PD of VAY736 in Patients With Primary Sjögren's Syndrome

NCT02149420 | Completed Phase 2 Results

• 2 other identifiers: CVAY736X22012013-000250-22
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Sjögren's Syndrome

Keywords

primary Sjögren's syndrome, pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)

  The effect of VAY736 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.

  Baseline, week 12

• Overall Incidence of Adverse Events

  Number of subjects with Adverse Events during the double blind treatment period.

  Baseline to Week 24

Secondary Outcomes (12)

• Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)

  Baseline, week 12

• Change in Short Form (36) Health Survey (SF-36)

  Baseline, week 12

• Change in Multidimensional Fatigue Inventory (MFI)

  Baseline, week 12

• Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)

  Baseline, week 12

• Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)

  Baseline, week 12

Study Arms (3)

VAY736 3 mg/kg

EXPERIMENTAL

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

Drug: VAY736

VAY736 10 mg/kg

EXPERIMENTAL

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

Drug: VAY736

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VAY736 DRUG

VAY736 10 mg/kg; VAY736 3 mg/kg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Berlin, 10117, Germany

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Interventions

ianalumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: May 29, 2014
• Study Start: May 23, 2014
• Primary Completion: February 7, 2018
• Study Completion: February 7, 2018
• Last Updated: October 4, 2021
• Results First Posted: February 12, 2019

Record last verified: 2021-09

Locations

DE (1)