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

  
35 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05681715
(ClinicalTrials.gov)
March 9, 20234/1/2023A 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 GravisGeneralized Myasthenia GravisDrug: RozanolixizumabUCB Biopharma SRLNULLNot yet recruiting18 YearsN/AAll30Phase 3NULL
2JPRN-jRCT2021200038
09/02/202109/02/2021A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis - MG0007 Generalized Myasthenia GravisRozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.SUGIHARA KazuhiroNULLRecruiting>= 18age oldNot applicableBoth18Phase 3Belgium;Canada;Czech Republic,;Denmark;France;Georgia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Taiwan;UK;US;Japan
3NCT04650854
(ClinicalTrials.gov)
February 3, 20215/11/2020A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia GravisAn Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: RozanolixizumabUCB Biopharma SRLNULLActive, not recruiting18 YearsN/AAll165Phase 3United States;Canada;Czechia;Denmark;France;Georgia;Germany;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Taiwan;Hungary
4EUCTR2020-003230-20-BE
(EUCTR)
11/01/202107/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn 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 SRLNULLNot RecruitingFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
5EUCTR2020-003230-20-IT
(EUCTR)
15/12/202030/08/2021A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
6EUCTR2020-003230-20-PL
(EUCTR)
14/12/202030/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
7EUCTR2020-003230-20-DE
(EUCTR)
02/12/202014/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
8EUCTR2020-003230-20-HU
(EUCTR)
01/12/202001/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn 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 SRLNULLNot RecruitingFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
9EUCTR2020-003230-20-GB
(EUCTR)
30/11/202002/09/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;China;Japan
10EUCTR2020-003230-20-DK
(EUCTR)
17/11/202006/10/2020A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravisAn 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;China;Japan
11JPRN-JapicCTI-205350
20/7/202001/07/2020A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 gravisIntervention 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.NULLcomplete18BOTH18Phase 3Japan, Asia except Japan, North America, Europe
12EUCTR2019-000969-21-DE
(EUCTR)
20/04/202005/11/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
13EUCTR2019-000969-21-PL
(EUCTR)
12/04/202020/02/2020A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany
14JPRN-JapicCTI-205207
11/3/202004/03/2020A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Generalized myasthenia gravisIntervention 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.NULLcomplete18BOTH18Phase 3Japan, Asia except Japan, North America, Europe
15EUCTR2019-000969-21-CZ
(EUCTR)
24/02/202020/12/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
16EUCTR2019-000969-21-ES
(EUCTR)
14/02/202011/11/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
17EUCTR2019-000969-21-IT
(EUCTR)
15/01/202027/01/2021A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 3United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
18EUCTR2019-000969-21-GB
(EUCTR)
06/01/202015/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
19EUCTR2019-000968-18-PL
(EUCTR)
19/12/201909/07/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany
20EUCTR2019-000969-21-HU
(EUCTR)
04/12/201915/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany
21EUCTR2019-000968-18-DE
(EUCTR)
15/11/201910/07/2019A 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 SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
22EUCTR2019-000968-18-GB
(EUCTR)
14/11/201928/06/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Russian Federation;Hong Kong;Hungary;United States;United Kingdom;Spain;Canada;Czech Republic;Belgium;Taiwan;Denmark;Poland;Italy;France;Germany
23EUCTR2019-000968-18-CZ
(EUCTR)
11/11/201913/08/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
24EUCTR2019-000969-21-DK
(EUCTR)
07/11/201917/10/2019A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLNot RecruitingFemale: yes
Male: yes
276Phase 3United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
25NCT04124965
(ClinicalTrials.gov)
October 29, 201911/10/2019A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisA Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: RozanolixizumabUCB Biopharma SRLNULLCompleted18 YearsN/AAll71Phase 3United States;Canada;Czechia;Denmark;France;Germany;Italy;Japan;Poland;Russian Federation;Spain;Taiwan
26EUCTR2019-000968-18-BE
(EUCTR)
14/10/201914/08/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
27EUCTR2019-000968-18-IT
(EUCTR)
25/09/201927/01/2021A 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 SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
28EUCTR2019-000968-18-HU
(EUCTR)
25/09/201923/07/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany
29EUCTR2019-000968-18-DK
(EUCTR)
06/09/201924/06/2019A 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 SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
30EUCTR2019-000968-18-ES
(EUCTR)
28/08/201912/09/2019A 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 SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
31NCT03971422
(ClinicalTrials.gov)
June 3, 201929/5/2019A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: Rozanolixizumab;Other: PlaceboUCB Biopharma SRLNULLCompleted18 YearsN/AAll200Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Taiwan;United Kingdom
32EUCTR2016-002698-36-CZ
(EUCTR)
26/05/201703/04/2017Study 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
33EUCTR2016-002698-36-DK
(EUCTR)
19/05/201707/04/2017 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 SPRLNULLNot 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): noUnited States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
34EUCTR2016-002698-36-DE
(EUCTR)
09/02/201728/11/2016Study 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
35EUCTR2016-002698-36-BE
(EUCTR)
30/01/201729/11/2016Study 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 SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany