Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome (TWINSS Extn)

April 22, 2024 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Caba, Argentina, 1426
        • Novartis Investigative Site
    • Buenos Aires
      • Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1055AAF
        • Novartis Investigative Site
  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Novartis Investigative Site
      • Wien, Austria, 1090
        • Novartis Investigative Site
  • Brazil
    • ES
      • Vitoria, ES, Brazil, 29055 450
        • Novartis Investigative Site
    • MG
      • Juiz de Fora, MG, Brazil, 36010 570
        • Novartis Investigative Site
    • SP
      • São Paulo, SP, Brazil, 01244-030
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Novartis Investigative Site
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Novartis Investigative Site
      • Trois Rivieres, Quebec, Canada, G8Z 1Y2
        • Novartis Investigative Site
  • Chile
      • Santiago, Chile, 7500710
        • Novartis Investigative Site
      • Santiago, Chile, 7500571
        • Novartis Investigative Site
    • Los Rios
      • Valdivia, Los Rios, Chile, 5110683
        • Novartis Investigative Site
    • RM
      • Santiago, RM, Chile, 7500588
        • Novartis Investigative Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050001
        • Novartis Investigative Site
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080002
        • Novartis Investigative Site
  • France
      • Brest, France, 29200
        • Novartis Investigative Site
      • Le Kremlin Bicetre, France, 94275
        • Novartis Investigative Site
      • Lille, France, 59000
        • Novartis Investigative Site
      • Strasbourg, France, 67000
        • Novartis Investigative Site
  • Germany
      • Bonn, Germany, 53105
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Wuerzburg, Germany, 97080
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 27
        • Novartis Investigative Site
  • Hungary
      • Szeged, Hungary, 6720
        • Novartis Investigative Site
    • Fejer
      • Szekesfehervar, Fejer, Hungary, 8000
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3339419
        • Novartis Investigative Site
      • Kfar Saba, Israel, 44281
        • Novartis Investigative Site
      • Ramat Gan, Israel, 52621
        • Novartis Investigative Site
  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 457 8510
        • Novartis Investigative Site
    • Nagasaki
      • Sasebo-city, Nagasaki, Japan, 857-1165
        • Novartis Investigative Site
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8522
        • Novartis Investigative Site
    • Tokyo
      • Chuo ku, Tokyo, Japan, 104-8560
        • Novartis Investigative Site
  • Korea, Republic of
    • Seocho Gu
      • Seoul, Seocho Gu, Korea, Republic of, 06591
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3015 CE
        • Novartis Investigative Site
  • Portugal
      • Lisboa, Portugal, 1050-034
        • Novartis Investigative Site
      • Lisboa, Portugal, 1649-035
        • Novartis Investigative Site
      • Ponte de Lima, Portugal, 4990 041
        • Novartis Investigative Site
  • Romania
      • Brasov, Romania, 500283
        • Novartis Investigative Site
      • Cluj Napoca, Romania, 400006
        • Novartis Investigative Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620028
        • Novartis Investigative Site
      • Kazan, Russian Federation, 420097
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115522
        • Novartis Investigative Site
      • St Petersburg, Russian Federation, 195257
        • Novartis Investigative Site
      • Tomsk, Russian Federation, 634009
        • Novartis Investigative Site
  • Sweden
    • SE
      • Stockholm, SE, Sweden, 113 65
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey, 06560
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Novartis Investigative Site
      • Doncaster, United Kingdom, DN2 5LT
        • Novartis Investigative Site
      • Manchester, United Kingdom, M13 9WL
        • Novartis Investigative Site
  • United States
    • Georgia
      • Duluth, Georgia, United States, 30096
        • North GA Rheumatology Group, PC CAIN457FUS01
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Health System Research Department
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • The John Hopkins Jerome L Greene
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts School of Dental Medicine
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman School of Medicine
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Uni Wisconsin School Med Pub Health .

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 and the follow-up period up to Week 60
  2. 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)
  3. 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.

  1. 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
  2. Use of other investigational drugs other than iscalimab during the core study
  3. 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
  4. 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
  5. 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.
  6. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Arm 1 - Iscalimab Dose 1
Drug: CFZ533 (iscalimab)
Biological
Other Names:
  • iscalimab
Active Comparator: Arm 2
Arm 2 - Iscalimab Dose 2 and Placebo
Drug: CFZ533 (iscalimab)
Biological
Other Names:
  • iscalimab
Other: CFZ533 Placebo
Matching placebo
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-emergent adverse events (TEAEs)
Time Frame: 60 weeks
Number and percentage of participants having any AE
60 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods
Time Frame: 60 weeks
To assess the pharmacokinetics (PK trough levels)
60 weeks
Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study
Time Frame: 60 weeks
To assess immunogenicity of iscalimab
60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2021

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCFZ533B2201E1
  • 2020-001942-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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