Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Sjogren's Syndrome
Treatment
CFZ533 (iscalimab)
CFZ533 Placebo
Clinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
Participants must have participated in the TWINSS core study, CCFZ533B2201 (NCT03905525), and must have completed the entire treatment period up to Week 48 andthe follow-up period up to Week 60
Signed informed consent must be obtained prior to participation in the Extensionstudy (i.e. before commencement of the Week 60 assessments of the core study)
In the judgement of the Investigator, participants must be expected to clinicallybenefit from continued iscalimab therapy
Exclusion
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study.
- Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic diseaseconstitutes the principle illness, specifically:
Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNApositivity and renal involvement, or other organ involvement that impedes onability to score ESSDAI domains
Active rheumatoid arthritis (RA) that impedes 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 is active and requires 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 is 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 are using highly effective methods ofcontraception during dosing and for 14 weeks after stopping of investigational drug.
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 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
Graz, 8036
AustriaSite Not Available
Novartis Investigative Site
Wien, 1090
AustriaSite Not Available
Novartis Investigative Site
Vitoria, ES 29055 450
BrazilSite Not Available
Novartis Investigative Site
Juiz de Fora, MG 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
Toronto, Ontario 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
Valdivia, Los Rios 5110683
ChileSite Not Available
Novartis Investigative Site
Santiago, RM 7500588
ChileSite Not Available
Novartis Investigative Site
Medellin, Antioquia 050001
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla, Atlantico 080002
ColombiaSite Not Available
Novartis Investigative Site
Brest, 29200
FranceSite Not Available
Novartis Investigative Site
Le Kremlin Bicetre, 94275
FranceSite Not Available
Novartis Investigative Site
Lille, 59000
FranceSite Not Available
Novartis Investigative Site
Strasbourg, 67000
FranceSite Not Available
Novartis Investigative Site
Bonn, 53105
GermanySite Not Available
Novartis Investigative Site
Dresden, 01307
GermanySite Not Available
Novartis Investigative Site
Freiburg, 79106
GermanySite Not Available
Novartis Investigative Site
Wuerzburg, 97080
GermanySite Not Available
Novartis Investigative Site
Athens, 115 27
GreeceSite Not Available
Novartis Investigative Site
Szekesfehervar, Fejer 8000
HungarySite Not Available
Novartis Investigative Site
Szeged, 6720
HungarySite Not Available
Novartis Investigative Site
Haifa, 3339419
IsraelSite Not Available
Novartis Investigative Site
Kfar Saba, 44281
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan, 52621
IsraelSite Not Available
Novartis Investigative Site
Milano, MI 20132
ItalySite Not Available
Novartis Investigative Site
Pisa, PI 56124
ItalySite Not Available
Novartis Investigative Site
Nagoya, Aichi 457 8510
JapanSite Not Available
Novartis Investigative Site
Sasebo-city, Nagasaki 857-1165
JapanSite Not Available
Novartis Investigative Site
Kurashiki, Okayama 710-8522
JapanSite Not Available
Novartis Investigative Site
Chuo ku, Tokyo 104 8560
JapanSite Not Available
Novartis Investigative Site
Seoul, Seocho Gu 06591
Korea, Republic ofSite 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
Lisboa, 1050-034
PortugalSite Not Available
Novartis Investigative Site
Ponte de Lima, 4990 041
PortugalSite Not Available
Novartis Investigative Site
Brasov, 500283
RomaniaSite Not Available
Novartis Investigative Site
Cluj Napoca, 400006
RomaniaSite 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
Stockholm, SE 113 65
SwedenSite Not Available
Novartis Investigative Site
Ankara, 06500
TurkeySite Not Available
Novartis Investigative Site
Birmingham, B15 2TH
United KingdomSite Not Available
Novartis Investigative Site
Doncaster, DN2 5LT
United KingdomSite Not Available
Novartis Investigative Site
Manchester, 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
Novartis Investigative Site
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Ochsner Health System Research Department
Baton Rouge, Louisiana 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
Novartis Investigative Site
Boston, Massachusetts 02111
United StatesSite Not Available
Tufts School of Dental Medicine
Boston, Massachusetts 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
Novartis Investigative Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Perelman School of Medicine
Philadelphia, Pennsylvania 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
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