Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: ianalumab

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Novartis Investigative Site
• Jordan
  • Amman, Jordan, 11941
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference VAY736 Drug Product; Powder for solution for injection / infusion	Biological: ianalumab; Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R); Other Names: VAY736
Experimental: Test VAY736 Drug Product; Solution for injection	Biological: ianalumab; Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R); Other Names: VAY736

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic comparability after the first dose - AUCtau	The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau)	Week 0 - 4
Pharmacokinetic comparability after the first dose - Cmax	Observed maximum serum concentration of ianalumab following drug administration (Cmax)	Week 0 - 4
Pharmacokinetic comparability after the first dose - Tmax	Time to reach the maximum concentration after drug administration (Tmax)	Week 0 - 4
Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf	The area under the serum ianalumab concentration-time curve from time zero to infinity (AUCinf)	Week 8 - 12
Pharmacokinetic comparability after the last dose - Tmax	Time to reach the maximum concentration after drug administration (Tmax)	Week 8 - 12
Pharmacokinetic comparability after the last dose - T1/2	The terminal elimination half-life (T1/2)	Week 8 - 12
Pharmacokinetic comparability at the end of each dosing interval - Ctrough	Observed minimum serum ianalumab concentration following drug administration (Ctrough)	Week 0 - 12
Pharmacodynamic effect as measured by B-cell level	Circulating B cells (CD19+)	Week 0 - 112
Immunogenicity as measured by Anti-Drug Antibodies	Anti-ianalumab antibodies (ADA); incidence of ADA positive patients and correlation with AEs, PK and clinical outcomes	Week 0 - 112

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Estimated): July 18, 2024
• Study Completion (Estimated): July 18, 2024

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; VAY736; Ianalumab
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: CVAY736A2101; 2018-001173-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No