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Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03574545
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
Rheumatoid Arthritis Biological: VAY736 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : December 19, 2018
Estimated Primary Completion Date : December 14, 2021
Estimated Study Completion Date : December 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Reference VAY736 Drug Product
Powder for solution for injection / infusion
Biological: VAY736
Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)
Other Name: ianalumab

Experimental: Test VAY736 Drug Product
Solution for injection
Biological: VAY736
Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)
Other Name: ianalumab




Primary Outcome Measures :
  1. 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

  2. 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)

  3. Pharmacokinetic comparability at steady state - Cmax [ Time Frame: Week 8 - 12 ]
    Observed maximum serum concentration of ianalumab following drug administration (Cmax)


Secondary Outcome Measures :
  1. 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)

  2. Pharmacokinetic comparability after the first dose - Cmax [ Time Frame: Week 0 - 4 ]
    Observed maximum serum concentration of ianalumab following drug administration (Cmax)

  3. Pharmacokinetic comparability after the first dose - Tmax [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 8 - 12 ]
    Time to reach the maximum concentration after drug administration (Tmax)

  6. Pharmacokinetic comparability after the last dose - T1/2 [ Time Frame: Week 8 - 12 ]
    The terminal elimination half-life (T1/2)

  7. Pharmacokinetic comparability at the end of each dosing interval - Ctrough [ Time Frame: Week 0 - 12 ]
    Observed minimum serum ianalumab concentration following drug administration (Ctrough)

  8. Pharmacodynamic effect as measured by B-cell level [ Time Frame: Week 0 - 112 ]
    Circulating B cells (CD19+)

  9. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574545


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 10117
Jordan
Novartis Investigative Site Recruiting
Amman, Jordan, 11941
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03574545     History of Changes
Other Study ID Numbers: CVAY736A2101
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Rheumatoid Arthritis
VAY736
Ianalumab
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases