Tralokinumab (DrugBank: Tralokinumab)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 85 | 特発性間質性肺炎 | 3 |
| 97 | 潰瘍性大腸炎 | 6 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02036580 (ClinicalTrials.gov) | January 2014 | 13/1/2014 | D2212C00002 J-Phase II Study | A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: tralokinumab cohort 1;Biological: tralokinumab cohort 2;Other: Placebo | AstraZeneca | MedImmune LLC | Completed | 50 Years | N/A | All | 37 | Phase 2 | Japan |
| 2 | NCT01629667 (ClinicalTrials.gov) | October 2012 | 12/6/2012 | A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis | A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: Tralokinumab;Other: Placebo | MedImmune LLC | NULL | Terminated | 50 Years | 79 Years | All | 409 | Phase 2 | United States;Australia;Canada;Israel;Korea, Republic of;Peru |
| 3 | JPRN-JapicCTI-142452 | 21/02/2014 | A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis | A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Intervention name : Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor Dosage And administration of the intervention : Low Dose, Biological: tralokinumab cohort 1, High Dose, Biological: tralokinumab cohort 2 | AstraZeneca | MedImmune LLC | 50 | BOTH | Phase 2 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-004812-40-GB (EUCTR) | 12/04/2012 | 21/03/2012 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | Czech Republic;Netherlands;Germany;Italy;United Kingdom | ||
| 2 | NCT01482884 (ClinicalTrials.gov) | March 2012 | 29/11/2011 | Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis | A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis | Ulcerative Colitis | Drug: tralokinumab;Drug: placebo | AstraZeneca | MedImmune Ltd | Completed | 18 Years | 65 Years | All | 147 | Phase 2 | Czech Republic;France;Germany;Italy;Poland;United Kingdom;Netherlands |
| 3 | EUCTR2011-004812-40-DE (EUCTR) | 26/01/2012 | 25/11/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2a | Czech Republic;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2011-004812-40-NL (EUCTR) | 25/01/2012 | 22/12/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2a | Czech Republic;Netherlands;United Kingdom;Italy | ||
| 5 | EUCTR2011-004812-40-CZ (EUCTR) | 24/01/2012 | 29/12/2011 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2a | Czech Republic;Netherlands;United Kingdom;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2011-004812-40-IT (EUCTR) | 12/12/2011 | 02/03/2012 | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 INN or Proposed INN: tralokinumab Other descriptive name: NA | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2a | Czech Republic;Netherlands;Germany;United Kingdom;Italy |