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KRW · as of 2026-08-18 · marketstack
Clinical trials
catalyst calendar across sponsors →Studies where 068270.KS is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
73 interventional · 4 observational · 31 with posted results
Held by 0 tracked-famous managers · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| 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 MyelomaNCT06952478PK equivalence of CT-P44 and Darzalex FasproRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Biological: CT-P44(Daratumumab), Darzalex Faspro(Daratumumab) | Refractory or Relapsed Multiple Myeloma | 486 | 2027-11-15 | in 453 d | 2025-08-15 |
| A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and PsNCT05866614observationalevaluation of adverse events of special interest (AESI) | — | Active, not recruiting | Drug: Remsima IV, Remsima SC | Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis | 881 | Mar 2027 | ≤ 224 d | 2026-03-31 |
| A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple SclerosisNCT05906992Area under the concentration-time curve in PK groupRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Biological: CT-P53, US-Ocrevus, EU-Ocrevus | Relapsing-remitting Multiple Sclerosis | 512 | Feb 2027 | ≤ 193 d | 2024-05-22 |
| A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung CancerNCT06939595ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: CT-P51, EU-approved Keytruda | Non Squamous Non Small Cell Lung Cancer | 225 | Feb 2027 | ≤ 193 d | 2026-07-08 |
| Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and MetforminNCT07093476HbA1cRandomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Metformin, Alogliptin, empagliflozin | T2DM, Diabete Type 2, DM | 171 | Dec 2026 | ≤ 134 d | 2025-08-11 |
| Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy SubjectsNCT07200986AUC0-infRandomized · Quadruple-masked · Treatment | Phase 1 | Active, not recruiting | Biological: Ixekizumab | Healthy Participants | 218 | 2026-03-31 | — | 2025-12-31 |
| A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe PsoriasisNCT06630559Percent change from baseline in Psoriasis Area and Severity Index (PASI) scoreRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Biological: CT-P55, EU-approved Cosentyx | Plaque Psoriasis | 153 | 2026-02-18actual | — | 2026-02-23 |
| A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male SubjectsNCT07367958PK similarity demonstration by AUC 0-infRandomized · Open-label · Other | Phase 1 | Completed | Biological: CT-P52 | Healthy Male Subjects | 218 | 2026-07-01actual | — | 2026-07-17 |
| Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of L03TD1 in Healthy VolunteersNCT07533539AUCtRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: L03RD1, L03RD2, L03TD1 | Type 2 Diabetes Mellitus (T2DM) | 48 | 2026-05-28actual | — | 2026-07-28 |
| Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With MetforminNCT06571591HbA1cRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: CT-L03 Group 1, CT-L03 Group 2, Placebo, Empagliflozin, Metformin | T2DM | 606 | 2026-04-16actual | — | 2026-05-15 |
| A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male SubjectsNCT06951828PK similarity demonstration by AUC 0-infRandomized · Open-label · Other | Phase 1 | Completed | Biological: CT-P43, CT-P43 | Healthy Male Subjects | 162 | 2025-11-26actual | — | 2026-02-24 |
| A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy VolunteersNCT07128654AUCt (Area under the plasma concentration-time curve)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CTL02, CTL0201, CTL0202 | Healthy | 40 | 2025-10-05actual | — | 2025-11-17 |
| Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of CT-L03 in Healthy VolunteersNCT07158346AUCtRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: L03RD1, L03RD2, CT-L03 | Type 2 Diabetes Mellitus (T2DM) | 49 | 2025-10-03actual | — | 2025-11-21 |
| To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)NCT06687928Demonstrate PK similarityRandomized · Triple-masked · Treatment | Phase 1 | Completed | Biological: CT-P6 SC, EU-Approved Herceptin SC | Healthy | 200 | 2025-08-05actual | — | 2026-04-23 |
| A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid ArthritisNCT06738719Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Biological: CT-P13 SC Auto-Injector, Placebo Auto-Injector | Moderately to Severely Active Rheumatoid Arthritis | 192 | 2025-06-25actual | — | 2026-04-23 |
| To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy SubjectsNCT07054970Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)Randomized · Quadruple-masked · Other | Phase 1 | Completed | Biological: CT-P55, US-licensed Cosentyx, EU-approved Cosentyx | Healthy Male Subjects | 172 | 2024-08-29actual | — | 2025-07-08 |
| Study to Evaluate and Compare the Efficacy and Safety of AZM and AML Combined and Alone in Mild-to-moderate Essential Hypertensive SubjectsNCT05385770msitSBPRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: AZM X mg + AML Y mg, AZM X mg + AML Y' mg, AZM X' mg + AML Y mg, AZM X' mg + AML Y' mg, AZM X mg, AZM X' mg, AML Y mg, AML Y' mg | Essential Hypertension | 890 | 2024-07-11actual | — | 2025-09-11 |
| To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque PsoriasisNCT05495568To demonstrate the pharmacokinetics (PK) similarity between patients receiving Humira continuously and those who alternate between Humira and CT-P17 in terms of Area under the concentration-time curve over the dosing interval (AUCtau, 25-27)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Biological: CT-P17, EU-approved Humira | Moderate to Severe Chronic Plaque Psoriasis | 367 | 2023-08-14actual | — | 2024-08-21 |
| A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid ArthritisNCT05489224results2024-10-08Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P47, EU-approved RoActemra | Rheumatoid Arthritis | 471 | 2023-06-29actual | — | 2024-10-08 |
| A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy VolunteersNCT05993806AUCtRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: L04RD1, L04TD3 | Essential Hypertension | 50 | 2023-06-12actual | — | 2023-08-15 |
| A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With OsteoporosisNCT04757376results2024-05-16Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P41, US-licensed Prolia | Postmenopausal Women With Osteoporosis | 479 | 2023-05-18actual | — | 2024-06-14 |
| Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy SubjectsNCT05617183PK similarity demonstration by AUCRandomized · Open-label · Other | Phase 1 | Unknown status | Biological: CT-P47, CT-P47 | Healthy Subjects | 268 | Apr 2023 | — | 2023-03-27 |
| A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid ArthritisNCT05725434The usability of AI as assessed by patients rating using POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 2.Open-label · Treatment | Phase 3 | Unknown status | Biological: CT-P47 AI (tocilizumab), CT-P47 PFS (tocilizumab) | Rheumatoid Arthritis | 30 | 2023-04-01 | — | 2023-02-16 |
| To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental OxygenNCT05224856Time to clinical recoveryRandomized · Quadruple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: The sponsor has decided to stop development of the inhaled CT-P63/66 combination therapy. | Biological: CT-P63 and CT-P66 / Placebo | COVID-19 | 0 | Nov 2022 | — | 2022-07-25 |
| A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic CardiomyopathyNCT04418297Incidence and severity of treatment-emergent adverse events and their relationship to the investigational productRandomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: The termination criteria of the protocol was met during dose escalation | Drug: CT-G20, Placebo | Cardiomyopathy, Hypertrophic Obstructive | 23 | 2022-11-22actual | — | 2023-03-02 |
| A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy VolunteersNCT05581693AUCtRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: L04RD1, L04TD2, L04TD2, L04RD1 | Healthy | 50 | 2022-11-01actual | — | 2023-01-12 |
| To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous UrticariaNCT04426890results2025-07-29Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg GroupsRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P39, EU-approved Xolair | Chronic Spontaneous Urticaria | 634 | 2022-10-21actual | — | 2025-07-29 |
| Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male SubjectsNCT06037395AUCinfRandomized · Quadruple-masked · Other | Phase 1 | Completed | Biological: CT-P41, US-licensed Prolia | Healthy Subject | 154 | 2022-10-20actual | — | 2023-09-14 |
| Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular EdemaNCT04739306results2023-12-05Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P42, Eylea | Diabetic Macular Edema (DME) | 348 | 2022-10-14actual | — | 2023-12-05 |
| A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy VolunteersNCT05568121AUCtRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: L04RD1, L04TD1, L04TD1, L04RD1 | Healthy | 50 | 2022-10-09actual | — | 2023-01-12 |
| A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy SubjectsNCT05188378Primary objectiveRandomized · Quadruple-masked · Other | Phase 1 | Unknown status | Biological: CT-P47, EU-approved RoActemra, | Healthy Subjects | 300 | 2022-10-01 | — | 2022-01-12 |
| CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)NCT03945019results2023-10-23Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P13 SC (Infliximab) · Other: Placebo SC | Crohn's Disease | 396 | 2022-08-23actual | — | 2023-10-23 |
| A Food Effect Study of CT-L01 After Oral Administration in Healthy VolunteersNCT05364164AUClast (Area under the plasma concentration-time curve)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CT-L01 12.5/1,000 mg, CT-L01 12.5/1,000 mg | Healthy | 24 | 2022-07-19actual | — | 2023-01-12 |
| CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)NCT04205643results2023-09-28Percentage of Patients Achieving Clinical Remission at Week 54Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P13 SC (Infliximab) · Other: Placebo SC | Ulcerative Colitis | 548 | 2022-07-07actual | — | 2023-09-28 |
| A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy VolunteersNCT05363592AUClast (Area under the plasma concentration-time curve)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CT-L01 12.5/500 mg, Alogliptin Benzoate 12.5 mg, Metformin HCl XR 500 mg | Healthy | 48 | 2022-07-05actual | — | 2023-01-12 |
| A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy VolunteersNCT05363384AUClast (Area under the plasma concentration-time curve)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CT-L01, Alogliptin Benzoate 25 mg, Metformin HCl XR 1,000 mg | Healthy | 48 | 2022-06-21actual | — | 2023-01-12 |
| To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy SubjectsNCT05017168To evaluate safety and tolerability of single ascending dose of CT-P63:Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: CT-P63, Placebo | SARS-CoV-2 Infection | 24 | 2021-11-12actual | — | 2022-08-11 |
| A Drug-Drug Interaction Study of CTL0901 and CTL0902 Compared to Coadministration in Healthy Adult VolunteersNCT05009368AUCτ,ssNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Drug: Treatment A, Drug: Treatment B, Drug: Treatment C | Health, Subjective | 41 | 2021-10-08actual | — | 2021-12-23 |
| A Drug-Drug Interaction Study of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult VolunteersNCT05002244AUCτ,ssNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CTL0801 (Azilsartan), CTL0802 (Rosuvastatin), CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin) | Health, Subjective | 37 | 2021-08-29actual | — | 2021-12-23 |
| A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque PsoriasisNCT04673786results2023-06-05The Mean Percent Improvement From Baseline in PASI Score at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P43, Stelara | Psoriasis | 509 | 2021-08-04actual | — | 2023-06-05 |
| A Phase 2/3 Study to Evaluate the Efficacy and Safety of CT-P59 in Patients With Mild to Moderate SARS-CoV-2 InfectionNCT04602000results2022-07-20Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan: Part 1 ↗ · Statistical Analysis Plan: Part 2 ↗ | Phase 2/3 | Completed | Biological: CT-P59, CT-P59, Placebo, CT-P59, Placebo | SARS-CoV-2 Infection | 1,642 | 2021-05-21actual | — | 2022-07-20 |
| A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male SubjectsNCT04512872Evaluate safetyRandomized · Quadruple-masked · Other | Phase 1 | Completed | Biological: CT-P41, EU-approved Prolia | Healthy Male Subjects | 30 | 2021-05-04actual | — | 2021-09-01 |
| 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 CancerNCT03676192results2025-03-17Objective Response Rate (ORR) During the Induction Study Period From Central ReviewRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: CT-P16, Avastin | Adenocarcinoma of Lung | 689 | 2021-04-22actual | — | 2025-03-17 |
| To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy SubjectsNCT04018313results2023-05-11Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2Randomized · Quadruple-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: CT-P39, EU-approved Xolair, CT-P39, EU-approved Xolair, US-licensed Xolair | Healthy | 176 | 2021-03-27actual | — | 2023-05-11 |
| An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing SpondylitisNCT02557308results2024-12-09observationalThe Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)Study Protocol ↗ · Statistical Analysis Plan ↗ | — | Terminatedsponsor's stated reason: Terminated | — | Ankylosing Spondylitis | 329 | 2021-02-28actual | — | 2024-12-09 |
| Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy SubjectsNCT04428814Demonstrate PK similarityRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Biological: CT-P43, EU-approved Stelara, US-licensed Stelara | Healthy Subjects | 271 | 2021-02-24actual | — | 2021-08-05 |
| 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)NCT04593641results2022-04-08Number of Patients With TEAEsRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: CT-P59 | SARS-CoV-2 Infection | 18 | 2020-10-26actual | — | 2022-04-08 |
| To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy SubjectsNCT04525079results2021-11-16Preliminary Safety and Tolerability of CT-P59Randomized · Quadruple-masked · ScreeningStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: CT-P59, Placebo | SARS-CoV-2 Infection | 32 | 2020-08-07actual | — | 2021-11-16 |
| Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human ParticipantsNCT03918967Incidence of Adverse events including serious Adverse events (Part I, Part II)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: CT-G11, CT-G20, CT-G11 Placebo, CT-G20 Placebo | Healthy | 72 | 2020-06-06actual | — | 2020-06-09 |
| To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid ArthritisNCT03707535Efficacy assessment: DAS28 (CRP) at Week 14Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Biological: CT-P13, Remicade | Rheumatoid Arthritis | 270 | 2020-03-16actual | — | 2021-09-14 |
| An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RANCT02557295results2024-02-05observationalThe Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)Study Protocol ↗ · Statistical Analysis Plan ↗ | — | Terminatedsponsor's stated reason: Terminated | — | Rheumatoid Arthritis | 248 | 2020-03-02actual | — | 2024-11-26 |
| To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)NCT02326155results2022-02-21observationalNumber and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI)Study Protocol ↗ · Statistical Analysis Plan ↗ | — | Terminatedsponsor's stated reason: Terminated | — | Crohn's Disease, Ulcerative Colitis | 470 | 2020-02-28actual | — | 2022-02-21 |
| To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17NCT04295356results2020-12-07Peak Plasma Concentration (Cmax)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: CT-P17, CT-P17 | Healthy | 180 | 2019-11-15actual | — | 2021-01-19 |
| To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy SubjectsNCT03970824results2020-12-11Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)Randomized · Quadruple-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: CT-P17, US-licensed Humira, EU-approved Humira | Healthy | 312 | 2019-11-13actual | — | 2021-11-18 |
| A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid ArthritisNCT04171414results2021-11-17The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P17 SC AI (adalimumab) | Rheumatoid Arthritis | 62 | 2019-11-04actual | — | 2021-11-17 |
| A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid ArthritisNCT03789292results2021-11-17American College of Rheumatology(ACR)20 Response Rate at Week 24.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P17 SC, Humira SC | Rheumatoid Arthritis | 648 | 2019-10-08actual | — | 2021-11-17 |
| A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative ColitisNCT02883452results2020-06-09Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan: Statistical Analysis Plan (Part 1) ↗ · Statistical Analysis Plan: Statistical Analysis Plan (Part 2) ↗ | Phase 1 | Completed | Biological: CT-P13, CT-P13, CT-P13, CT-P13, CT-P13, CT-P13 | Crohn's Disease, Ulcerative Colitis (Part 2 Only) | 181 | 2019-02-04actual | — | 2020-06-09 |
| CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy SubjectsNCT03446976To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects.Randomized · Open-label · Other | Phase 1 | Completed | Biological: CT-P13 SC Auto-injector, CT-P13 SC Pre-filled Syringe | Health, Subjective | 218 | 2018-07-26actual | — | 2019-07-26 |
| A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RANCT03147248results2020-04-08Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan: Statistical Analysis Plan (Part 2) ↗ · Statistical Analysis Plan: Statistical Analysis Plan Addendum (Part 2) ↗ · Statistical Analysis Plan: Statistical Analysis Plan (Part 1) ↗ | Phase 3 | Completed | Biological: CT-P13, CT-P13, CT-P13, CT-P13, CT-P13, CT-P13 | Rheumatoid Arthritis | 407 | 2018-05-21actual | — | 2020-04-08 |
| A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A InfectionNCT03511066results2022-10-31Time to Resolution of Influenza Symptoms and FeverRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: CT-P27 2.2 is inactivated | Drug: CT-P27 90 mg/kg, CT-P27 45 mg/kg, Placebo | Influenza A | 228 | 2018-03-09actual | — | 2022-10-31 |
| To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular LymphomaNCT02260804results2021-04-08Primary Efficacy Endpoint - Overall Response Rate by 7 MonthsRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P10, Rituxan | Follicular Lymphoma | 258 | 2018-01-04actual | — | 2021-04-08 |
| To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed AvastinNCT03247673results2019-07-25AUC0-infRandomized · Quadruple-masked · Basic scienceStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 1 | Completed | Drug: CT-P16, EU-approved Avastin, US-licensed Avastin | Healthy | 141 | 2017-12-22actual | — | 2020-03-26 |
| Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast CancerNCT02162667results2019-10-29The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Trastuzumab | HER2-positive Carcinoma of Breast | 562 | 2016-05-26actual | — | 2022-08-03 |
| Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed HerceptinNCT02665637Pharmacokinetics will be assessed by AUCRandomized · Double-masked | Phase 1 | Completed | Drug: Trastuzumab | Healthy Volunteers | 70 | Apr 2016actual | — | 2016-08-26 |
| PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid ArthritisNCT02149121results2021-12-16Analysis of Serum AUC0-last of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: CT-P10 · Drug: Rituxan, MabThera | Rheumatoid Arthritis | 384 | Jan 2016actual | — | 2021-12-16 |
| To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With RituxanNCT02162771results2020-01-29Area Under the Serum Concentration-time Curve at Steady State (AUCtau)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Biological: Rituxan, CT-P10 · Drug: Cyclophosphamide, Vincristine, Prednisone | Lymphoma, Follicular | 140 | 2016-01-12actual | — | 2020-01-29 |
| Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's DiseaseNCT02096861results2018-04-11The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6Randomized · Double-masked · Treatment | Phase 3 | Completed | Biological: CT-P13, Remicade | Crohn's Disease | 220 | 2016-01-11actual | — | 2018-05-09 |
| Long-Term Efficacy and Safety of CT-P10 in Patients With RANCT01873443Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoringOpen-label · Treatment | Phase 1 | Completed | Drug: Rituximab, MTX, folic acid | Rheumatoid Arthritis | 87 | Oct 2014actual | — | 2015-11-26 |
| A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge ModelNCT02071914results2020-03-16Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCRRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: CT-P27, Placebo | Influenza A | 81 | 2014-05-19actual | — | 2020-04-08 |
| Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid ArthritisNCT01534884PK in terms of CmaxRandomized · Double-masked · Treatment | Phase 1 | Completed | Biological: rituximab | Rheumatoid Arthritis | 154 | Aug 2013actual | — | 2015-05-22 |
| 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 3.1NCT01571219Long term efficacy evaluated by American College of Rheumatology(ACR) criteria and Long term safety evaluated by immunogenicity and clinical laboratory testOpen-label · Treatment | Phase 3 | Completed | Biological: Infliximab | Rheumatoid Arthritis | 302 | Jul 2013actual | — | 2017-08-01 |
| 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 1.1NCT01571206Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) criteria and Long term safety evaluated by immunogenicity and clinical laboratory testOpen-label · Treatment | Phase 1 | Completed | Biological: Infliximab | Ankylosing Spondylitis | 174 | May 2013actual | — | 2013-07-31 |
| Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence TrialNCT01534949safetyOpen-label · Treatment | Phase 1 | Terminated | Biological: rituximab | Diffuse Large B-Cell Lymphoma | 1 | Feb 2013actual | — | 2014-07-23 |
| Demonstrate Efficacy and Safety of Metastatic Breast CancerNCT01084876results2025-02-11Objective Response RateRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: CT-P6, Herceptin, Paclitaxel | Metastatic Breast Cancer | 475 | Jul 2012actual | — | 2025-02-11 |
| Evaluate Safety, Efficacy and PharmacokineticsNCT01084863results2025-01-24Area Under the Concentration Time Curve at Steady State (AUCss)Randomized · Triple-masked · Treatment | Phase 1/2 | Completed | Drug: CT-P6, Herceptin, Paclitaxel | Metastatic Breast Cancer | 143 | Dec 2011actual | — | 2025-01-24 |
| Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)NCT01217086PK equivalence to remicadeRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Infliximab | Rheumatoid Arthritis | 617 | Nov 2011actual | — | 2013-03-12 |
| Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)NCT01220518PK equivalence to remicadeRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Infliximab | Ankylosing Spondylitis | 257 | Nov 2011actual | — | 2013-03-12 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19