PD of VAY736 in Patients With Primary Sjögren's Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-23

Study Completion Date

2018-02-07

Brief Summary

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This study was designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS patients

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Detailed Description

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Patients were enrolled in 2 sequential cohorts:

Cohort 1: 6 patients received 3 mg/kg or Placebo (2:1 ratio) Cohort 2: 21 patients received 10 mg/kg, 3 mg/kg or Placebo (6:1:3 ratio)

At week 24 the blind was broken to assess continuation in the trial:

* If a patient received VAY736 and their B cell recovery was demonstrated at Week 24, then patients completed the trial.
* If a patient received VAY736 and their B cell recovery was NOT demonstrated at Week 24, then patients were followed up until B cell recovery was demonstrated
* If a patient received placebo, they were offered the option of receiving open-label VAY736 (10 mg/kg) in a separate treatment arm.

Conditions

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Primary Sjögren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Treatment was unblinded at an individual patient level at Week 24 to determine their progress in the study (follow-up, open-label VAY736 or End of Study Visit).

Study Groups

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VAY736 3 mg/kg

single dose iv of VAY736 at a dose of 3mg/kg

Group Type EXPERIMENTAL

VAY736

Intervention Type DRUG

VAY736 10 mg/kg

single dose iv of VAY736 at a dose of 10mg/kg

Group Type EXPERIMENTAL

VAY736

Intervention Type DRUG

Placebo

single dose iv of Placebo. At Week 24 patients were offered to receive open label VAY736 10 mg/kg.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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VAY736

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fulfilled revised European US consensus criteria for pSS
* ESSDAI value ≥ 6
* Elevated serum titers at screening of ANA (≥ 1:160)
* Seropositive at screening for anti-SSA and/or anti-SSB antibodies
* Stimulated whole salivary flow rate at screening of \> 0 mL/min

Exclusion Criteria

\- Prior or previous use of (specific dosages and intervals prior to study start may apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig (abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause dry mouth.

Hydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to randomization is allowed

* Active or recent history of clinically significant infection
* Vaccination within 2 month prior to study
* History of primary or secondary immunodeficiency

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No