ROZANOLIXIZUMAB ( DrugBank: Rozanolixizumab )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 11 | 重症筋無力症 | 35 |
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 17 |
| 63 | 特発性血小板減少性紫斑病 | 33 |
11. 重症筋無力症
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| 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 | NCT05681715 (ClinicalTrials.gov) | March 9, 2023 | 4/1/2023 | A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG) | An Open-label, Crossover Study to Evaluate Rozanolixizumab Self-administration by Study Participants With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Not yet recruiting | 18 Years | N/A | All | 30 | Phase 3 | NULL |
| 2 | JPRN-jRCT2021200038 | 09/02/2021 | 09/02/2021 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis - MG0007 | Generalized Myasthenia Gravis | Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2. | SUGIHARA Kazuhiro | NULL | Recruiting | >= 18age old | Not applicable | Both | 18 | Phase 3 | Belgium;Canada;Czech Republic,;Denmark;France;Georgia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Taiwan;UK;US;Japan |
| 3 | NCT04650854 (ClinicalTrials.gov) | February 3, 2021 | 5/11/2020 | A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | N/A | All | 165 | Phase 3 | United States;Canada;Czechia;Denmark;France;Georgia;Germany;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Taiwan;Hungary |
| 4 | EUCTR2020-003230-20-BE (EUCTR) | 11/01/2021 | 07/10/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan | ||
| 5 | EUCTR2020-003230-20-IT (EUCTR) | 15/12/2020 | 30/08/2021 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis - - | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: [UCB7665] INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan | ||
| 6 | EUCTR2020-003230-20-PL (EUCTR) | 14/12/2020 | 30/09/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan | ||
| 7 | EUCTR2020-003230-20-DE (EUCTR) | 02/12/2020 | 14/09/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan | ||
| 8 | EUCTR2020-003230-20-HU (EUCTR) | 01/12/2020 | 01/10/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan | ||
| 9 | EUCTR2020-003230-20-GB (EUCTR) | 30/11/2020 | 02/09/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan | ||
| 10 | EUCTR2020-003230-20-DK (EUCTR) | 17/11/2020 | 06/10/2020 | A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis | An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan | ||
| 11 | JPRN-JapicCTI-205350 | 20/7/2020 | 01/07/2020 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized myasthenia gravis | Intervention name : Rozanolixizumab INN of the intervention : rozanolixizumab Dosage And administration of the intervention : Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages (dose 1 and dose 2) in dosage regimen 1 and 2. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | complete | 18 | BOTH | 18 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 12 | EUCTR2019-000969-21-DE (EUCTR) | 20/04/2020 | 05/11/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 13 | EUCTR2019-000969-21-PL (EUCTR) | 12/04/2020 | 20/02/2020 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany | ||
| 14 | JPRN-JapicCTI-205207 | 11/3/2020 | 04/03/2020 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized myasthenia gravis | Intervention name : Rozanolixizumab INN of the intervention : rozanolixizumab Dosage And administration of the intervention : Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages (dose 1 and dose 2) in dosage regimen 1 and 2. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | complete | 18 | BOTH | 18 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 15 | EUCTR2019-000969-21-CZ (EUCTR) | 24/02/2020 | 20/12/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 16 | EUCTR2019-000969-21-ES (EUCTR) | 14/02/2020 | 11/11/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 17 | EUCTR2019-000969-21-IT (EUCTR) | 15/01/2020 | 27/01/2021 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients WithGeneralized Myasthenia Gravis - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: [UCB7665] INN or Proposed INN: rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 3 | United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 18 | EUCTR2019-000969-21-GB (EUCTR) | 06/01/2020 | 15/10/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 276 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 19 | EUCTR2019-000968-18-PL (EUCTR) | 19/12/2019 | 09/07/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany | ||
| 20 | EUCTR2019-000969-21-HU (EUCTR) | 04/12/2019 | 15/10/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany | ||
| 21 | EUCTR2019-000968-18-DE (EUCTR) | 15/11/2019 | 10/07/2019 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 22 | EUCTR2019-000968-18-GB (EUCTR) | 14/11/2019 | 28/06/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Russian Federation;Hong Kong;Hungary;United States;United Kingdom;Spain;Canada;Czech Republic;Belgium;Taiwan;Denmark;Poland;Italy;France;Germany | ||
| 23 | EUCTR2019-000968-18-CZ (EUCTR) | 11/11/2019 | 13/08/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 24 | EUCTR2019-000969-21-DK (EUCTR) | 07/11/2019 | 17/10/2019 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 3 | United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 25 | NCT04124965 (ClinicalTrials.gov) | October 29, 2019 | 11/10/2019 | A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Completed | 18 Years | N/A | All | 71 | Phase 3 | United States;Canada;Czechia;Denmark;France;Germany;Italy;Japan;Poland;Russian Federation;Spain;Taiwan |
| 26 | EUCTR2019-000968-18-BE (EUCTR) | 14/10/2019 | 14/08/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 27 | EUCTR2019-000968-18-HU (EUCTR) | 25/09/2019 | 23/07/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis | A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany | ||
| 28 | EUCTR2019-000968-18-IT (EUCTR) | 25/09/2019 | 27/01/2021 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: [UCB7665] INN or Proposed INN: rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 29 | EUCTR2019-000968-18-DK (EUCTR) | 06/09/2019 | 24/06/2019 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 30 | EUCTR2019-000968-18-ES (EUCTR) | 28/08/2019 | 12/09/2019 | A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. | A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy | Generalized myasthenia gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany | ||
| 31 | NCT03971422 (ClinicalTrials.gov) | June 3, 2019 | 29/5/2019 | A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma SRL | NULL | Completed | 18 Years | N/A | All | 200 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Taiwan;United Kingdom |
| 32 | EUCTR2016-002698-36-CZ (EUCTR) | 26/05/2017 | 03/04/2017 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 33 | EUCTR2016-002698-36-DK (EUCTR) | 19/05/2017 | 07/04/2017 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 34 | EUCTR2016-002698-36-DE (EUCTR) | 09/02/2017 | 28/11/2016 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany | ||
| 35 | EUCTR2016-002698-36-BE (EUCTR) | 30/01/2017 | 29/11/2016 | Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis. | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. | Moderate to severe myasthenia gravis MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: rozanolixizumab Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany |
14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| 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 | NCT05014724 (ClinicalTrials.gov) | November 12, 2021 | 19/8/2021 | CIDP07 Rozanolixizumab Post Trial Access Program (the PTA) | CIDP07 Rozanolixizumab Post Trial Access Program (the PTA) | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Available | 18 Years | N/A | All | NULL | ||
| 2 | EUCTR2018-004392-12-NL (EUCTR) | 11/06/2020 | 09/09/2019 | A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB Other descriptive name: Rozanolixizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 3 | EUCTR2018-004392-12-DE (EUCTR) | 29/04/2020 | 10/04/2019 | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB Other descriptive name: Rozanolixizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2018-004392-12-GB (EUCTR) | 20/11/2019 | 01/04/2019 | A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB Other descriptive name: Rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Phase 2 | Canada;Netherlands;Belgium;United States;Denmark;United Kingdom;Italy;France;Germany;Spain | ||
| 5 | EUCTR2018-004392-12-DK (EUCTR) | 29/10/2019 | 16/09/2019 | A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB Other descriptive name: Rozanolixizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2018-004392-12-FR (EUCTR) | 10/09/2019 | 13/05/2019 | A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB Other descriptive name: Rozanolixizumab | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom | ||
| 7 | NCT04051944 (ClinicalTrials.gov) | August 21, 2019 | 8/8/2019 | A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Completed | 18 Years | N/A | All | 21 | Phase 2 | United States;Belgium;Denmark;France;Germany;Netherlands;Spain;United Kingdom |
| 8 | EUCTR2018-004392-12-BE (EUCTR) | 20/08/2019 | 23/05/2019 | A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB Other descriptive name: Rozanolixizumab | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom | ||
| 9 | EUCTR2018-004392-12-ES (EUCTR) | 01/08/2019 | 11/06/2019 | A study to assess long-term safety, tolerability and efficacy of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB Other descriptive name: Rozanolixizumab | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom | ||
| 10 | EUCTR2016-002411-17-GB (EUCTR) | 23/07/2019 | 14/08/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 11 | EUCTR2016-002411-17-FR (EUCTR) | 02/07/2019 | 19/07/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom | ||
| 12 | EUCTR2016-002411-17-NL (EUCTR) | 13/06/2019 | 02/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 13 | EUCTR2016-002411-17-DE (EUCTR) | 23/05/2019 | 04/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 14 | EUCTR2016-002411-17-ES (EUCTR) | 09/05/2019 | 11/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom | ||
| 15 | EUCTR2016-002411-17-BE (EUCTR) | 29/04/2019 | 08/02/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 16 | EUCTR2016-002411-17-DK (EUCTR) | 11/04/2019 | 20/02/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 17 | NCT03861481 (ClinicalTrials.gov) | March 26, 2019 | 1/3/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 34 | Phase 2 | United States;Belgium;Denmark;France;Germany;Netherlands;Spain;United Kingdom;Canada |
63. 特発性血小板減少性紫斑病
臨床試験数 : 391 / 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
| 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 | EUCTR2019-000884-26-HR (EUCTR) | 09/09/2021 | 24/11/2021 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Netherlands;Japan;Moldova, Republic of;Korea, Republic of | ||
| 2 | JPRN-jRCT2031210245 | 31/08/2021 | 16/08/2021 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - TP0004 | Primary immune thrombocytopenia | Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Periods. Study participants will receive fixed-unit doses of rozanolixizumab across body weight tiers. | Sugihara Kazuhiro | NULL | Recruiting | >= 18age old | Not applicable | Both | 10 | Phase 3 | Austria;Belgium;Bulgaria;Canada;China;Czechia;France;Georgia;Germany;Hong Kong;Hungary;Italy;Republic of Moldova;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;United States;Japan |
| 3 | EUCTR2019-003451-11-DK (EUCTR) | 17/06/2021 | 19/04/2021 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Serbia;United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;China | ||
| 4 | EUCTR2019-000884-26-GR (EUCTR) | 25/05/2021 | 01/04/2021 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of | ||
| 5 | EUCTR2019-000883-40-DE (EUCTR) | 09/04/2021 | 10/09/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Denmark;Netherlands;China;Moldova, Republic of;United States;Serbia;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 6 | NCT04596995 (ClinicalTrials.gov) | December 30, 2020 | 15/10/2020 | A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Completed | 18 Years | N/A | All | 43 | Phase 3 | United States;China;Georgia;Germany;Hungary;Italy;Japan;Moldova, Republic of;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom |
| 7 | EUCTR2019-000883-40-BG (EUCTR) | 25/11/2020 | 24/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Serbia;United States;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 8 | EUCTR2019-000883-40-GB (EUCTR) | 29/10/2020 | 11/09/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 9 | EUCTR2019-000883-40-PL (EUCTR) | 09/10/2020 | 25/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 10 | EUCTR2019-000883-40-CZ (EUCTR) | 05/10/2020 | 12/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 11 | EUCTR2019-000883-40-HU (EUCTR) | 29/09/2020 | 11/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 12 | EUCTR2019-003451-11-FR (EUCTR) | 08/09/2020 | 13/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan | ||
| 13 | EUCTR2019-003451-11-DE (EUCTR) | 17/08/2020 | 14/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 14 | JPRN-JapicCTI-205351 | 13/7/2020 | 01/07/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Primary immune thrombocytopenia | Intervention name : Rozanolixizumab INN of the intervention : rozanolixizumab Dosage And administration of the intervention : Study participants receive rozanolixizumab by subcutaneous infusion at pre-specified time points. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | recruiting | 18 | BOTH | 10 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 15 | EUCTR2019-003451-11-AT (EUCTR) | 13/07/2020 | 28/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Serbia;United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;China | ||
| 16 | EUCTR2019-000884-26-AT (EUCTR) | 06/07/2020 | 28/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of;United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation | ||
| 17 | EUCTR2019-000884-26-IT (EUCTR) | 09/06/2020 | 17/06/2021 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants with Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: [UCB7665] INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Netherlands;Moldova, Republic of;China;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 18 | NCT04224688 (ClinicalTrials.gov) | June 3, 2020 | 8/1/2020 | A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma SRL | NULL | Terminated | 18 Years | N/A | All | 30 | Phase 3 | United States;Bulgaria;China;France;Germany;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;Austria;Belgium;Canada;Czechia;Denmark;Hong Kong;Italy;Romania;Serbia;Turkey |
| 19 | EUCTR2019-003451-11-CZ (EUCTR) | 28/05/2020 | 26/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 20 | EUCTR2019-000884-26-NL (EUCTR) | 22/05/2020 | 03/03/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 21 | EUCTR2019-003451-11-NL (EUCTR) | 22/05/2020 | 03/03/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan;United States;Taiwan | ||
| 22 | EUCTR2019-000884-26-FR (EUCTR) | 11/05/2020 | 26/05/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 23 | EUCTR2019-003451-11-IT (EUCTR) | 04/05/2020 | 27/01/2021 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: [UCB7665] INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan | ||
| 24 | EUCTR2019-000884-26-BG (EUCTR) | 30/04/2020 | 04/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of | ||
| 25 | EUCTR2019-003451-11-BG (EUCTR) | 30/04/2020 | 04/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Czechia;Taiwan;Hong Kong;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;China | ||
| 26 | EUCTR2019-000884-26-CZ (EUCTR) | 23/04/2020 | 25/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Moldova, Republic of;Japan;Korea, Republic of | ||
| 27 | EUCTR2019-000884-26-ES (EUCTR) | 22/04/2020 | 28/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Netherlands;China;Moldova, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 28 | EUCTR2019-003451-11-ES (EUCTR) | 22/04/2020 | 28/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;China;Japan | ||
| 29 | EUCTR2019-000884-26-GB (EUCTR) | 20/04/2020 | 16/03/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan | ||
| 30 | EUCTR2019-000884-26-HU (EUCTR) | 13/04/2020 | 11/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of | ||
| 31 | EUCTR2019-003451-11-PL (EUCTR) | 25/03/2020 | 11/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Czechia;Taiwan;Hong Kong;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Germany;Netherlands;China | ||
| 32 | EUCTR2019-000884-26-PL (EUCTR) | 20/03/2020 | 03/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Netherlands;Moldova, Republic of;Japan;United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Korea, Republic of | ||
| 33 | NCT04200456 (ClinicalTrials.gov) | January 31, 2020 | 13/12/2019 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma SRL | NULL | Terminated | 18 Years | N/A | All | 33 | Phase 3 | United States;Bulgaria;France;Georgia;Greece;Hungary;Italy;Japan;Korea, Republic of;Moldova, Republic of;Poland;Romania;Russian Federation;Taiwan;Ukraine;United Kingdom;Austria;Belgium;Croatia;Czechia;Spain |