PHA-022121 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
65Primary immunodeficiency12

65. Primary immunodeficiency


Clinical trials : 500 Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217
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PhaseCountries
1NCT05396105
(ClinicalTrials.gov)
December 28, 202228/4/2022Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary AngioedemaA Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-Inhibitor Deficiency (Type I or Type II)Hereditary Angioedema;Hereditary Angioedema Type I;Hereditary Angioedema Type II;Hereditary Angioedema Types I and II;Hereditary Angioedema Attack;Hereditary Angioedema With C1 Esterase Inhibitor Deficiency;Hereditary Angioedema - Type 1;Hereditary Angioedema - Type 2;C1 Esterase Inhibitor [C1-INH] Deficiency;C1 Esterase Inhibitor Deficiency;C1 Esterase Inhibitor, Deficiency of;C1 Inhibitor DeficiencyDrug: PHA-022121 low dose;Drug: PHA-022121 medium dose;Drug: PHA-022121 high dose;Drug: PHA-022121 selected dosePharvaris Netherlands B.V.NULLRecruiting18 YearsN/AAll72Phase 2/Phase 3United States;Bulgaria;Czechia;France;Germany;Hungary;Spain
2EUCTR2021-006906-58-HU
(EUCTR)
11/07/202213/05/2022An extension phase 2/3 study to test the safety of long term administration of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedemaA Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II) - RAPIDe-2 Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2;Phase 3France;United States;Czechia;Hungary;Canada;Spain;Poland;Bulgaria;Israel;Germany;United Kingdom;Italy
3NCT05047185
(ClinicalTrials.gov)
April 19, 20227/9/2021Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type IIA Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Due to C1-Inhibitor Deficiency (Type I or Type II)Hereditary Angioedema;Hereditary Angioedema Type I;Hereditary Angioedema Type II;Hereditary Angioedema Types I and II;Hereditary Angioedema Attack;Hereditary Angioedema With C1 Esterase Inhibitor Deficiency;Hereditary Angioedema - Type 1;Hereditary Angioedema - Type 2;C1 Esterase Inhibitor Deficiency;C1 Inhibitor DeficiencyDrug: PHA-022121 low dose;Drug: PHA-022121 high dose;Drug: PlaceboPharvaris Netherlands B.V.NULLRecruiting18 Years75 YearsAll30Phase 2United States;Bulgaria;Canada;Germany;Israel;Italy;Poland;Spain;United Kingdom
4EUCTR2021-000227-13-BG
(EUCTR)
07/03/202202/12/2021A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for prophylaxis of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II) - HAE CHAPTER-1 Hereditary angioedema due to C1-Inhibitor Deficiency (Type I or Type II)
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 24.0;Level: LLT;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
INN or Proposed INN: Not established
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Canada;Austria;United States;Ireland;Poland;Italy;United Kingdom;Israel;Bulgaria;Germany;Spain
5EUCTR2021-000227-13-PL
(EUCTR)
02/02/202218/11/2021A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for prophylaxis of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II) - HAE CHAPTER-1 Hereditary angioedema due to C1-Inhibitor Deficiency (Type I or Type II)
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 24.0;Level: LLT;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
INN or Proposed INN: Not established
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Canada;Poland;Israel;Bulgaria;Germany;United Kingdom
6EUCTR2020-003445-11-NL
(EUCTR)
14/04/202101/12/2020A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with hereditary angioedema due to C1-Inhibitor Deficiency type I and II - RAPIDe-1 Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Bulgaria;Netherlands;Germany
7EUCTR2020-003445-11-BG
(EUCTR)
14/04/202102/03/2021A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with hereditary angioedema due to C1-Inhibitor Deficiency type I and II - RAPIDe-1 Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Bulgaria;Germany;Netherlands
8EUCTR2020-003445-11-DE
(EUCTR)
26/02/202111/02/2021A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with hereditary angioedema due to C1-Inhibitor Deficiency type I and II - RAPIDe-1 Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands
9EUCTR2020-003445-11-PL
(EUCTR)
23/02/202103/12/2020A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with hereditary angioedema due to C1-Inhibitor Deficiency type I and II - RAPIDe-1 Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLNot RecruitingFemale: yes
Male: yes
72Phase 2United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Bulgaria;Netherlands;Germany
10EUCTR2020-003445-11-HU
(EUCTR)
27/01/202130/11/2020A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with hereditary angioedema due to C1-Inhibitor Deficiency type I and II - RAPIDe-1 Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2France;Hungary;Canada;Spain;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy
11EUCTR2020-003445-11-FR
(EUCTR)
18/12/202022/10/2020A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with hereditary angioedema due to C1-Inhibitor Deficiency type I and II - RAPIDe-1 Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2France;Czech Republic;Hungary;Canada;Spain;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy
12EUCTR2020-003445-11-CZ
(EUCTR)
11/02/2021A blinded, placebo-controlled and randomized phase 2 study to test different doses of oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema (HAE).A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with hereditary angioedema due to C1-Inhibitor Deficiency type I and II - RAPIDe-1 Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;Classification code 10080957;Term: Hereditary angioedema C1 inhibitor deficiency;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: PHVS416
Product Code: PHA-022121
Other descriptive name: PHA-022121
Pharvaris Netherlands BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands