Phase 2 N=69 Randomized Triple-blind Treatment

Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

Primary Sjögren's Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02291029 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Aug 2019

Primary outcome: Primary: Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) — 12.0; 11.8; 10.6; 11.0 units on a scale — p=0.397

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CFZ533 active - Cohort 1 (Drug); CFZ533 placebo- Cohort 1 (Drug); CFZ533 active - Cohort 2 (Drug); CFZ533 placebo - Cohort 2 (Drug); CFZ533 active -Cohort 3 (Drug); CFZ533 active - Cohort 3 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)	12.0; 11.8; 10.6; 11.0; 12.7; 10.4	0.397
SECONDARY Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)	6.75; 7.00; 6.71; 7.18; 7.00; 6.00	0.205
SECONDARY Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)	57.9; 57.8; 51.9; 47.9; 50.4; 47.1	0.161
SECONDARY Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)	47.13; 73.00; 58.43; 54.91; 63.69; 52.08	0.456
SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score	42.218; 31.215; 38.163; 38.819; 40.374; 36.123	0.172
SECONDARY Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score	46.838; 43.118; 37.071; 39.512; 48.076; 43.660	0.986
SECONDARY Change From Baseline in Multidimensional Fatigue Inventory (MFI)	54.1; 78.0; 70.0; 66.2; 53.5; 69.8	0.807

Summary

This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)

Eligibility Criteria

Inclusion Criteria

Diagnosis of primary Sjögren's syndrome
ESSDAI score ≥ 6

Exclusion Criteria

Secondary Sjögren's syndrome
Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimunab, other immunosuppressives.
At significant risk for thromboembolic event
Clinically significant systemic infection
Significant elevated risk for infection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02291029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.