DDrare: Database of Drug Development for Rare Diseases

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_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-003292-22-NL (EUCTR)	25/07/2017	19/04/2017	Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS)	A randomized, double-blind, placebo-controlled multicenter phase 2 doserangingstudy to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primarySjogren's Syndrome	Primary Sjogren’s syndrome MedDRA version: 21.0;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 Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
2	EUCTR2016-003292-22-BE (EUCTR)	17/07/2017	26/04/2017	Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS)	A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome.	Primary Sjogren’s syndrome MedDRA version: 20.0;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 Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab Other descriptive name: VAY736 antibody	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
3	EUCTR2016-003292-22-HU (EUCTR)	29/06/2017	20/04/2017	Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)	A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome	Primary Sjogren’s syndrome MedDRA version: 20.0;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: VAY736 INN or Proposed INN: Not established Other descriptive name: VAY736 antibody	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden
4	EUCTR2016-003292-22-AT (EUCTR)	19/06/2017	17/05/2017	Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)	A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome	Primary Sjogren’s syndrome MedDRA version: 21.0;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 Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
5	EUCTR2016-003292-22-GB (EUCTR)	26/05/2017	20/03/2017	Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)	A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome	Primary Sjogren’s syndrome MedDRA version: 21.0;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 Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
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	EUCTR2016-003292-22-ES (EUCTR)	06/04/2017	10/03/2017	Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)	A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome	Primary Sjogren’s syndrome MedDRA version: 19.1;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: VAY736 INN or Proposed INN: Not established Other descriptive name: VAY736 antibody	Novartis Farmacéutica, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Chile;Portugal;United States;Taiwan;Spain;Austria;Russian Federation

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

EUCTR2016-003292-22-NL
(EUCTR)

25/07/2017

19/04/2017

Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS)

A randomized, double-blind, placebo-controlled multicenter phase 2 doserangingstudy to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primarySjogren's Syndrome

Primary Sjogren’s syndrome
MedDRA version: 21.0;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 Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan

EUCTR2016-003292-22-BE
(EUCTR)

17/07/2017

26/04/2017

Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS)

A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome.

Primary Sjogren’s syndrome
MedDRA version: 20.0;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 Name: Ianalumab
Product Code: VAY736
INN or Proposed INN: Ianalumab
Other descriptive name: VAY736 antibody

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan

EUCTR2016-003292-22-HU
(EUCTR)

29/06/2017

20/04/2017

Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)

A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome

Product Code: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden

EUCTR2016-003292-22-AT
(EUCTR)

19/06/2017

17/05/2017

Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)

A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome

Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan

EUCTR2016-003292-22-GB
(EUCTR)

26/05/2017

20/03/2017

Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)

Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan

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

EUCTR2016-003292-22-ES
(EUCTR)

06/04/2017

10/03/2017

Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)

A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome

Primary Sjogren’s syndrome
MedDRA version: 19.1;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: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody

Novartis Farmacéutica, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Chile;Portugal;United States;Taiwan;Spain;Austria;Russian Federation