11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | EUCTR2016-002698-36-ES (EUCTR) | 25/05/2017 | 31/03/2017 | 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: 19.1;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: UCB7665 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 | ||
| 24 | 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 | ||
| 25 | NCT03052751 (ClinicalTrials.gov) | May 15, 2017 | 10/2/2017 | 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 | Myasthenia Gravis | Drug: UCB7665;Other: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 43 | Phase 2 | United States;Belgium;Canada;Czechia;Denmark;Germany;Spain |
| 26 | 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 | ||
| 27 | 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 |