Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 18, 2024

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Reference VAY736 Drug Product
    • Powder for solution for injection / infusion
  • Experimental: Test VAY736 Drug Product
    • Solution for injection

Clinical Trial Outcome Measures

Primary Measures

  • Safety and tolerability as measured by the number of patients with adverse events
    • Time Frame: Week 0 – 112
    • The number of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of ianalumab
  • Pharmacokinetic comparability at steady state – AUCtau
    • Time Frame: Week 8 – 12
    • The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau)
  • Pharmacokinetic comparability at steady state – Cmax
    • Time Frame: Week 8 – 12
    • Observed maximum serum concentration of ianalumab following drug administration (Cmax)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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