PEGCETACOPLAN ( DrugBank: Pegcetacoplan )


4 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6
61自己免疫性溶血性貧血2
62発作性夜間ヘモグロビン尿症14
222一次性ネフローゼ症候群15

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003797-10-NL
(EUCTR)
23/07/202109/11/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Netherlands;Germany;Japan
2EUCTR2019-003797-10-CZ
(EUCTR)
13/05/202127/10/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan
3EUCTR2019-003797-10-IE
(EUCTR)
06/04/202103/09/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Aspaveli
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Australia;Netherlands;Germany;Japan
4EUCTR2019-003797-10-DE
(EUCTR)
18/02/202112/10/2020A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Aspaveli
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: PEGCETACOPLAN
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Poland;Belgium;Australia;Germany;Netherlands;Japan
5EUCTR2019-003797-10-IT
(EUCTR)
03/02/202128/07/2021A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALSA Phase 2, randomized, double-blind, placebo-controlled, multicenter studyto evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) - MERIDIAN Amyotrophic Lateral Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pegcetacoplam
Product Code: [APL-2]
Other descriptive name: N/A
APELLIS PHARMACEUTCIALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan
6NCT04579666
(ClinicalTrials.gov)
September 30, 202022/9/2020MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis;Motor Neuron DiseaseDrug: Pegcetacoplan (APL-2);Other: PlaceboApellis Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll249Phase 2United States;Australia;Belgium;Czechia;France;Germany;Ireland;Italy;Japan;Netherlands;Poland;Spain;Ukraine;United Kingdom

61. 自己免疫性溶血性貧血


臨床試験数 : 146 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003160-27-HU
(EUCTR)
19/04/202223/02/2022A Randomized, Double-blind, Placebo-controlled Study to Evaluate Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)”A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) Patients with Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: APL-2
Product Name: PEGCETACOPLAN (APL-2)
Product Code: 2019171-69-6
INN or Proposed INN: Pegcetacoplan
Swedish Orphan Biovitrum ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Bulgaria;Georgia;Germany;Norway;Japan
2EUCTR2021-003160-27-ES
(EUCTR)
04/04/202205/04/2022A Randomized, Double-blind, Placebo-controlled Study to Evaluate Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)”A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) Patients with Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: APL-2
Product Name: PEGCETACOPLAN (APL-2)
Product Code: 2019171-69-6
INN or Proposed INN: Pegcetacoplan
Swedish Orphan Biovitrum ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Canada;Bulgaria;Georgia;Germany;Norway;Japan

62. 発作性夜間ヘモグロビン尿症


臨床試験数 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2031220046
28/04/202228/04/2022Pegcetacoplan Long-term Safety and Efficacy Extension StudyAN OPEN-LABEL, NONRANDOMIZED, MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - APL2-307 Paroxysmal Nocturnal Hemoglobinuria (PNH)A subcutaneous dose of pegcetacoplan (APL-2) 1080 mg twice a week, 3 times a week or every 3 daysMachaidze ZurabNULLNot Recruiting>= 18age oldNot applicableBoth10Phase 3the United States;South Korea;Australia;Malaysia;Hong Kong;Philippines;Singapore;Thailand;Peru;Colombia;Mexico;Canada;Bulgaria;Serbia;Belgium;France;Germany;Italy;the Netherlands;Russia;Spain;the United Kingdom;Japan
2JPRN-jRCT2031210645
04/03/202204/03/2022A Phase 3, Randomized, Multicenter, Open-label, Active-comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)A Phase 3, Randomized, Multicenter, Open-label, Active-comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS Paroxysmal Nocturnal Hemoglobinuria (PNH)A subcutaneous dose of pegcetacoplan (APL-2) 1080 mg twice weekly (or change to a dose of 1080 mg every 3 days as necessary).Machaidze ZurabNULLComplete>= 18age oldNot applicableBoth8Phase 3the U.S.;Korea;Australia;Canada;Belgium;France;Germany;Russia;Spain;the United Kingdom;Japan
3NCT04729062
(ClinicalTrials.gov)
April 5, 202125/1/2021Pegcetacoplan Early Access Program for PNHEarly Access Program (EAP) For The Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) With PegcetacoplanParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: PegcetacoplanApellis Pharmaceuticals, Inc.NULLNo longer available18 YearsN/AAllUnited States
4EUCTR2019-001106-23-FR
(EUCTR)
04/02/202015/10/2019An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: APL-2
Product Code: APL-2
INN or Proposed INN: pegcetacoplan
Other descriptive name: APL-2
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
119Phase 3United States;Serbia;Hong Kong;Thailand;Spain;Russian Federation;United Kingdom;France;Canada;Belgium;Malaysia;Poland;Australia;Bulgaria;Germany;Japan;Korea, Republic of
5EUCTR2019-001106-23-ES
(EUCTR)
22/01/202014/01/2020An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: APL-2
Product Code: APL-2
INN or Proposed INN: pegcetacoplan
Other descriptive name: APL-2
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
119 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Poland;Malaysia;Belgium;Australia;Bulgaria;Germany;Japan;Korea, Republic of
6EUCTR2019-001106-23-GB
(EUCTR)
19/12/201930/09/2019An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).An Open Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Pegcetacoplan (APL-2)
Product Code: Pegcetacoplan (APL-2)
INN or Proposed INN: pegcetacoplan
Other descriptive name: Pegcetacoplan (APL-2)
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Serbia;United States;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Malaysia;Australia;Bulgaria;Japan;Korea, Republic of
7NCT04085601
(ClinicalTrials.gov)
August 27, 20199/9/2019A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNHA Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)Paroxysmal Nocturnal HemoglobinuriaDrug: APL-2Apellis Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll53Phase 3Colombia;Hong Kong;Malaysia;Mexico;Peru;Philippines;Poland;Serbia;Singapore;Thailand
8EUCTR2019-001106-23-BG
(EUCTR)
09/08/201909/05/2019An Open-label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)An Open-label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: pegcetacoplan
Product Code: pegcetacoplan
INN or Proposed INN: pegcetacoplan
Other descriptive name: pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Serbia;United States;Hong Kong;Spain;Thailand;Ireland;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Malaysia;Australia;Bulgaria;Netherlands;Germany;Japan;Korea, Republic of
9EUCTR2018-004220-11-PL
(EUCTR)
23/07/201913/05/2019A Research Study to Gather Scientific Information About the Efficacy and Safety of the Investigational Drug APL-2 In Treating Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated with Anemia, In a Randomly Assigned Comparison with the Current Standard of Care Treatment Approved for PNHA Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PRINCE 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: APL-2
Product Code: APL-2
INN or Proposed INN: pegcetacoplan
Other descriptive name: APL-2
Apellis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Phase 3Serbia;Philippines;Hungary;Hong Kong;Mexico;Argentina;Thailand;Malaysia;Brazil;Poland;Peru;Colombia
10EUCTR2017-004268-36-GB
(EUCTR)
08/01/201921/08/2018A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug Pegcetacoplan In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres.A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation.
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Pegcetacoplan (APL-2)
Product Code: Pegcetacoplan (APL-2)
INN or Proposed INN: n/a
Other descriptive name: n/a
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Trade Name: Soliris
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Apellis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of
11NCT03531255
(ClinicalTrials.gov)
August 27, 20189/5/2018Pegcetacoplan Long Term Safety and Efficacy Extension StudyAn Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)PNHDrug: PegcetacoplanApellis Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll160Phase 3United States;Australia;Belgium;Bulgaria;Canada;France;Germany;Hong Kong;Japan;Korea, Republic of;Malaysia;Russian Federation;Serbia;Singapore;Spain;Thailand;United Kingdom
12EUCTR2020-001350-21-CZ
(EUCTR)
08/12/2020A single arm study to evaluate the safety and biological activity of pegcetacoplan in patients 12- 17 years old with paroxysmal nocturnal hemoglobinuriaAn Open-Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients with Paroxysmal Nocturnal Hemoglobinuria Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: pegcetacoplan
Product Code: pegcetacoplan
INN or Proposed INN: Pegcetacoplan
Other descriptive name: pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
12Phase 2Serbia;United States;Czechia;Spain;Thailand;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;Germany;Netherlands
13EUCTR2020-001350-21-NL
(EUCTR)
11/07/2022A single arm study to evaluate the safety and biological activity of pegcetacoplan in patients 12- 17 years old with paroxysmal nocturnal hemoglobinuriaAn Open-Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients with Paroxysmal Nocturnal Hemoglobinuria Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Aspaveli
Product Name: pegcetacoplan
Product Code: pegcetacoplan
INN or Proposed INN: Pegcetacoplan
Other descriptive name: pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
12Phase 2Serbia;United States;Czechia;Thailand;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;Netherlands;Germany
14EUCTR2019-001106-23-DE
(EUCTR)
30/09/2019An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of Pegcetacoplan in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Aspaveli
Product Name: Pegcetacoplan (APL-2)
Product Code: Pegcetacoplan (APL-2)
INN or Proposed INN: pegcetacoplan
Other descriptive name: Pegcetacoplan (APL-2)
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Serbia;Hong Kong;Spain;Thailand;Russian Federation;United Kingdom;France;Canada;Malaysia;Australia;Bulgaria;Germany;Japan;Korea, Republic of

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003767-25-DE
(EUCTR)
08/03/202204/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Aspaveli
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of
2EUCTR2020-003767-25-ES
(EUCTR)
25/02/202225/02/2022A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany;Japan;Korea, Republic of
3EUCTR2020-003767-25-NL
(EUCTR)
16/02/202213/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Germany;Netherlands;Japan;Korea, Republic of
4EUCTR2020-003767-25-PL
(EUCTR)
08/02/202209/11/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Aspaveli
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Australia;Peru;Germany;Netherlands;Japan;Korea, Republic of
5NCT05067127
(ClinicalTrials.gov)
November 12, 202123/9/2021Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisC3G;IC-MPGN;C3 Glomerulopathy;C3 Glomerulonephritis;Complement 3 Glomerulopathy;Complement 3 Glomerulopathy (C3G);Complement 3 Glomerulonephritis;Dense Deposit Disease;DDD;Membranoproliferative Glomerulonephritis;Membranoproliferative Glomerulonephritis (MPGN);Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)Drug: Pegcetacoplan;Other: PlaceboApellis Pharmaceuticals, Inc.NULLRecruiting12 YearsN/AAll90Phase 3Spain;Switzerland;United States;Australia;Belgium;France;Italy;Netherlands;Poland
6EUCTR2020-002637-15-FR
(EUCTR)
09/06/202102/02/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy
7EUCTR2020-002637-15-IT
(EUCTR)
09/04/202104/06/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: [APL-2]
INN or Proposed INN: Pegcetacoplan
Trade Name: Prevenar 13 suspension for injection
Product Name: Prevenar 13 suspension for injection
Product Code: [na]
INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg
Trade Name: Pneumococcal polysaccharide vaccine
Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial
Product Code: [na]
INN or Proposed INN: Pneumococcal Polysaccharide Vaccine
Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide
APELLIS PHARMACEUTCIALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States
8EUCTR2020-002637-15-AT
(EUCTR)
01/04/202123/12/2020Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Aspaveli
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Argentina;Spain;Brazil;Australia;Austria;Netherlands;United Kingdom;Italy;Switzerland
9EUCTR2020-002637-15-NL
(EUCTR)
29/03/202104/01/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Aspaveli
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Italy;Switzerland;United Kingdom
10NCT04572854
(ClinicalTrials.gov)
February 23, 202129/9/2020Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGNC3G;IC-MPGN;Renal Transplant;Complement 3 Glomerulopathy;Complement 3 Glomerulopathy (C3G);Dense Deposit Disease (DDD);Membranoproliferative Glomerulonephritis;Membranoproliferative Glomerulonephritis (MPGN);Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN);C3 Glomerulopathy;C3 Glomerulonephritis;Complement 3 GlomerulonephritisDrug: PegcetacoplanApellis Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll12Phase 2United States;Argentina;Australia;Austria;Brazil;France;Italy;Netherlands;Spain;Switzerland;United Kingdom
11EUCTR2020-002637-15-GB
(EUCTR)
22/12/202023/10/2020Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;Switzerland;Italy;United Kingdom
12EUCTR2020-003767-25-BE
(EUCTR)
19/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of
13EUCTR2020-003767-25-CZ
(EUCTR)
15/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany;Japan;Korea, Republic of
14EUCTR2020-003767-25-FR
(EUCTR)
29/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of
15EUCTR2020-003767-25-AT
(EUCTR)
20/10/2021A Phase 3 study to Evaluate the Efficacy and Safety of Pegcetacoplan administered subcutaneously in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative GlomerulonephritisA Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis - VALIANT complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.0;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Level: PT;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027168;Term: Membranoproliferative glomerulonephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Product Name: Pegcetacoplan
Product Code: APL-2
INN or Proposed INN: Pegcetacoplan
Apellis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Czechia;Finland;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Australia;Peru;Netherlands;Germany;Japan;Korea, Republic of