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

Last updated: September 18, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

CFZ533 (iscalimab)

CFZ533 Placebo

Clinical Study ID

NCT04541589
CCFZ533B2201E1
2020-001942-20
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

  1. 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

  2. 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)

  3. 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.

  1. 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

  1. Use of other investigational drugs other than iscalimab during the core study

  2. 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

  3. 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

  4. 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.

  5. 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

Total Participants: 206
Treatment Group(s): 2
Primary Treatment: CFZ533 (iscalimab)
Phase: 2
Study Start date:
January 05, 2021
Estimated Completion Date:
August 19, 2024

Study Description

This Extension study is a 48-week treatment study, with a safety follow-up period of 12 weeks. This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who 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.

Study treatment will be administered as bi-weekly subcutaneous injections (Q2W s.c.) via prefilled syringes (PFS).

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires C1055AAF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Caba, 1426
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Novartis Investigative Site

    Graz, 8036
    Austria

    Site Not Available

  • Novartis Investigative Site

    Wien, 1090
    Austria

    Site Not Available

  • Novartis Investigative Site

    Vitoria, ES 29055 450
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Juiz de Fora, MG 36010 570
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 01244-030
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, SP 01244-030
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Rimouski, Quebec G5L 5T1
    Canada

    Site Not Available

  • Novartis Investigative Site

    Trois Rivieres, Quebec G9A 3Y2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Valdivia, Los Rios 5110683
    Chile

    Site Not Available

  • Novartis Investigative Site

    Santiago, RM 7500588
    Chile

    Site Not Available

  • Novartis Investigative Site

    Medellin, Antioquia 050001
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Barranquilla, Atlantico 080002
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Brest, 29200
    France

    Site Not Available

  • Novartis Investigative Site

    Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • Novartis Investigative Site

    Lille, 59000
    France

    Site Not Available

  • Novartis Investigative Site

    Strasbourg, 67000
    France

    Site Not Available

  • Novartis Investigative Site

    Bonn, 53105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Freiburg, 79106
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Novartis Investigative Site

    Athens, 115 27
    Greece

    Site Not Available

  • Novartis Investigative Site

    Szekesfehervar, Fejer 8000
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged, 6720
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Haifa, 3339419
    Israel

    Site Not Available

  • Novartis Investigative Site

    Kfar Saba, 44281
    Israel

    Site Not Available

  • Novartis Investigative Site

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20132
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pisa, PI 56124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi 457 8510
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sasebo-city, Nagasaki 857-1165
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kurashiki, Okayama 710-8522
    Japan

    Site Not Available

  • Novartis Investigative Site

    Chuo ku, Tokyo 104 8560
    Japan

    Site Not Available

  • Novartis Investigative Site

    Seoul, Seocho Gu 06591
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Rotterdam, Zuid Holland 3015 GD
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Lisboa, 1050-034
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Ponte de Lima, 4990 041
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Brasov, 500283
    Romania

    Site Not Available

  • Novartis Investigative Site

    Cluj Napoca, 400006
    Romania

    Site Not Available

  • Novartis Investigative Site

    Ekaterinburg, 620028
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Kazan, 420097
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Moscow, 115522
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    St Petersburg, 195257
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Tomsk, 634009
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Stockholm, SE 113 65
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Ankara, 06500
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Doncaster, DN2 5LT
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • North GA Rheumatology Group PC CAIN457FUS01

    Duluth, Georgia 30096
    United States

    Site Not Available

  • North GA Rheumatology Group, PC CAIN457FUS01

    Duluth, Georgia 30096
    United States

    Site Not Available

  • Novartis Investigative Site

    Duluth, Georgia 30096
    United States

    Site Not Available

  • Novartis Investigative Site

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Ochsner Health System Research Department

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Novartis Investigative Site

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • The John Hopkins Jerome L Greene

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • The John Hopkins Jerome L Greene Sjogren

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Tufts School of Dental Medicine

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Novartis Investigative Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Perelman School of Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Novartis Investigative Site

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Uni Wisconsin School Med Pub Health .

    Madison, Wisconsin 53792
    United States

    Site Not Available

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