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

Novartis

Status and phase: Completed; Phase 2

Conditions: Primary Sjögren's Syndrome

Treatments: Drug: CFZ533 active - Cohort 2; Drug: CFZ533 active -Cohort 3; Drug: CFZ533 active - Cohort 1; Drug: CFZ533 placebo - Cohort 2; Drug: CFZ533 placebo- Cohort 1; Drug: CFZ533 active - Cohort 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291029

CCFZ533X2203

Details and patient eligibility

About

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)

Enrollment: 69 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 6 patient groups, including a placebo group

CFZ533 active- Cohort 2

Experimental group

Description:

multiple doses of CFZ533 intravenous infusion

Treatment:

Drug: CFZ533 active - Cohort 2

CFZ533 placebo- Cohort 2

Placebo Comparator group

Description:

multiple doses of placebo intravenous infusion

Treatment:

Drug: CFZ533 placebo - Cohort 2

CFZ533 active - Cohort 1

Experimental group

Description:

multiple doses of CFZ533 s.c. injection

Treatment:

Drug: CFZ533 active - Cohort 1

CFZ533 placebo - Cohort 1

Placebo Comparator group

Description:

multiple doses of placebo s.c. injection

Treatment:

Drug: CFZ533 placebo- Cohort 1

CFZ533 Treatment Arm 1 - Cohort 3

Experimental group

Description:

multiple doses of CFZ533 s.c. injection

Treatment:

Drug: CFZ533 active -Cohort 3

CFZ533 Treatment Arm 2 - Cohort 3

Experimental group

Description:

Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection

Treatment:

Drug: CFZ533 active - Cohort 3