2, Phase 3
Recruiting
Optimising Pacing for Contractility 2
Condition
Heart Failure, Systolic
Enrollment
400 pts
Location
United Kingdom
Sponsor
University of Leeds
NCT07294508 Phase 2, Phase 3
Recruiting
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positi...
Condition
HER2 + Breast Cancer
Enrollment
706 pts
Location
China
Sponsor
Shanghai Henlius Biotech
NCT06595355 Phase 2, Phase 3
Recruiting
Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Or...
Condition
Diabetic Macular Edema
Enrollment
52 pts
Location
Iran
Sponsor
Isfahan University of Medical
NCT07669584 Phase 2, Phase 3
Recruiting
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Condition
Infertility Due to Azoospermia
Enrollment
732 pts
Location
Spain
Sponsor
Prokrea BCN, S.L.
NCT04910685 Phase 2, Phase 3
Recruiting
(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Pati...
Condition
Indolent Systemic Mastocytosis
Enrollment
534 pts
Location
United States, Argentina, Australia
Sponsor
Blueprint Medicines Corporatio
NCT05517434 Phase 2, Phase 3
Recruiting
Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA
Condition
Osteoarthritis, Knee
Enrollment
148 pts
Location
Canada
Sponsor
University Health Network, Tor
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
NCT06862596 Phase 2, Phase 3
Recruiting
Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atroph...
Condition
Spinal and Bulbar Muscular Atrophy
Enrollment
68 pts
Location
Japan
Sponsor
Masahisa Katsuno
NCT06109272 Phase 2, Phase 3
Recruiting
A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Li...
Condition
Hepatocellular Carcinoma
Enrollment
660 pts
Location
United States, France, Italy
Sponsor
AbbVie
NCT07399587 Phase 2, Phase 3
Recruiting
Optimizing HFrEF Patients Using BaroStim and CardioMems
Condition
Heart Failure NYHA Class III
Enrollment
15 pts
Location
United States
Sponsor
Northwell Health
NCT06193889 Phase 2, Phase 3
Recruiting
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patien...
Condition
Myasthenia Gravis
Enrollment
66 pts
Location
United States, Australia, Brazil
Sponsor
Kyverna Therapeutics
NCT04748640 Phase 2, Phase 3
Recruiting
Bilateral Essential Tremor Treatment With Gamma Knife
Condition
Essential Tremor
Enrollment
50 pts
Location
Canada
Sponsor
Université de Sherbrooke
NCT06556550 Phase 2, Phase 3
Recruiting
Stereotactic Radiotherapy for Oligometastasis (1-5) in Various Tumor Sites vs. P...
Condition
Oligometastatic Disease
Enrollment
100 pts
Location
Russia
Sponsor
National Medical Research Radi
NCT07459790 Phase 2, Phase 3
Recruiting
The Study is Being Conducted to Find a New Treatment for Patients Suffering From...
Condition
IC
Enrollment
180 pts
Location
Russia
Sponsor
JSC NextGen
NCT07472491 Phase 2, Phase 3
Recruiting
A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhan...
Condition
Known or Highly Suspected Central Nervous System (CNS) Lesion
Enrollment
640 pts
Location
United States, Georgia, Moldova
Sponsor
GE Healthcare
NCT06616584 Phase 2, Phase 3
Recruiting
Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Adva...
Condition
Recurrent Lung Non-Small Cell Carcinoma
Enrollment
378 pts
Location
United States
Sponsor
SWOG Cancer Research Network
NCT03660917 Phase 2, Phase 3
Recruiting
Riluzole in Patients With Spinocerebellar Ataxia Type 7
Condition
SCA7
Enrollment
34 pts
Location
Italy
Sponsor
S. Andrea Hospital
NCT06519955 Phase 2, Phase 3
Recruiting
Can PLIA Reduce Early Post-operative Pain After PAO Surgery?
Condition
Hip Dysplasia
Enrollment
120 pts
Location
United States
Sponsor
Michael C Willey
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