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NCT03905525

PHASE2

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).

Official title: 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 Sjogren's Syndrome (TWINSS)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

273

Start Date

2019-10-01

Completion Date

2023-06-06

Last Updated

2026-05-18

Healthy Volunteers

Conditions

Sjögren Syndrome

Interventions

DRUG

CFZ533

Biological

OTHER

Placebo

liquid placebo for injections

Inclusion Criteria: Both cohorts must have met all the following criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Male or female patient \>= 18 years of age 3. Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2016) 4. Seropositive for anti-Ro/SSA antibodies 5. Stimulated whole salivary flow rate of \>= 0.1 mL/min 6. Able to communicate well with the Investigator to understand and comply with the requirements of the study Inclusion criteria specific for Cohort 1: 7. Screening ESSDAI value \>= 5 within the following 8 organ domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematologic and biologic * Patients with involvement of one or more of the remaining 4 domains are eligible but scores of these domains will not contribute to the assessment for eligibility for Cohort 1 * At selected sites participating in Cohort 2, patients who based on the above criterion 7, do not qualify for Cohort 1, should be further evaluated for Cohort 2 8. Screening ESSPRI score of \>= 5 Inclusion criteria specific for Cohort 2: 9. Screening ESSDAI value \< 5 within 8 domains scored for inclusion criterion #7 Cohort 1 10. Screening ESSPRI fatigue subscore \>= 5 or ESSPRI dryness subscore \>= 5 11. Hypergammaglobulinemia defined by IgG greater than upper limit of normal (ULN) or lymphocytopenia (less than lower limit of normal (LLN)) or hypocomplementemia (low C3, or low C4 - when considered due to disease activity and not due to genetic factors) 12. Score of \>= 30 on IDEEL symptom bother questionnaire at Screening Exclusion Criteria: 1. Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness 2. Use of other investigational drugs within 5 half-lives of enrollment or within 30 days whichever is longer, or longer if required by local regulations 3. Prior treatment with any of the following within 6 months prior to randomization: * B-cell depletors (e.g. rituximab, ianalumab) unless CD19+ B cell count have returned to ≥ 50 cells/µL * abatacept * anti-tumor necrosis factor alpha monoclonal anti-body * intravenous/subcutaneous Ig; plasmapheresis; i.v. or oral cyclophosphamide * i.v. or oral cyclosporine A * any other immunosuppressants unless explicitly allowed in criterion #5 4. Use of steroids (predniso(lo)ne or equivalent corticosteroid) at dose \> 10 mg/day 5. Use of steroids and synthetic DMARDS at inconsistent dose and within 3 months prior to randomization

Locations (71)

North GA Rheumatology Group PC

Suwanee, Georgia, United States

Indiana Univ School of Dentistry

Indianapolis, Indiana, United States

Ochsner Health System

Baton Rouge, Louisiana, United States

The John Hopkins Jerome L Greene Sjogren

Baltimore, Maryland, United States

Tufts School of Dental Medicine

Boston, Massachusetts, United States

Winthrop University Hospital

Mineola, New York, United States

Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Uni Wisconsin School Med Pub Health

Madison, Wisconsin, United States

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Nedlands, Western Australia, Australia

Novartis Investigative Site

Graz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Vitória, Espírito Santo, Brazil

Novartis Investigative Site

Juiz de Fora, Minas Gerais, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Rimouski, Quebec, Canada

Novartis Investigative Site

Trois-Rivières, Quebec, Canada

Novartis Investigative Site

Valdivia, Los Ríos Region, Chile

Novartis Investigative Site

Santiago, RM, Chile

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Novartis Investigative Site

Concepción, Chile

Novartis Investigative Site

Medellín, Antioquia, Colombia

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Brest, France

Novartis Investigative Site

Le Kremlin-Bicêtre, France

Novartis Investigative Site

Lille, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Strasbourg, France

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Novartis Investigative Site

Würzburg, Bavaria, Germany

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Bonn, Germany

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Székesfehérvár, Fejér, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Szeged, Hungary

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Kfar Saba, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Pisa, PI, Italy

Novartis Investigative Site

Udine, UD, Italy

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Sasebo, Nagasaki, Japan

Novartis Investigative Site

Kurashiki, Okayama-ken, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Novartis Investigative Site

Rotterdam, South Holland, Netherlands

Novartis Investigative Site

Groningen, Netherlands

Novartis Investigative Site

Almada, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Ponte de Lima, Portugal

Novartis Investigative Site

Brasov, Romania

Novartis Investigative Site

Cluj-Napoca, Romania

Novartis Investigative Site

Kazan', Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Orenburg, Russia

Novartis Investigative Site

Saint Petersburg, Russia

Novartis Investigative Site

Tomsk, Russia

Novartis Investigative Site

Yekaterinburg, Russia

Novartis Investigative Site

Seoul, Seocho Gu, South Korea

Novartis Investigative Site

Stockholm, SE, Sweden

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Birmingham, United Kingdom

Novartis Investigative Site

Doncaster, United Kingdom

Novartis Investigative Site

Manchester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)