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Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03574545
Collaborator
(none)
48
Enrollment
2
Locations
2
Arms
69.5
Anticipated Duration (Months)
24
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: ianalumab
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 19, 2018
Anticipated Primary Completion Date :
Oct 4, 2023
Anticipated Study Completion Date :
Oct 2, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability as measured by the number of patients with adverse events [Week 0 - 112]

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

    2. Pharmacokinetic comparability at steady state - AUCtau [Week 8 - 12]

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

    3. Pharmacokinetic comparability at steady state - Cmax [Week 8 - 12]

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

    Secondary Outcome Measures

    1. Pharmacokinetic comparability after the first dose - AUCtau [Week 0 - 4]

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

    2. Pharmacokinetic comparability after the first dose - Cmax [Week 0 - 4]

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

    3. Pharmacokinetic comparability after the first dose - Tmax [Week 0 - 4]

      Time to reach the maximum concentration after drug administration (Tmax)

    4. Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf [Week 8 - 12]

      The area under the serum ianalumab concentration-time curve from time zero to infinity (AUCinf)

    5. Pharmacokinetic comparability after the last dose - Tmax [Week 8 - 12]

      Time to reach the maximum concentration after drug administration (Tmax)

    6. Pharmacokinetic comparability after the last dose - T1/2 [Week 8 - 12]

      The terminal elimination half-life (T1/2)

    7. Pharmacokinetic comparability at the end of each dosing interval - Ctrough [Week 0 - 12]

      Observed minimum serum ianalumab concentration following drug administration (Ctrough)

    8. Pharmacodynamic effect as measured by B-cell level [Week 0 - 112]

      Circulating B cells (CD19+)

    9. Immunogenicity as measured by Anti-Drug Antibodies [Week 0 - 112]

      Anti-ianalumab antibodies (ADA); incidence of ADA positive patients and correlation with AEs, PK and clinical outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Berlin Germany 10117
    2 Novartis Investigative Site Amman Jordan 11941

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03574545
    Other Study ID Numbers:
    • CVAY736A2101
    • 2018-001173-24
    First Posted:
    Jul 2, 2018
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Rheumatoid Arthritis
    VAY736
    Ianalumab
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Jun 10, 2022