Dapirolizumab pegol (dzp) (DrugBank: Dapirolizumab pegol)
1 disease告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
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49 | 全身性エリテマトーデス | 3 |
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 |
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1 | EUCTR2015-004457-40-PL (EUCTR) | 04/11/2016 | 02/09/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTSWITH MODERATELY TO SEVERELY ACTIVE SYSTEMICLUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
2 | EUCTR2015-004457-40-ES (EUCTR) | 10/10/2016 | 05/08/2016 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | ||
3 | NCT02804763 (ClinicalTrials.gov) | June 2, 2016 | 14/6/2016 | A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Placebo;Drug: Dapirolizumab pegol (DZP) | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 182 | Phase 2 | United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine |