DDrare: Database of Drug Development for Rare Diseases

84. サルコイドーシス
［臨床試験数：143，薬物数：221（DrugBank：79），標的遺伝子数：82，標的パスウェイ数：165］

Searched query = "Sarcoidosis"
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 = 1% lignocaine; 13NH3 PET/CT scan; 18F-FDG; 18F-FSPG; 18F-fluorodeoxyglucose; 18FDG PET/CT scan; 2% lignocaine; 68Ga-DOTANOC; 68Ga-DOTATATE; 68Ga-DOTATATE PET/CT; 99m technetium infliximab; 99mTc-Infliximab; ABPC; ACT-293987 / JNJ-67896049; ACTHAR Gel (adrenocorticotropic hormone); ACTHAR Gel 40 units twice weekly; ACTHAR Gel 80 units twice weekly.; ACZ885; AMPC; ARA 290; ATYR1923; ATYR1923 1.0 mg/kg; ATYR1923 3.0 mg/kg; ATYR1923 5.0 mg/kg; Abatacept; Acthar; Acthar Gel; Acthar gel; Adalimumab; Adrenocorticotropic hormone; All subjects will receive maraviroc 300mg orally twice a day for 6 weeks; Allogeneic stem cell transplantation; Ambrisentan; Anakinra; Analysis of gamma globulin; Antibiotic Regimen; Antituberculous therapy along with steroids; Armodafinil; Atorvastatin; Autologous hematopoietic stem cell transplantation; Azithromycin; Azithromycin 250Mg Capsule; Azithromycin monohydrate; BAL; Bardoxolone; Bardoxolone methyl; Blood sample; Bosentan; Bosentan monohydrate; C11-methionine; CC; CC-100004; CC-220; CC-220 0.3 mg Daily; CC-220 0.6mg Daily; CMK389; CNTO 148; CNTO1275; CNTO148; Calcium; Calcium Citrate with Vitamin D2; Calcium citrate; Canakinumab; Ciclesonide; Clarithromycin; Corticosteroid; Corticotropin; Cu-64 DOTATATE; Cyclophosphamide; Cysteine; D-methylphenidate; DELTACORTENE*10CPR 25MG; DEXAMETHASONE; DOTANOC; Dapsone; Device: Blood pressure; Device: Flexible bronchoscopy in moderate sedation; Device: Nested PCR for formalin-fixed tissues; Device: Nested PCR for fresh tissues; Device: Oxygen saturation; Device: Propofol dosage; Device: Real-time PCR for fresh tissues; Device: Recovery time after bronchoscopy; Dexamethasone; Dexamethasone 0,5mg; Diagnostic Test: 18F-FDG-PET/MRI; Diagnostic Test: 18F-GE180-PET/MRI; Diagnostic Test: 68Ga-DOTA-TOC PET/CT; Diagnostic Test: FDG-PET/CT with Rb82 Myocardial Perfusion Imaging; Diagnostic Test: Laboratory testing; Diagnostic Test: Spirometry; Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imaging; Dotatate; Doxycycline; Ergocalciferol; Ethambutol; FDG; FLUORINE (18F) FLUDEOXYGLUCOSE; Fermented oyster extract; Fludeoxyglucose; Fluorodeoxyglucose; Folic acid; Formalin; Ga-68-DOTA-NOC; Gallium-68 DOTATATE; Gallium-68-DOTA-N-Octreotide; Genetic: RNA Sequencing; Glucocorticoid (prednisone or prednisolone); Gold; Golimumab; Golimumab Liquid in prefilled syringe; H.P. Acthar Gel; Habitrol; Heparin; Human anti TNF-alpha monoclonal antibody; Human anti-IL 12/23 monoclonal antibody; Humira; Hydroxychloroquine; Hydroxychloroquine + Prednisone; ILARIS; IMod.Fc, H-Fcv3-N4; Ilaris; Iloprost; Indium; Indium-111 Pentreotide; Infliximab; Influenza Vaccine; Inhaled Treprostinil; L-METHIONINE ([11C]METHYL); L-methionine; Levaquin; Levofloxacin; Lignocaine; Low dose prednisolone; METHOTREXATE; MTX; Maraviroc; Medium dose prednisolone; Methionine; Methotrexate; Methylphenidate; Methylphenidate (overencapsulated); Methylphenidate 10mg tablets; Methylprednisolone; Methylprednisolone bolus IV 15 mg/kg/d for 3 days.; Minomycin; Mycophenolate; N-acetyl-cysteine; Nelutri™; Nicotine; Nicotine patch; None; OCTREOTIDE; ORENCIA; Octreotide; Octreotide LAR / Sandostatin LAR (LAR=long acting release); Orencia; Other: 18F-FDG; Other: 18F-Fluorodeoxyglucose (18F-FDG) PET/CT; Other: Normal Saline for injection; Oxygen; Oyster; PD 0360324; PDA001 (cenplacel-L); PLAQUENIL*25CPR RIV 200MG; PREDNISONE; Pentoxifylline; Pirfenidone; Prednisolone; Prednison; Prednisone; Procedure: Bronchoalveolar lavage (BAL); Procedure: Bronchoscopy with bronchoalveolar lavage; Procedure: EBB + TBLB + BAL; Procedure: EBUS guided transbronchial forceps biopsy (EBUS-TBFB); Procedure: EBUS guided transbronchial needle aspiration (EBUS-TBNA); Procedure: EUS-FNA/EBUS-TBNA + BAL; Procedure: Endobronchial forceps biopsy; Procedure: Skin biopsy; Procedure: large bore (19G) histologic needle biopsy of the mediastinal lymph nodes; Procedure: venipunctures; Propofol; Quercetin; Radiation: Rubidium PET; Rapamune; Remicade; Repository Corticotropin Injection; Repository Corticotropin Injection -Treatment Extension; Rifampin; Rifampin and azithromycin.; Riociguat; Rituximab; Roflumilast; Rubidium; SELEXIPAG; SIROLIMUS; Sandostatin LAR; Sarilumab; Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1; Schisandra chinensis extract; Seasonal influenza vaccine available for the 2012-2013 vaccine campaign; Selexipag; Sirolimus; Sirolimus Ointment; THALIDOMIDE; Tadalafil; Thalidomide; Tofacitinib; Tofacitinib 5 mg twice daily; Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial; Tofacitinib 5mg [Xeljanz] 1 year open-label extension; Tracleer; Tranilast; Treprostinil; Uptravi; Ursodeoxycholic Acid; Ursodeoxycholic acid; Ustekinumab; Ustekinumab liquid in prefilled syringe; Vitamin D2; Water

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-004887-74-DE (EUCTR)	20/05/2020	17/06/2019	A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.	A Multicenter, Randomized, Double-blind, Placebo-controlled study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.	sarcoidosis-associated pulmonary hypertension (SAPH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 / JNJ-67896049 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	74	Phase 2	United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Germany;Netherlands
2	EUCTR2018-004887-74-GB (EUCTR)	14/08/2019	03/06/2019	A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.	A Multicenter, Randomized, Double-blind, Placebo-controlled Study inParticipants with Sarcoidosis-associated Pulmonary Hypertension (SAPH)to Assess the Efficacy and Safety of Oral Selexipag.	sarcoidosis-associated pulmonary hypertension (SAPH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 / JNJ-67896049 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	74	Phase 2	United States;Czechia;Spain;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Germany;Netherlands
3	EUCTR2018-004887-74-NL (EUCTR)	29/07/2019	05/06/2019	A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.	A Multicenter, Randomized, Double-blind, Placebo-controlled Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.	sarcoidosis-associated pulmonary hypertension (SAPH) MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 / JNJ-67896049 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	74	Phase 2	United States;France;Hungary;Canada;Poland;Spain;Brazil;Belgium;Germany;Netherlands;United Kingdom;Italy

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

EUCTR2018-004887-74-DE
(EUCTR)

20/05/2020

17/06/2019

A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.

A Multicenter, Randomized, Double-blind, Placebo-controlled study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.

sarcoidosis-associated pulmonary hypertension (SAPH)
MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Germany;Netherlands

EUCTR2018-004887-74-GB
(EUCTR)

14/08/2019

03/06/2019

A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.

A Multicenter, Randomized, Double-blind, Placebo-controlled Study inParticipants with Sarcoidosis-associated Pulmonary Hypertension (SAPH)to Assess the Efficacy and Safety of Oral Selexipag.

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Czechia;Spain;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Germany;Netherlands

EUCTR2018-004887-74-NL
(EUCTR)

29/07/2019

05/06/2019

A study of the effectiveness and safety of selexipag in patients with sarcoidosis-associated pulmonary hypertension.

A Multicenter, Randomized, Double-blind, Placebo-controlled Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987 / JNJ-67896049
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Hungary;Canada;Poland;Spain;Brazil;Belgium;Germany;Netherlands;United Kingdom;Italy