Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Sjogren's Syndrome
Treatment
CFZ533 (iscalimab)
CFZ533 Placebo
Iscalimab
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants had to have participated in the TWINSS core study, CCFZ533B2201 (NCT03905525), and had to have completed the entire treatment period up to Week 48and the follow-up period up to Week 60.
Signed informed consent had to be obtained prior to participation in the Extensionstudy (i.e., before commencement of the Week 60 assessments of the core study).
In the judgment of the Investigator, participants had to be expected to clinicallybenefit from continued iscalimab therapy.
Exclusion
Exclusion Criteria:
- Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic diseaseconstituted the principle illness, specifically:
Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNApositivity and renal involvement, or other organ involvement that impeded onthe ability to score ESSDAI domains
Active rheumatoid arthritis (RA) that impeded on the ability to score theESSDAI articular domain
Systemic sclerosis
Any other concurrent connective tissue disease (e.g., lupus nephritis (LN),large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)that was active and required immunosuppressive treatment outside the scope ofthis trial and would impede on Sjögren's Syndrome organ domain assessments
Use of other investigational drugs other than iscalimab during the core study
Active uncontrolled viral, bacterial or other infections requiring systemictreatment at the time of enrollment, or history of recurrent clinically significantinfection or of bacterial infections with encapsulated organisms
Pregnant or nursing (lactating) women, where pregnancy was defined as the state of afemale after conception and until the termination of gestation, confirmed by apositive human Chorionic Gonadotropin (hCG) laboratory test
Women of child-bearing potential (WOCBP), defined as all women physiologicallycapable of becoming pregnant, unless they were using highly effective methods ofcontraception during dosing and for 14 weeks after stopping the investigationaldrug.
Missing ESSDAI (Cohort 1 and Cohort 2) or ESSPRI (Cohort 2) scores in the core studyat Weeks 0 and 4 or Weeks 40 and 48.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires 3435907 C1055AAF
ArgentinaSite Not Available
Novartis Investigative Site
CABA, 1426
ArgentinaSite Not Available
Novartis Investigative Site
Nedlands, Western Australia 6009
AustraliaSite Not Available
Novartis Investigative Site
Nedlands 2064874, Western Australia 2058645 6009
AustraliaSite Not Available
Novartis Investigative Site
Graz, 8036
AustriaSite Not Available
Novartis Investigative Site
Graz 2778067, 8036
AustriaSite Not Available
Novartis Investigative Site
Vienna 2761369, 1090
AustriaSite Not Available
Novartis Investigative Site
Wien, 1090
AustriaSite Not Available
Novartis Investigative Site
Vitoria, ES 29055 450
BrazilSite Not Available
Novartis Investigative Site
Vitória 3444924, Espírito Santo 3463930 29055 450
BrazilSite Not Available
Novartis Investigative Site
Juiz de Fora, MG 36010 570
BrazilSite Not Available
Novartis Investigative Site
Juiz de Fora 3459505, Minas Gerais 3457153 36010 570
BrazilSite Not Available
Novartis Investigative Site
Sao Paulo, SP 01244-030
BrazilSite Not Available
Novartis Investigative Site
São Paulo, SP 01244-030
BrazilSite Not Available
Novartis Investigative Site
São Paulo 3448439, São Paulo 3448433 01244-030
BrazilSite Not Available
Novartis Investigative Site
Toronto, Ontario M5T 2S8
CanadaSite Not Available
Novartis Investigative Site
Toronto 6167865, Ontario 6093943 M5T 2S8
CanadaSite Not Available
Novartis Investigative Site
Rimouski, Quebec G5L 5T1
CanadaSite Not Available
Novartis Investigative Site
Trois Rivieres, Quebec G9A 3Y2
CanadaSite Not Available
Novartis Investigative Site
Rimouski 6354895, Quebec 6115047 G5L 5T1
CanadaSite Not Available
Novartis Investigative Site
Trois-Rivières 6169141, Quebec 6115047 G9A 3Y2
CanadaSite Not Available
Novartis Investigative Site
Valdivia, Los Rios 5110683
ChileSite Not Available
Novartis Investigative Site
Valdivia 3868707, Los Ríos Region 6693563 5110683
ChileSite Not Available
Novartis Investigative Site
Santiago, 7500571
ChileSite Not Available
Novartis Investigative Site
Santiago 3871336, 7500710
ChileSite Not Available
Novartis Investigative Site
Medellin, Antioquia 050001
ColombiaSite Not Available
Novartis Investigative Site
Medellín 3674962, Antioquia 3689815 050001
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla, Atlantico 080002
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla 3689147, Atlántico 3689436 080002
ColombiaSite Not Available
Novartis Investigative Site
Brest, 29200
FranceSite Not Available
Novartis Investigative Site
Brest 3030300, 29200
FranceSite Not Available
Novartis Investigative Site
Le Kremlin Bicetre, 94275
FranceSite Not Available
Novartis Investigative Site
Le Kremlin-Bicêtre 3003737, 94275
FranceSite Not Available
Novartis Investigative Site
Lille, 59037
FranceSite Not Available
Novartis Investigative Site
Lille 2998324, 59037
FranceSite Not Available
Novartis Investigative Site
Strasbourg, 67000
FranceSite Not Available
Novartis Investigative Site
Strasbourg 2973783, 67000
FranceSite Not Available
Novartis Investigative Site
Bonn, 53105
GermanySite Not Available
Novartis Investigative Site
Bonn 2946447, 53105
GermanySite Not Available
Novartis Investigative Site
Dresden, 01307
GermanySite Not Available
Novartis Investigative Site
Dresden 2935022, 01307
GermanySite Not Available
Novartis Investigative Site
Freiburg, 79106
GermanySite Not Available
Novartis Investigative Site
Freiburg im Breisgau 2925177, 79106
GermanySite Not Available
Novartis Investigative Site
Wuerzburg, 97080
GermanySite Not Available
Novartis Investigative Site
Würzburg 2805615, 97080
GermanySite Not Available
Novartis Investigative Site
Athens, 115 27
GreeceSite Not Available
Novartis Investigative Site
Athens 264371, 115 27
GreeceSite Not Available
Novartis Investigative Site
Szekesfehervar, Fejer 8000
HungarySite Not Available
Novartis Investigative Site
Székesfehérvár 3044774, Fejér 3053028 8000
HungarySite Not Available
Novartis Investigative Site
Szeged, 6720
HungarySite Not Available
Novartis Investigative Site
Szeged 715429, 6720
HungarySite Not Available
Novartis Investigative Site
Haifa, 3104802
IsraelSite Not Available
Novartis Investigative Site
Haifa 294801, 3104802
IsraelSite Not Available
Novartis Investigative Site
Kfar Saba, 4428164
IsraelSite Not Available
Novartis Investigative Site
Kfar Saba 294514, 4428164
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan, 5265601
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan 293788, 5265601
IsraelSite Not Available
Novartis Investigative Site
Milan 6951411, MI 20132
ItalySite Not Available
Novartis Investigative Site
Milano, MI 20132
ItalySite Not Available
Novartis Investigative Site
Pisa, PI 56124
ItalySite Not Available
Novartis Investigative Site
Pisa 3170647, PI 56124
ItalySite Not Available
Novartis Investigative Site
Nagoya, Aichi 457 8510
JapanSite Not Available
Novartis Investigative Site
Nagoya 1856057, Aichi-ken 1865694 457 8510
JapanSite Not Available
Novartis Investigative Site
Sasebo, Nagasaki 857-1195
JapanSite Not Available
Novartis Investigative Site
Sasebo-city, Nagasaki 857-1165
JapanSite Not Available
Novartis Investigative Site
Sasebo 1852899, Nagasaki 1856156 857-1195
JapanSite Not Available
Novartis Investigative Site
Kurashiki, Okayama 710-0824
JapanSite Not Available
Novartis Investigative Site
Kurashiki 1858311, Okayama-ken 1854381 710-0824
JapanSite Not Available
Novartis Investigative Site
Chuo ku, Tokyo 104 8560
JapanSite Not Available
Novartis Investigative Site
Chuo Ku, Tokyo 1850144 104 8560
JapanSite Not Available
Novartis Investigative Site
Seoul, Seocho Gu 06591
Korea, Republic ofSite Not Available
Novartis Investigative Site
Rotterdam 2747891, South Holland 2743698 3015 GD
NetherlandsSite Not Available
Novartis Investigative Site
Rotterdam, Zuid Holland 3015 GD
NetherlandsSite Not Available
Novartis Investigative Site
Groningen, 9713 GZ
NetherlandsSite Not Available
Novartis Investigative Site
Groningen 2755251, 9713 GZ
NetherlandsSite Not Available
Novartis Investigative Site
Lisboa, 1649 035
PortugalSite Not Available
Novartis Investigative Site
Lisbon 2267057, 1050-034
PortugalSite Not Available
Novartis Investigative Site
Ponte de Lima, 4990 041
PortugalSite Not Available
Novartis Investigative Site
Ponte de Lima 2736041, 4990 041
PortugalSite Not Available
Novartis Investigative Site
Brasov, 500283
RomaniaSite Not Available
Novartis Investigative Site
Brasov 683844, 500283
RomaniaSite Not Available
Novartis Investigative Site
Cluj Napoca, 400006
RomaniaSite Not Available
Novartis Investigative Site
Cluj-Napoca 681290, 400006
RomaniaSite Not Available
Novartis Investigative Site
Kazan' 551487, 420097
RussiaSite Not Available
Novartis Investigative Site
Moscow 524901, 115522
RussiaSite Not Available
Novartis Investigative Site
Saint Petersburg 498817, 195257
RussiaSite Not Available
Novartis Investigative Site
Tomsk 1489425, 634009
RussiaSite Not Available
Novartis Investigative Site
Yekaterinburg 1486209, 620028
RussiaSite Not Available
Novartis Investigative Site
Ekaterinburg, 620028
Russian FederationSite Not Available
Novartis Investigative Site
Kazan, 420097
Russian FederationSite Not Available
Novartis Investigative Site
Moscow, 115522
Russian FederationSite Not Available
Novartis Investigative Site
St Petersburg, 195257
Russian FederationSite Not Available
Novartis Investigative Site
Tomsk, 634009
Russian FederationSite Not Available
Novartis Investigative Site
Seoul 1835848, Seocho Gu 06591
South KoreaSite Not Available
Novartis Investigative Site
Stockholm, SE 113 65
SwedenSite Not Available
Novartis Investigative Site
Stockholm 2673730, SE 113 65
SwedenSite Not Available
Novartis Investigative Site
Ankara, 06500
TurkeySite Not Available
Novartis Investigative Site
Ankara 323786, 06500
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Birmingham, B15 2TH
United KingdomSite Not Available
Novartis Investigative Site
Birmingham 2655603, B15 2TH
United KingdomSite Not Available
Novartis Investigative Site
Doncaster, DN2 5LT
United KingdomSite Not Available
Novartis Investigative Site
Doncaster 2651123, DN2 5LT
United KingdomSite Not Available
Novartis Investigative Site
Manchester, M13 9WL
United KingdomSite Not Available
Novartis Investigative Site
Manchester 2643123, M13 9WL
United KingdomSite Not Available
North GA Rheumatology Group PC CAIN457FUS01
Duluth, Georgia 30096
United StatesSite Not Available
North GA Rheumatology Group, PC CAIN457FUS01
Duluth, Georgia 30096
United StatesSite Not Available
Novartis Investigative Site
Duluth, Georgia 30096
United StatesSite Not Available
North GA Rheumatology Group PC
Suwanee, Georgia 30024
United StatesSite Not Available
North GA Rheumatology Group PC
Suwanee 4225309, Georgia 4197000 30024
United StatesSite Not Available
Novartis Investigative Site
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Ochsner Health System
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Ochsner Health System Research Department
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Ochsner Health System
Baton Rouge 4315588, Louisiana 4331987 70809
United StatesSite Not Available
Novartis Investigative Site
Baltimore, Maryland 21224
United StatesSite Not Available
The John Hopkins Jerome L Greene
Baltimore, Maryland 21224
United StatesSite Not Available
The John Hopkins Jerome L Greene Sjogren
Baltimore, Maryland 21224
United StatesSite Not Available
The John Hopkins Jerome L Greene Sjogren
Baltimore 4347778, Maryland 4361885 21224
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02111
United StatesSite Not Available
Tufts School of Dental Medicine
Boston, Massachusetts 02111
United StatesSite Not Available
Tufts School of Dental Medicine
Boston 4930956, Massachusetts 6254926 02111
United StatesSite Not Available
Novartis Investigative Site
Mineola, New York 11501
United StatesSite Not Available
Winthrop University Hospital
Mineola, New York 11501
United StatesSite Not Available
Winthrop University Hospital
Mineola 5127134, New York 5128638 11501
United StatesSite Not Available
Novartis Investigative Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Perelman School of Medicine
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Novartis Investigative Site
Madison, Wisconsin 53792
United StatesSite Not Available
Uni Wisconsin School Med Pub Health
Madison, Wisconsin 53792
United StatesSite Not Available
Uni Wisconsin School Med Pub Health .
Madison, Wisconsin 53792
United StatesSite Not Available
Uni Wisconsin School Med Pub Health
Madison 5261457, Wisconsin 5279468 53792
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.