Zilucoplan    (DrugBank: Zilucoplan)

3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2
11重症筋無力症7
62発作性夜間ヘモグロビン尿症4

2. 筋萎縮性側索硬化症 [臨床試験数:508,薬物数:530(DrugBank:146),標的遺伝子数:170,標的パスウェイ数:221
Searched query = "Amyotrophic lateral sclerosis", "ALS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 508 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04436497
(ClinicalTrials.gov)
July 29, 20201/6/2020HEALEY ALS Platform Trial - Regimen A ZilucoplanHEALEY ALS Platform Trial - Regimen A ZilucoplanAmyotrophic Lateral SclerosisDrug: Zilucoplan;Drug: Matching PlaceboMerit E. Cudkowicz, MDRa PharmaceuticalsEnrolling by invitation18 YearsN/AAll160Phase 2;Phase 3United States
2NCT04297683
(ClinicalTrials.gov)
July 14, 20203/3/2020HEALEY ALS Platform Trial - Master ProtocolHEALEY ALS Platform TrialAmyotrophic Lateral SclerosisDrug: Zilucoplan;Drug: Verdiperstat;Drug: CNM-Au8Merit E. Cudkowicz, MDMassachusetts General HospitalRecruiting18 YearsN/AAll480Phase 2;Phase 3United States

11. 重症筋無力症 [臨床試験数:226,薬物数:172(DrugBank:45),標的遺伝子数:43,標的パスウェイ数:118
Searched query = "Myasthenia", "MG"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 226 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001565-33-ES
(EUCTR)
13/05/202014/01/2020Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;France;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy
2EUCTR2019-001564-30-ES
(EUCTR)
13/05/202011/11/2019A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United Kingdom;Japan;Italy;United States;France;Canada;Spain;Norway;Germany
3NCT04225871
(ClinicalTrials.gov)
December 23, 20192/10/2019Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: zilucoplan (RA101495)Ra PharmaceuticalsNULLRecruiting18 YearsN/AAll200Phase 3United States;Canada;France;Germany;Italy;Japan;Norway;Spain;United Kingdom
4EUCTR2019-001565-33-GB
(EUCTR)
30/10/201901/11/2019Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia GravisA Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom
5EUCTR2019-001564-30-GB
(EUCTR)
29/10/201901/11/2019A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04115293
(ClinicalTrials.gov)
October 1, 20192/10/2019Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: zilucoplan (RA101495);Drug: PlaceboRa PharmaceuticalsNULLRecruiting18 Years75 YearsAll130Phase 3United States;Canada;France;Germany;Italy;Japan;Norway;Spain;United Kingdom
7NCT03315130
(ClinicalTrials.gov)
October 11, 201716/10/2017Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia GravisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: zilucoplan (RA101495);Drug: PlaceboRa PharmaceuticalsNULLActive, not recruiting18 Years85 YearsAll44Phase 2United States;Canada

62. 発作性夜間ヘモグロビン尿症 [臨床試験数:202,薬物数:120(DrugBank:25),標的遺伝子数:15,標的パスウェイ数:90
Searched query = "Paroxysmal nocturnal hemoglobinuria", "PNH"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
4 / 202 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003956-19-FI
(EUCTR)
13/02/201928/01/2019Study of Zilucoplan in Treatment-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)Phase 3, Multicenter, Open-Label, Single-Arm Study to Confirm the Safety and Efficacy of Zilucoplan in Treatment-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria - Phase 3 Study in Treatment-Naive Paroxysmal Nocturnal Hemoglobinuria Patients Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Zilucoplan
Product Code: RA101495
INN or Proposed INN: ZILUCOPLAN
Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker
Ra Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Hong Kong;Taiwan;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Georgia;Germany;New Zealand;Korea, Republic of
2NCT03225287
(ClinicalTrials.gov)
July 17, 201717/7/2017Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical StudyA Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical StudyParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: Zilucoplan (RA101495)Ra PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll28Phase 2United States;Australia;Denmark;Finland;Germany;Hungary;New Zealand;United Kingdom
3NCT03030183
(ClinicalTrials.gov)
April 17, 201720/1/2017Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to EculizumabA Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have an Inadequate Response to EculizumabParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: Zilucoplan (RA101495)Ra PharmaceuticalsNULLCompleted18 YearsN/AAll3Phase 2United States
4NCT03078582
(ClinicalTrials.gov)
March 8, 20178/3/2017Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH PatientsPhase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: Zilucoplan (RA101495)Ra PharmaceuticalsNULLCompleted18 YearsN/AAll26Phase 2Australia;Canada;Denmark;Finland;Germany;Hungary;New Zealand;United Kingdom