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Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
CompletedPhase 2
Sponsor: Novartis Pharmaceuticals
Conditions: Sjögren Syndrome
Interventions: CFZ533, Placebo
Countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia
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).
Eligibility overview
Sex: ALL
Age: 18 Years to 100 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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)
- Suwanee, Georgia, United States
- Indianapolis, Indiana, United States
- Baton Rouge, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Mineola, New York, United States
- Philadelphia, Pennsylvania, United States
- Madison, Wisconsin, United States
- Buenos Aires, Argentina
- CABA, Argentina
- Nedlands, Western Australia, Australia
- Graz, Austria
- Vienna, Austria
- Vitória, Espírito Santo, Brazil
- Juiz de Fora, Minas Gerais, Brazil
- São Paulo, São Paulo, Brazil
- Toronto, Ontario, Canada
- Rimouski, Quebec, Canada
- Trois-Rivières, Quebec, Canada
- Valdivia, Los Ríos Region, Chile
- Santiago, RM, Chile
- Santiago, Santiago Metropolitan, Chile
- Santiago, Santiago Metropolitan, Chile
- Concepción, Chile
- Medellín, Antioquia, Colombia
- Barranquilla, Atlántico, Colombia
- Cali, Valle del Cauca Department, Colombia
- Brest, France
- Le Kremlin-Bicêtre, France
- Lille, France
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