DDrare: Database of Drug Development for Rare Diseases

Searched query = "Giant cell arteritis", "Temporal arteritis"
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.

Drug = 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione; 18F-FDG; ABT-494; AIN457; ANAKINRA; Abatacept; Adalimumab; Alendronate; Alendronate versus alfacalcidol (1-alpha OH vitamin D); Alfacalcidol; Anakinra; Anti-thymocyte globulin; BOSENTAN MYLAN; Baricitinib; Blood samples; Bosentan; CNTO 136; CORTANCYL; Combination Product: mavrilimumab; Cortancyl; Cortancyl ® 1 mg; Cortancyl ® 20 mg; Cortancyl ® 5 mg; Corticoids+ tocilizumab 8mg/Kg/4 weeks; Corticosteroid (CS); Corticosteroids; Corticosteroids for Systemic Use; Cosentyx; Cyclophosphamide; Cyclosporine; Diagnostic Test: 68-Ga HA-DOTATATE PET/CT; Dotatate; Encorton; Filgrastim; GSK2973327; Gevokizumab; Glucocorticoid Treatment; Glucocorticoids; Guselkumab; Hydroxychloroquine; Infliximab; KINERET; KPL-301; Kevzara; Kevzara ®; Kineret; Lodotra; Lodotra (delayed release prednisolone); MAVRILIMUMAB; METOJECT; Mavrilimumab; Methotrexate; Methotrexate treatment; Methylprednisolone; Naltrexone; Naltrexone Hydrochloride; Nivolumab; Other: 18F-FDG PET/CT; Other: IV steroids combination alone; Other: Questionnaires; Other: questionnaires; Over encapsulated prednisone; PET10; PET3; PREDNISOLONE; PREDNISONE; Pr; PredniSONE Tablets USP, 1 mg; PredniSONE Tablets USP, 2.5 mg; PredniSONE Tablets USP, 5 mg; PredniSONE Tablets, USP; Prednisolon 1 mg JENAPHARM; Prednisolon 5 mg JENAPHARM; Prednisolone; Prednisolone 5 mg JENAPHARM; Prednisone; Prednisone Capsules; Prednisone Tablets, USP; Prednisone and ustekinumab treatment; Prednisone therapy and pharmacokinetic; Prednisone treatment; Procedure: Autologous Peripheral Blood Stem Cell Transplantation; Rituximab; Ro 001-9265; Ro 001-9265/F02; Ro 001-9265/F03; Ro 001-9265/F04; Ro 487-7533/F10-04; RoActemra; RoActemra 162 mg solution for injection in pre-filled syringe; S78989; SAR153191; SARILUMAB; SECUKINUMAB; Sarilumab; Sarilumab SAR153191; Secukinumab; Secukinumab 300 mg, s.c.; Sirukumab; TOCILIZUMAB; TOCILIZUMAB SC; Tocilizumab; Tocilizumab + Glucocorticoids (GCs); Tocilizumab SC; Tocilizumab and IV steroids combination; Tocilizumab treatment; Treatment; Upadacitinib; Ustekinumab; Vitamin D; XOMA 052

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-001003-36-DE (EUCTR)	27/02/2019	21/06/2018	A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis	A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis	giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A	Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
2	NCT03827018 (ClinicalTrials.gov)	December 21, 2018	25/1/2019	KPL-301 for Subjects With Giant Cell Arteritis	A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis	Giant Cell Arteritis	Combination Product: mavrilimumab;Combination Product: placebo	Kiniksa Pharmaceuticals, Ltd.	NULL	Active, not recruiting	50 Years	85 Years	All	70	Phase 2	United States;Australia;Belgium;Croatia;Estonia;Germany;Ireland;Italy;Netherlands;New Zealand;Poland;Serbia;Slovenia;Spain;United Kingdom
3	EUCTR2018-001003-36-GB (EUCTR)	06/12/2018	20/06/2018	A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis	A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis	giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: Prednisone Tablets, USP Product Code: N/A INN or Proposed INN: n/a Other descriptive name: PREDNISONE	Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 2	United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
4	EUCTR2018-001003-36-SI (EUCTR)	03/10/2018	30/08/2018	A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis	A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis	giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A	Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand
5	EUCTR2018-001003-36-ES (EUCTR)	08/08/2018	28/06/2018	A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis	A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis	giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A	Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2018-001003-36-EE (EUCTR)	09/07/2018	11/06/2018	A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis	A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis	giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A	Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-001003-36-DE
(EUCTR)

27/02/2019

21/06/2018

A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis

A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis

giant cell arteritis
MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: PredniSONE Tablets, USP
Product Code: N/A

Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand

NCT03827018
(ClinicalTrials.gov)

December 21, 2018

25/1/2019

KPL-301 for Subjects With Giant Cell Arteritis

A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis

Giant Cell Arteritis

Combination Product: mavrilimumab;Combination Product: placebo

Kiniksa Pharmaceuticals, Ltd.

NULL

Active, not recruiting

50 Years

85 Years

All

Phase 2

United States;Australia;Belgium;Croatia;Estonia;Germany;Ireland;Italy;Netherlands;New Zealand;Poland;Serbia;Slovenia;Spain;United Kingdom

EUCTR2018-001003-36-GB
(EUCTR)

06/12/2018

20/06/2018

A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis

A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis

Product Name: Mavrilimumab
Product Code: KPL-301
INN or Proposed INN: MAVRILIMUMAB
Other descriptive name: n/a
Trade Name: Prednisone Tablets, USP
Product Name: Prednisone Tablets, USP
Product Code: N/A
INN or Proposed INN: n/a
Other descriptive name: PREDNISONE

Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand

EUCTR2018-001003-36-SI
(EUCTR)

03/10/2018

30/08/2018

A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis

A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis

Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand

EUCTR2018-001003-36-ES
(EUCTR)

08/08/2018

28/06/2018

A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis

A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis

Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-001003-36-EE
(EUCTR)

09/07/2018

11/06/2018

A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis

A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis

Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand