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

Last updated: October 8, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

CFZ533 (iscalimab)

CFZ533 Placebo

Iscalimab

Clinical Study ID

NCT04541589
CCFZ533B2201E1
2020-001942-20
  • Ages 18-99
  • 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:

  1. 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.

  2. 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).

  3. In the judgment of the Investigator, participants had to be expected to clinicallybenefit from continued iscalimab therapy.

Exclusion

Exclusion Criteria:

  1. 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

  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 was 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 were using highly effective methods ofcontraception during dosing and for 14 weeks after stopping the investigationaldrug.

  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): 4
Primary Treatment: CFZ533 (iscalimab)
Phase: 2
Study Start date:
January 05, 2021
Estimated Completion Date:
August 19, 2024

Study Description

This study was a continuation of the TWINSS core study CCFZ533B2201 (NCT03905525) that offered continuation of treatment for participants who completed the core study and were deemed by the Investigator to clinically benefit from continued iscalimab therapy based upon response to therapy at the end of the treatment period of the core study. The extension study was a 48-week treatment study, with a safety follow-up period of 12 weeks, to provide additional safety and tolerability information for iscalimab.At Week 60 of the TWINSS core study, eligible participants had the option to enroll in the extension study.

Participants were classified as treatment responders or non-responder based on their European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI) and EULAR Sjögren's syndrome patient reported index (ESSPRI) scores from predefined time points in the core study. In the extension study, participants were reassigned to either iscalimab 600 mg or 300 mg subcutaneously via prefilled syringes (PFS) based on their responder status and the iscalimab doses that they received in the core study

All participants enrolled in the extension study received a weekly loading regimen at the start of the treatment period for the initial 3 weeks, followed by a subcutaneous maintenance regimen (600 or 300 mg subcutaneously every 2 weeks). Injections were performed at site or at home by site staff or participant/caregiver.

Study blinding for the extension study was maintained until final database lock of the core study, upon which the participants and Investigators were unblinded, making it an open-label study through Week 120 (end of study visit).

Connect with a study center

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    Ciudad Autonoma de Bs As, Buenos Aires 3435907 C1055AAF
    Argentina

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    CABA, 1426
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    Duluth, Georgia 30096
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    Baltimore 4347778, Maryland 4361885 21224
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    Boston, Massachusetts 02111
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  • Tufts School of Dental Medicine

    Boston, Massachusetts 02111
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    Boston 4930956, Massachusetts 6254926 02111
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    Mineola, New York 11501
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  • Winthrop University Hospital

    Mineola, New York 11501
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    Mineola 5127134, New York 5128638 11501
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    Philadelphia, Pennsylvania 19104
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  • Perelman School of Medicine

    Philadelphia, Pennsylvania 19104
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    Philadelphia 4560349, Pennsylvania 6254927 19104
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    Madison, Wisconsin 53792
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    Madison, Wisconsin 53792
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    Madison, Wisconsin 53792
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  • Uni Wisconsin School Med Pub Health

    Madison 5261457, Wisconsin 5279468 53792
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