DDrare: Database of Drug Development for Rare Diseases

53. シェーグレン症候群
［臨床試験数：234，薬物数：270（DrugBank：85），標的遺伝子数：49，標的パスウェイ数：174］

Searched query = "Sjogren syndrome", "Sjögren syndrome"
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 = 0.005% Lacripep; 0.01% Lacripep; 0.02% Fm, SH; 0.02% Fm, SH, 0.05% CsA; 0.02% Fm, SH, AS; 0.9% sodium chloride; 13-valent pneumococcal conjugate vaccine; 1643368-58-4; 18F-FDG; 23-valent pneumococcal polysaccharide vaccine; 552-02; ABATACEPT; ABBV-323; ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED; AMG 557/MEDI5872; AS; ASCs; Abatacept; Abatacept Placebo; Abatacept SC; Acycloguanosine; Alginate; Allogeneic Mesenchymal Stem Cells (AlloMSC); Allogeneic Stem Cell Transplant; Allogeneic adipose tissue-derived stromal/stem cells; Aloe vera; Anti-CD28dAb; Anti-CD28dab; Anti-pandemic H1N1 influenza vaccine; Artificial Saliva; Autologous Serum 20%; Autologous Serum 50%; Autologous Stem Cell Transplant; Autologous serum; Aún no establecido; B / Phuket / 3073/2013-like virus); BELIMUMAB; BENLYSTA; BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO; BMS-188667; BMS-931699; BMS-986142; BMS-986195; BMS986142; BMS986195; BTK Inhibitor; BUPI5; BUPIVACAINE HYDROCHLORIDE; Baminercept; Belimumab; Benlysta; Benlysta (Belimumab); Biopsy of the labial salivary gland; Blood sample; Branebrutinib; Bupivacaine; Bupizenge; CDZ173; CFZ533; CFZ533 (iscalimab); CFZ533 active - Cohort 1; CFZ533 active - Cohort 2; CFZ533 active - Cohort 3; CFZ533 active -Cohort 3; CICLOSPORIN; CO; CSCC_ASC(22); Calcium; Calcium carbonate; Calcium carbonate D; Carbomer; Carbomer 974P; Carbonate; Cathepsin S; Cathepsin S Inhibitor; Cathepsin S inhibitor; Cellulose; Cevimeline; Chloride; Ciclosporin; Citric Acid based Mouthwash; Citric acid; Coconut; Cryostor CS10; CsA; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine A; Cyclosporins; Dehydroepiandrosterone; Dexamethasone; Dexamethasone Parotid Irrigation; Diquafosol; Dornase alfa; E4; EFALIZUMAB; Efalizumab; Endura; Estetrol; Etanercept; FILGOTINIB; FMP-30; Filgotinib; GS-4059; GS-6034; GS-9876; GSK2618960; GSK2618960 2 mg/kg; Gadoterate; Ginseng; Glycyrrhiza; Gold; HGS1006, LymphoStat-B; HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA; HYDROCORTISONE SODIUM PHOSPHATE; HYDROXYCHLOROQUINE; HrIL-2 active; Hyaluronate; Hyaluronic acid; Hydrocortisone; Hydroxychloroquine; IL-2; ISCALIMAB; Ianalumab; Iguratimod; Ikervis; Impact; Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; Iscalimab; KCT-0809 ophthalmic solution; Korean Red Ginseng; LEFLUNOMIDE; LO2A eye drops; LOU064; LY3090106; Lacryvisc; Lanraplenib; Leflunomide; Leflunomide Mylan; Leflunomide mylan; Leniolisib; Levocarnitine; Levofloxacin; Licorice; LimphoStat-B; Lipitor®; Liposic; MABTHERA; MABTHERA - 1 FIALA 500 MG 50 ML; MEDI4920; METILPREDNISOLONE; MabThera; MabThera (Rituximab); MabThera (rituximab); Maxidex; Meglumine; Methotrexate; Methyl cellulose; MighTeaFlow; Mizoribine; Mucosta; Mycophenolate; Mycophenolate mofetil; Mycophenolate sodium; NGX267; NaCl 0,9%; Nivolumab; ORENCIA; ORENCIA 125 mg solution for injection in pre-filled syringe; OSE-127; Olive; Olive Oil; Olive oil; Omalizumab; Ophthalmic Emulsion; Orencia; Other: 0.02% Fm, SH, tBCL; Other: No treatment; Other: autologous serum and rebamipide 2%; Other: carboxy methyl cellulose; Other: natural herbs of coconut, aloe vera, and pepperint; P-552; PAH; PARACETAMOLO; PRP injection; Parsaclisib; Phosphate; Pilocarpine; Pilocarpine Hydrochloride; Plaquenil; Prednisone; Privigen 100 mg/ml, solution pour perfusion; Privigen® 100mg/ml at the dose of 2g/kg of body weight; Probiotic Product - Cap; Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine; Procedure: Minor Salivary gland (labial) biopsy; Procedure: Sialoendoscopy; Procedure: pilocarpine; RC18 160 mg; RC18 240 mg; RITUXIMAB; RO545-9072/F03; RO5459072; RSLV-132; Radiation: 11C-MET PET/CT Imaging; Radiation: 18F-FDG PET/CT Imaging; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Ravagalimab; Rebamipide; Refresh Endura; Remibrutinib; Restasis; Rituxan (US, Canada, Japan), MabThera (rest of world); Rituximab; Rituximab (anti-CD20); Rituximab, Mabthera; S95011; S95011 concentrate for solution for infusion; SALINE; SAR441344; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; SOLU-MEDROL; SS-1; SVS20; Saline; Sandimmun Optoral; Sodium chloride; Sodium hyaluronate; Softacort; Solu-Medrol; Solu-medrol; Standard care Hyaluronic acid eye drops; Sulfate; Systane Ultra UD; TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE; TCM (Gan-Lu-Yin)GLY; Tachipirina; Tacrolimus; Tears Naturale Forte; Tetracycline; Thalidomide; Thymosin Beta 4 eye drops; Thymosin beta 4; Tibulizumab; Tibulizumab (LY3090106); Tirabrutinib; Tocilizumab; Tofacitinib; UCB5857; Ustekinumab; VAY736; VAY736 antibody; VAY736 higher dose; VAY736 lower dose; VIB4920; VIB7734; Vehicle Control; Vitamin A; Vitamin D3; Water; XYZAL - 20 COMPRESSE RI; Xeros; Xylitol; Xyzal; Yellow Fever Vaccine; Yellow Fever vaccine (17D); [NA]; [na]

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	EUCTR2014-004616-12-PL (EUCTR)	21/11/2016	12/10/2016	Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173	A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome	Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173	Novartis Pharma Services AG	NULL	Not Recruiting	Female: yes Male: yes	30	Phase 2	Hungary;Poland;Germany
2	EUCTR2014-004616-12-HU (EUCTR)	28/09/2016	17/08/2016	Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173	A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome	Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173	Novartis Pharma Services AG	NULL	Not Recruiting	Female: yes Male: yes	30	Phase 2	Hungary;Poland;Germany
3	EUCTR2014-004616-12-DE (EUCTR)	20/05/2016	17/03/2016	Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173	A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome	Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173	Novartis Pharma Services AG	NULL	Not Recruiting	Female: yes Male: yes	30	Phase 2	Hungary;Poland;Germany

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

EUCTR2014-004616-12-PL
(EUCTR)

21/11/2016

12/10/2016

Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173

A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome

Primary Sjögren's syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Germany

EUCTR2014-004616-12-HU
(EUCTR)

28/09/2016

17/08/2016

Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Germany

EUCTR2014-004616-12-DE
(EUCTR)

20/05/2016

17/03/2016

Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Germany