Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

NCT ID: NCT03574545

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2024-07-18

Brief Summary

This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reference VAY736 Drug Product

Powder for solution for injection / infusion

Group Type: ACTIVE_COMPARATOR

ianalumab

Intervention Type: BIOLOGICAL

Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)

Test VAY736 Drug Product

Solution for injection

Group Type: EXPERIMENTAL

ianalumab

Intervention Type: BIOLOGICAL

Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)

Interventions

ianalumab

Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)

Intervention Type: BIOLOGICAL

Other Intervention Names

VAY736

Eligibility Criteria

Inclusion Criteria

• Fulfill 2010 ACR/EULAR criteria for RA Aletaha et al 2010 at Screening
• Active disease defined as ≥ 2 swollen joints (of 58 evaluable joints) and ≥ 2 tender joints (of 60 evaluable joints) despite stable MTX ≤ 25 mg/week and/or hydroxychloroquine ≤ 400 mg/day treatment for at least 2 months prior to randomization

Exclusion Criteria

• Prior or previous use of (specific dosages and intervals prior to study start may apply): other investigational drugs, B-cell depleting therapy (e.g. rituximab), monoclonal antibodies (mAb), i.v. / s.c. Ig, thymoglobulin, i.v. or oral cyclophosphamide, oral cyclosporine, soluble cytokine receptors, azathioprine.
• Currently receiving prednisone >10 mg/day (or equivalent oral glucocorticoid) or dose adjustment within 2 weeks prior to randomization
• Active viral, bacterial or other infections requiring systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
• Receipt of live/attenuated vaccine within a 2-month period before randomization
• Pregnant or nursing (lactating) women
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from screening and for 4 months after stopping of investigational drug

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Amman, , Jordan

Countries

Germany; Jordan

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18328

Link to results from the Novartis Clinical Trial Results Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2687

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

2018-001173-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CVAY736A2101

Identifier Type: -

Identifier Source: org_study_id