Neod001    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
28Systemic amyloidosis14

28. Systemic amyloidosis    [ 212 clinical trials,   234 drugs,   (DrugBank: 72 drugs),   54 drug target genes,   170 drug target pathways]
Searched query = "Systemic amyloidosis", "AL amyloidosis", "Immunoglobulin light chain amyloidosis", "Amyloid light-chain amyloidosis", "Familial amyloidosis", "Familial amyloid polyneuropathy", "Senile transthyretin amyloidosis", "Senile TTR amyloidosis"
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.
14 / 212 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004664-18-DE
(EUCTR)
09/02/201824/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
2EUCTR2016-004664-18-AT
(EUCTR)
07/11/201720/09/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Australia;Austria;Israel;Germany;Italy;United Kingdom;United States;Greece;Spain
3EUCTR2016-004664-18-GR
(EUCTR)
27/09/201702/06/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
4EUCTR2016-004664-18-GB
(EUCTR)
08/08/201709/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
5EUCTR2016-004664-18-ES
(EUCTR)
31/07/201729/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;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
6NCT03154047
(ClinicalTrials.gov)
June 14, 201728/4/2017Study in Subjects With Light Chain (AL) AmyloidosisA Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Who Were Previously Enrolled in Study NEOD001-201 (PRONTO)AL AmyloidosisDrug: NEOD001Prothena Therapeutics Ltd.NULLTerminated18 YearsN/AAll80Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom
7EUCTR2015-004318-14-AT
(EUCTR)
07/07/201622/08/2016A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2France;United States;Greece;Spain;Australia;Austria;Israel;Germany;Italy;United Kingdom
8EUCTR2015-004318-14-DE
(EUCTR)
13/06/201626/11/2015A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Greece;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy
9EUCTR2015-004318-14-GR
(EUCTR)
21/04/201611/02/2016A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 18.1;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom
10EUCTR2015-004318-14-ES
(EUCTR)
10/03/201618/03/2016A study is to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis or primary systemic amyloidosis, involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains by plasma cells results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs of individuals with AL amyloidosis.
MedDRA version: 18.1;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Germany;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
11NCT02632786
(ClinicalTrials.gov)
March 20169/12/2015The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) AmyloidosisA Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac DysfunctionAL AmyloidosisDrug: NEOD001;Drug: PlaceboProthena Therapeutics Ltd.NULLCompleted18 YearsN/AAll129Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom
12EUCTR2015-004318-14-GB
(EUCTR)
05/02/201627/11/2015A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0;Level: PT;Classification code 10036673;Term: Primary amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
13NCT02613182
(ClinicalTrials.gov)
February 201618/11/2015Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) AmyloidosisOpen-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) AmyloidosisAL AmyloidosisDrug: NEOD001Prothena Therapeutics Ltd.NULLTerminatedN/AN/AAll34Phase 2United States
14NCT02312206
(ClinicalTrials.gov)
February 20152/12/2014The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL AmyloidosisA Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) AmyloidosisPrimary Systemic (AL) AmyloidosisDrug: NEOD001;Other: PlaceboProthena Therapeutics Ltd.NULLTerminated18 YearsN/AAll260Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom