Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjögren's Syndrome

A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjögren's Syndrome (TWINSS)

ClinicalTrials.gov Identifier: NCT03905525

Novartis Reference Number: CCFZ533B2201

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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 safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

Condition 
Sjögren Syndrome
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
260 participants
Start date 
Oct 01, 2019
Completion date 
Jun 21, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
CFZ533
Biological
Other
Placebo
liquid placebo for injections

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Male or female patient ≥ 18 years of age
Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2017)
Seropositive for anti-Ro/SSA antibodies
Stimulated whole salivary flow rate of ≥ 0.1 mL/min

Inclusion criteria specific for Cohort 1:

ESSDAI ≥ 5 within the 8 predefined organ domains
ESSPRI score of ≥5

Inclusion criteria specific for Cohort 2:

ESSDAI < 5 within 8 domains scored for inclusion criterion for Cohort 1
ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5

Exclusion Criteria:

Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness
Use of other investigational drugs
Prior use of B cell depleting therapies, abatacept or any other immunosuppressants unless specifically allowe be the protocol.
Use of steroids at dose >10 mg/day.
Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis or Meibomian gland disease (this criterion applies only to patients considered for Cohort 2)
Active viral, bacterial or other infections requiring systemic treatment
Receipt of live/attenuated vaccine within a 2-month period prior to randomization.
Chronic infection with hepatitis B (HBV) or hepatitis C (HCV).
Evidence of active tuberculosis (TB) infection.

Study Locations

United States
Novartis Investigative Site
Recruiting
Duluth, 30096
Georgia
United States
Novartis Investigative Site
Recruiting
Indianapolis, 46202
Indiana
United States
Novartis Investigative Site
Recruiting
Baltimore, 21224
Maryland
United States
Australia
Novartis Investigative Site
Recruiting
Nedlands, 6009
Western Australia
Australia
Austria
Novartis Investigative Site
Recruiting
Graz, 8036
-
Austria
Novartis Investigative Site
Recruiting
Wien, 1090
-
Austria
Brazil
Novartis Investigative Site
Recruiting
Vitoria, 29055 450
ES
Brazil
Novartis Investigative Site
Recruiting
Curitiba, 80440-080
PR
Brazil
Novartis Investigative Site
Recruiting
São Paulo, 01244-030
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 04039032
-
Brazil
Canada
Novartis Investigative Site
Recruiting
Trois Rivieres, G8Z 1Y2
Quebec
Canada
France
Novartis Investigative Site
Recruiting
Brest, 29200
-
France
Novartis Investigative Site
Recruiting
Le Kremlin Bicetre, 94275
-
France
Novartis Investigative Site
Recruiting
Lille, 59000
-
France
Novartis Investigative Site
Recruiting
Paris Cedex 14, 75679
-
France
Novartis Investigative Site
Recruiting
Strasbourg, 67000
-
France
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
-
Greece
Hungary
Novartis Investigative Site
Recruiting
Szekesfehervar, 8000
Fejer
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1023
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
-
Hungary
Israel
Novartis Investigative Site
Recruiting
Haifa, 3339419
-
Israel
Novartis Investigative Site
Recruiting
Kfar Saba, 44281
-
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 52621
-
Israel
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
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
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Gwangju, 61469
-
Korea, Republic of
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CE
-
Netherlands
Portugal
Novartis Investigative Site
Recruiting
Almada, 2801 951
-
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
Orenburg, 460000
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 190068
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 195257
-
Russian Federation
Slovenia
Novartis Investigative Site
Recruiting
Ljubljana, SI-1107
-
Slovenia
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06560
-
Turkey
Novartis Investigative Site
Recruiting
Zuhuratbaba / Istanbul, 34147
-
Turkey
United Kingdom
Novartis Investigative Site
Recruiting
Doncaster, DN2 5LT
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]