Biib059 (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 49 | 全身性エリテマトーデス | 4 |
| 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 | EUCTR2015-004359-32-PL (EUCTR) | 10/06/2017 | 24/04/2017 | Study to Evaluate BIIB059 in CLE with or without SLE | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. | Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIIB059 Product Code: BIIB059 INN or Proposed INN: Not Available Other descriptive name: anti-blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of | ||
| 2 | EUCTR2015-004359-32-BG (EUCTR) | 01/02/2017 | 03/11/2016 | Study to Evaluate BIIB059 in CLE with or without SLE | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. | Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BIIB059 Product Code: BIIB059 INN or Proposed INN: Not Available Other descriptive name: anti-blood dendritic cell antigen 2 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of | ||
| 3 | NCT02847598 (ClinicalTrials.gov) | October 20, 2016 | 6/6/2016 | Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations | Systemic Lupus Erythematosus;Active Cutaneous Lupus Erythematosus | Drug: BIIB059;Drug: Placebo | Biogen | NULL | Completed | 18 Years | 75 Years | All | 264 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Israel;Korea, Republic of;Mexico;Philippines;Poland;Serbia;Taiwan;Thailand |
| 4 | NCT02106897 (ClinicalTrials.gov) | April 30, 2014 | 4/4/2014 | Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus Erythematosus | A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Healthy Volunteers | Drug: BIIB059;Drug: Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 109 | Phase 1 | United States |