Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome

A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome

ClinicalTrials.gov Identifier: NCT04541589

Novartis Reference Number: CCFZ533B2201E1

Last Update: Dec 03, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201(NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab at two dose level.

Condition 
Sjögren's Syndrome
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Jan 05, 2021
Completion date 
Apr 22, 2024
Gender 
All
Age(s)
18 Years - 90 Years (Adult, Older Adult)

Interventions

Drug
CFZ533 (iscalimab)
Biological
Other
CFZ533 Placebo
Matching placebo
Drug
CFZ533 (iscalimab)
Biological
Other
CFZ533 Placebo
Matching placebo
Drug
CFZ533 (iscalimab)
Biological
Other
CFZ533 Placebo
Matching placebo

Eligibility Criteria

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 and the follow-up period up to Week 60
Signed informed consent must be obtained prior to participation in the Extension study (i.e. before commencement of the Week 60 assessments of the core study)
In the judgement of the Investigator, participants must be expected to clinically benefit from continued iscalimab therapy

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 disease constitutes the principle illness, specifically:

Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSDAI domains
Active rheumatoid arthritis (RA) that impedes on the ability to score the ESSDAI 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 of this 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 systemic treatment at the time of enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception 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 study at Weeks 0 and 4 or Weeks 40 and 48.

Study Locations

Austria
Novartis Investigative Site
Recruiting
Graz, 8036
-
Austria
Novartis Investigative Site
Recruiting
Graz, 8036
-
Austria
Novartis Investigative Site
Recruiting
Graz, 8036
-
Austria
France
Novartis Investigative Site
Recruiting
Le Kremlin Bicetre, 94275
-
France
Novartis Investigative Site
Recruiting
Le Kremlin Bicetre, 94275
-
France
Novartis Investigative Site
Recruiting
Le Kremlin Bicetre, 94275
-
France
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
-
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
-
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
-
Greece
Hungary
Novartis Investigative Site
Recruiting
Szekesfehervar, 8000
Fejer
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
-
Hungary
Novartis Investigative Site
Recruiting
Szekesfehervar, 8000
Fejer
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
-
Hungary
Novartis Investigative Site
Recruiting
Szekesfehervar, 8000
Fejer
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
-
Hungary
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 52621
-
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 52621
-
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 52621
-
Israel
Japan
Novartis Investigative Site
Recruiting
Nagoya, 457 8510
Aichi
Japan
Novartis Investigative Site
Recruiting
Sasebo-city, 857-1165
Nagasaki
Japan
Novartis Investigative Site
Recruiting
Kurashiki, 710-8522
Okayama
Japan
Novartis Investigative Site
Recruiting
Nagoya, 457 8510
Aichi
Japan
Novartis Investigative Site
Recruiting
Sasebo-city, 857-1165
Nagasaki
Japan
Novartis Investigative Site
Recruiting
Kurashiki, 710-8522
Okayama
Japan
Novartis Investigative Site
Recruiting
Nagoya, 457 8510
Aichi
Japan
Novartis Investigative Site
Recruiting
Sasebo-city, 857-1165
Nagasaki
Japan
Novartis Investigative Site
Recruiting
Kurashiki, 710-8522
Okayama
Japan
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CE
-
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CE
-
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CE
-
Netherlands
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1050-034
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1649-035
-
Portugal
Novartis Investigative Site
Recruiting
Ponte de Lima, 4990 041
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1050-034
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1649-035
-
Portugal
Novartis Investigative Site
Recruiting
Ponte de Lima, 4990 041
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1050-034
-
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1649-035
-
Portugal
Novartis Investigative Site
Recruiting
Ponte de Lima, 4990 041
-
Portugal
Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg, 620028
-
Russian Federation
Novartis Investigative Site
Recruiting
Kazan, 420097
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 195257
-
Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg, 620028
-
Russian Federation
Novartis Investigative Site
Recruiting
Kazan, 420097
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 195257
-
Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg, 620028
-
Russian Federation
Novartis Investigative Site
Recruiting
Kazan, 420097
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 195257
-
Russian Federation
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06560
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06560
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06560
-
Turkey

Contacts

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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Call 1-888-669-6682 or email [email protected]