PD of VAY736 in Patients With Primary Sjögren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 11 October 2021
• Main ID: NCT02149420
• Date of registration: 09/09/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: PD of VAY736 in Patients With Primary Sjögren's Syndrome CVAY736X2201
• Scientific title: A Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's Syndrome
• Date of first enrolment: May 23, 2014
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02149420
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France, Germany, Netherlands, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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-a 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjögren's Syndrome

Intervention(s)

Drug: Placebo

Drug: VAY736

Primary Outcome(s)

Overall Incidence of Adverse Events [Time Frame: Baseline to Week 24]

Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) [Time Frame: Baseline, week 12]

Secondary Outcome(s)

VAY736 Serum Concentration - AUClast [Time Frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.]

Change in Short Form (36) Health Survey (SF-36) [Time Frame: Baseline, week 12]

Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI) [Time Frame: Baseline, week 12]

VAY736 Serum Concentration - T1/2 [Time Frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.]

VAY736 Serum Concentration - Tmax [Time Frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.]

VAY736 Serum Concentration - Vz [Time Frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.]

Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS) [Time Frame: Baseline, week 12]

VAY736 Serum Concentration - Cmax [Time Frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.]

VAY736 Serum Concentration - AUCinf [Time Frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.]

VAY736 Serum Concentration - CL [Time Frame: 0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.]

Change in Multidimensional Fatigue Inventory (MFI) [Time Frame: Baseline, week 12]

Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS) [Time Frame: Baseline, week 12]

Secondary ID(s)

2013-000250-22

CVAY736X2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02149420