Phase 3 Clinical Trials in 2022

2022 Phase 3 Research Overview

Phase 3 clinical trials started in 2022 provide a snapshot of the medical research landscape. In total, 46 such trials were initiated. 11 of these are still actively recruiting. 7 trials have been completed. Leading sponsors include Eli Lilly and Company, AstraZeneca, Janssen Research & Development, LLC.

46

Phase 3 Trials

11

Recruiting

10

Sponsors

Trial Status

ACTIVE NOT RECRUITING: 20 trials
RECRUITING: 11 trials
COMPLETED: 7 trials
TERMINATED: 4 trials
SUSPENDED: 3 trials
UNKNOWN: 1 trial

Top Sponsors (2022)

Eli Lilly and Company (5 trials)
AstraZeneca (4 trials)
Janssen Research & Development, LLC (3 trials)
Pfizer (3 trials)
National Cancer Institute (NCI) (3 trials)
Hoffmann-La Roche (3 trials)
AbbVie (2 trials)
Novartis Pharmaceuticals (2 trials)
Biofrontera Inc. (1 trial)
University Hospital, Montpellier (1 trial)

Phase 3 Trials Started in 2022

An Open-Label Study to Evaluate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

NCT05369403 · COMPLETED · Phase 3 · Eli Lilly and Company

A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp

NCT05662202 · ACTIVE NOT RECRUITING · Phase 3 · Biofrontera Inc.

A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

NCT05550532 · COMPLETED · Phase 3 · Janssen Research & Development, LLC

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

NCT05629585 · ACTIVE NOT RECRUITING · Phase 3 · AstraZeneca

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)

NCT05601882 · COMPLETED · Phase 3 · AbbVie

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis. A Randomized Controlled Trial With an Independent Efficacy Assessor.

NCT05428488 · RECRUITING · Phase 3 · University Hospital, Montpellier

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Active Psoriatic Arthritis

NCT05623345 · TERMINATED · Phase 3 · ACELYRIN Inc.

AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA

NCT05623020 · RECRUITING · Phase 3 · Pfizer

Phase II/III Parallel, Double-blind, Non-inferiority Study With Active Control, to Evaluate the Immunogenicity and Safety of a Booster Immunization Scheme With a Single Intramuscular Dose of the Recombinant Vaccine Against SARS-CoV-2

NCT05710783 · COMPLETED · Phase 3 · Laboratorio Avi-Mex, S.A. de C.V.

A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

NCT05485961 · RECRUITING · Phase 3 · CSL Behring

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity

NCT05556512 · ACTIVE NOT RECRUITING · Phase 3 · Eli Lilly and Company

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

NCT05508789 · ACTIVE NOT RECRUITING · Phase 3 · Eli Lilly and Company

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

NCT05507203 · COMPLETED · Phase 3 · Abivax S.A.

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without Radiation Therapy for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

NCT04929041 · SUSPENDED · Phase 3 · National Cancer Institute (NCI)

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

NCT05514054 · ACTIVE NOT RECRUITING · Phase 3 · Eli Lilly and Company

The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital.

NCT06698666 · RECRUITING · Phase 3 · Ain Shams University

Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Abatacept in Combination With a Janus Kinase (JAK) Inhibitor

NCT05451615 · UNKNOWN · Phase 3 · Zhejiang Provincial People's Hospital

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Basket Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis

NCT05503264 · RECRUITING · Phase 3 · Hoffmann-La Roche

EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

NCT06486142 · RECRUITING · Phase 3 · Region Skane

A Randomized, Parallel-controlled, Open-label, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of D-0502 With Fulvestrant in Patients With Previously Treated ER-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

NCT06954961 · RECRUITING · Phase 3 · InventisBio Co., Ltd

A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin

NCT05317858 · RECRUITING · Phase 3 · InSightec

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

NCT05388669 · ACTIVE NOT RECRUITING · Phase 3 · Janssen Research & Development, LLC

A Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-2)

NCT05349214 · ACTIVE NOT RECRUITING · Phase 3 · Novartis Pharmaceuticals

A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

NCT05261399 · ACTIVE NOT RECRUITING · Phase 3 · AstraZeneca

Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease

NCT05463731 · ACTIVE NOT RECRUITING · Phase 3 · Eli Lilly and Company

A Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)

NCT05350072 · ACTIVE NOT RECRUITING · Phase 3 · Novartis Pharmaceuticals

Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)

NCT05058651 · RECRUITING · Phase 3 · National Cancer Institute (NCI)

An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 2 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)

NCT05143177 · SUSPENDED · Phase 3 · REDNVIA Co., Ltd.

A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

NCT05455684 · COMPLETED · Phase 3 · Janssen Research & Development, LLC

A Phase III, Single-Arm Multicenter Study of Atezolizumab (Anti-PD-L1 Antibody) in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

NCT05047250 · ACTIVE NOT RECRUITING · Phase 3 · Hoffmann-La Roche

MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial Cancer

NCT05092958 · ACTIVE NOT RECRUITING · Phase 3 · National Cancer Institute (NCI)

The Use of Empagliflozin in Patients With Hypertrophic Cardiomyopathy

NCT05182658 · ACTIVE NOT RECRUITING · Phase 3 · National Institute of Cardiology, Warsaw, Poland

Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial (IMAGINE)

NCT04637594 · ACTIVE NOT RECRUITING · Phase 3 · Alliance for Clinical Trials in Oncology

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

NCT05374512 · ACTIVE NOT RECRUITING · Phase 3 · AstraZeneca

A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of Administration

NCT05265728 · TERMINATED · Phase 3 · Biogen

A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease

NCT05256134 · TERMINATED · Phase 3 · Hoffmann-La Roche

An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial

NCT05348915 · TERMINATED · Phase 3 · Pfizer

A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

NCT05317416 · ACTIVE NOT RECRUITING · Phase 3 · Pfizer

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

NCT04928846 · RECRUITING · Phase 3 · AbbVie

A Phase III,Randomized, Double-blind, Paralle, Multi-center Study to Evaluate the Efficacy and Safety of TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Participants With Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor(EGFR) 2-Negative Advanced Breast Cancer

NCT05375461 · COMPLETED · Phase 3 · Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

NCT05132582 · ACTIVE NOT RECRUITING · Phase 3 · Seagen, a wholly owned subsidiary of Pfizer

Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors (TKIs) in Patients With Advanced Non-small Cell Lung Cancer

NCT05852990 · RECRUITING · Phase 3 · Instituto Nacional de Cancerologia de Mexico

Pilot Randomized Feasibility Trial of Tele-Interpersonal Psychotherapy and Tele-Pharmacotherapy for Depression in Patients With Non-Metastatic Breast Cancer

NCT04973930 · SUSPENDED · Phase 3 · New York State Psychiatric Institute

A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib Versus Placebo in Participants With EGFR Mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, Following Complete Tumour Resection

NCT05120349 · ACTIVE NOT RECRUITING · Phase 3 · AstraZeneca

A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies

NCT04851613 · ACTIVE NOT RECRUITING · Phase 3 · Laekna Limited

A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T Versus Hormone Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT05204927 · ACTIVE NOT RECRUITING · Phase 3 · Curium US LLC

Frequently Asked Questions

How many Phase 3 trials started in 2022?

46 Phase 3 clinical trials were started in 2022 according to ClinicalTrials.gov data tracked by ReadTheTrial.

What is Phase 3 in clinical trials?

Phase 3 trials are large-scale pivotal studies with 300-3,000+ participants for FDA approval.

Are any 2022 Phase 3 trials recruiting?

Yes, 11 Phase 3 trials from 2022 are still recruiting.

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