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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sjögren Syndrome

In brief

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).

Key facts

Study ID

NCT03905525

Run by

Novartis Pharmaceuticals

People needed

273

Starts

2019-10-01

Expected to finish

2023-06-06

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Both cohorts must have met all the following criteria:
• Signed informed consent must be obtained prior to participation in the study
• Male or female patient >= 18 years of age
• Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2016)
• Seropositive for anti-Ro/SSA antibodies
• Stimulated whole salivary flow rate of >= 0.1 mL/min
• Able to communicate well with the Investigator to understand and comply with the requirements of the study
• Inclusion criteria specific for Cohort 1:
• 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
• Screening ESSPRI score of >= 5
• Inclusion criteria specific for Cohort 2:
• Screening ESSDAI value < 5 within 8 domains scored for inclusion criterion #7 Cohort 1
• Screening ESSPRI fatigue subscore >= 5 or ESSPRI dryness subscore >= 5
• 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)
• Score of >= 30 on IDEEL symptom bother questionnaire at Screening

You may not qualify if…

• Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness
• 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
• 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
• Use of steroids (predniso(lo)ne or equivalent corticosteroid) at dose > 10 mg/day
• Use of steroids and synthetic DMARDS at inconsistent dose and within 3 months prior to randomization

Where it is running

• 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
• North GA Rheumatology Group PC — Suwanee, Georgia, United States

Full record on ClinicalTrials.gov

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