Monoclonal Antibody Biosimilars
Total Trials
87
As Lead Sponsor
75
As Collaborator
12
Total Enrollment
28,513
NCT01084863
Evaluate Safety, Efficacy and Pharmacokinetics
Phase: Phase 1/2
Role: Lead Sponsor
Start: Feb 28, 2010
Completion: Dec 31, 2023
NCT01084876
Demonstrate Efficacy and Safety of Metastatic Breast Cancer
Phase: Phase 3
Start: Jun 30, 2010
Completion: Mar 31, 2015
NCT01217086
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)
Start: Oct 31, 2010
Completion: Jul 31, 2012
NCT01220518
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)
Phase: Phase 1
Completion: Jun 30, 2012
NCT01534884
Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis
Start: Feb 29, 2012
Completion: Feb 28, 2014
NCT01534949
Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial
Completion: Feb 28, 2013
NCT01571206
An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1
Start: Mar 31, 2012
Completion: May 31, 2013
NCT01571219
An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1
Completion: Jul 31, 2013
NCT01873443
Long-Term Efficacy and Safety of CT-P10 in Patients With RA
Start: May 31, 2013
Completion: Oct 31, 2014
NCT02557295
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA
Phase: N/A
Start: Dec 17, 2013
Completion: Mar 2, 2020
NCT02071914
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Phase: Phase 2
Start: Feb 15, 2014
Completion: Jun 19, 2014
NCT02162667
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Start: Jun 30, 2014
Completion: Oct 31, 2018
NCT02162771
To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
Start: Jul 14, 2014
Completion: Dec 29, 2018
NCT02149121
PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis
Start: Aug 31, 2014
Completion: Jan 31, 2017
NCT02096861
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
Start: Sep 19, 2014
Completion: Feb 15, 2017
NCT02326155
To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)
Start: Dec 8, 2014
Completion: Feb 28, 2020
NCT02557308
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
Start: May 26, 2015
Completion: Feb 28, 2021
NCT02260804
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Start: Nov 9, 2015
Completion: Sep 4, 2019
NCT02665637
Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin
Start: Dec 31, 2015
Completion: Apr 30, 2016
NCT02579733
Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
Phase: Phase 4
Role: Collaborator
Start: Feb 1, 2016
Completion: Dec 1, 2018
NCT03147248
A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA
Start: Sep 12, 2016
Completion: Apr 15, 2019
NCT02883452
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
Start: Sep 29, 2016
Completion: Oct 2, 2019
NCT03511066
A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection
Start: Dec 9, 2016
Completion: Jun 15, 2018
NCT03247673
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
Start: Aug 7, 2017
Completion: Jan 17, 2018
NCT03446976
CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects
Start: Feb 21, 2018
Completion: Jul 26, 2018
NCT03588533
Herzuma-capecitabine/Cisplatin for Gastric Cancer
Start: Jun 10, 2018
Completion: Aug 31, 2021
NCT03707535
To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
Start: Nov 12, 2018
Completion: Mar 5, 2021
NCT03789292
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Start: Nov 26, 2018
Completion: Apr 24, 2020
NCT03569995
[CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma
Start: Nov 30, 2018
Completion: Jun 30, 2025
NCT03676192
To Compare Efficacy and Safety of CT-P16 and European Union-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
Start: Feb 1, 2019
Completion: Sep 19, 2023
NCT03918967
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
Start: Apr 8, 2019
Completion: Jun 6, 2020
NCT03970824
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
Start: May 31, 2019
Completion: Jan 15, 2020
NCT04295356
To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17
Start: Jun 21, 2019
Completion: Nov 15, 2019
NCT04171414
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Start: Sep 9, 2019
NCT03945019
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
Start: Oct 28, 2019
Completion: Aug 22, 2023
NCT04018313
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Start: May 28, 2020
Completion: Apr 30, 2021
NCT04525079
To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects
Start: Jul 18, 2020
Completion: Nov 5, 2020
NCT04428814
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects
Start: Aug 3, 2020
Completion: Feb 24, 2021
NCT04205643
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
Start: Sep 1, 2020
Completion: Jul 11, 2023
NCT04593641
This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)
Start: Sep 4, 2020
Completion: Apr 5, 2021
NCT04602000
A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 Infection
Phase: Phase 2/3
Start: Oct 5, 2020
Completion: Oct 20, 2021
NCT04512872
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Start: Oct 20, 2020
Completion: May 4, 2021
NCT04418297
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy
Start: Oct 23, 2020
Completion: Nov 22, 2022
NCT04627753
Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.
Start: Nov 2, 2020
Completion: Nov 2, 2026
NCT04426890
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
Start: Dec 9, 2020
Completion: Apr 27, 2023
NCT04673786
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Start: Jan 11, 2021
Completion: May 12, 2022
NCT04757376
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
Start: Jun 17, 2021
Completion: Nov 16, 2023
NCT04922827
Infliximab in the Treatment of Patients With Severe COVID-19 Disease
Start: Jun 18, 2021
Completion: Jul 1, 2023
NCT04739306
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Start: Jul 22, 2021
Completion: Apr 24, 2023
NCT05002244
A Drug-Drug Interaction Study of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers
Start: Jul 23, 2021
Completion: Sep 13, 2021
NCT05009368
A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult Volunteers
Completion: Oct 15, 2021
NCT04990258
A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Start: Sep 6, 2021
Completion: Sep 30, 2024
NCT06037395
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Start: Oct 6, 2021
Completion: Oct 20, 2022
NCT05017168
To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects
Start: Oct 11, 2021
Completion: Jan 25, 2022
NCT06059989
InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease
Start: Nov 25, 2021
Completion: Dec 31, 2025
NCT05072782
Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)
Start: Dec 21, 2021
Completion: Jun 15, 2024
NCT05188378
A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Start: Dec 22, 2021
Completion: Jan 31, 2023
NCT05224856
To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen
Start: Apr 30, 2022
NCT05363384
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers
Start: Jun 11, 2022
Completion: Jul 12, 2022
NCT05363592
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers
Start: Jun 25, 2022
Completion: Jul 25, 2022
NCT05385770
Study to Evaluate and Compare the Efficacy and Safety of AZM and AML Combined and Alone in Mild-to-moderate Essential Hypertensive Subjects
Start: Jul 8, 2022
Completion: Jul 19, 2024
NCT05364164
A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers
Start: Jul 9, 2022
NCT05568121
A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy Volunteers
Start: Sep 1, 2022
Completion: Oct 27, 2022
NCT05489224
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
Start: Sep 14, 2022
Completion: Nov 23, 2023
NCT05581693
A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers
Start: Sep 30, 2022
Completion: Nov 29, 2022
NCT05495568
To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis
Start: Nov 7, 2022
Completion: Feb 5, 2024
NCT05617183
Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects
Start: Nov 15, 2022
Completion: Sep 30, 2023
NCT05866614
A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps
Start: Jan 13, 2023
Completion: Mar 31, 2027
NCT05725434
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis
Start: Feb 6, 2023
Completion: Jul 31, 2023
NCT05993806
A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers
Start: Jun 2, 2023
Completion: Jun 29, 2023
NCT05906992
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis
Start: Jan 11, 2024
Completion: Jan 31, 2029
NCT07054970
To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects
Start: Jan 12, 2024
Completion: Sep 6, 2024
NCT06113913
Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Start: Apr 9, 2024
Completion: Nov 30, 2026
NCT06571591
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin with Metformin
Start: Aug 27, 2024
Completion: May 31, 2026
NCT06627322
A Registry-based Randomized Controlled Trial in Type 2 Diabetes With Cardiovascular Risk Factors (REMATCH)
Start: Nov 21, 2024
Completion: Sep 30, 2029
NCT06989723
Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes
Start: Jan 1, 2025
Completion: Jun 30, 2027
NCT06738719
A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis
Start: Jan 3, 2025
Completion: Apr 15, 2026
NCT06939595
A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer
Start: Jan 30, 2025
Completion: Jul 31, 2028
NCT06687928
To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)
Start: Mar 25, 2025
Completion: Aug 5, 2025
NCT06630559
A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Psoriasis
Start: Apr 30, 2025
Completion: Aug 31, 2026
NCT06951828
A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects
Start: May 30, 2025
Completion: Apr 30, 2026
NCT07093476
Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
Start: Jul 18, 2025
Completion: Apr 30, 2027
NCT07013578
TIDHI Mental Health in IBD Patients Study
Start: Jul 22, 2025
Completion: Jul 1, 2027
NCT06952478
A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma
Start: Aug 12, 2025
Completion: Jun 25, 2029
NCT07158346
Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of CT-L03 in Healthy Volunteers
Start: Aug 18, 2025
Completion: Oct 31, 2025
NCT07128654
A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
Start: Aug 31, 2025
NCT07200986
Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
Start: Sep 17, 2025
Completion: Mar 31, 2026
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