Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

NCT03574545 | Completed Phase 1

• 2 other identifiers: CVAY736A21012018-001173-24
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; VAY736; Ianalumab

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability as measured by the number of patients with adverse events

  The number of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of ianalumab

  Week 0 - 112

• Pharmacokinetic comparability at steady state - AUCtau

  The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau)

  Week 8 - 12

• Pharmacokinetic comparability at steady state - Cmax

  Observed maximum serum concentration of ianalumab following drug administration (Cmax)

  Week 8 - 12

Secondary Outcomes (9)

• Pharmacokinetic comparability after the first dose - AUCtau

  Week 0 - 4

• Pharmacokinetic comparability after the first dose - Cmax

  Week 0 - 4

• Pharmacokinetic comparability after the first dose - Tmax

  Week 0 - 4

• Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf

  Week 8 - 12

• Pharmacokinetic comparability after the last dose - Tmax

  Week 8 - 12

Study Arms (2)

Reference VAY736 Drug Product

ACTIVE COMPARATOR

Powder for solution for injection / infusion

Biological: ianalumab

Test VAY736 Drug Product

EXPERIMENTAL

Solution for injection

Biological: ianalumab

Interventions

ianalumab BIOLOGICAL

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

Also known as: VAY736

Reference VAY736 Drug Product; Test VAY736 Drug Product

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Amman, 11941, Jordan

Location

Related Links

• Link to results from the Novartis Clinical Trial Results Website
• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ianalumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: December 19, 2018
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); JO (1)