Clinical trial NCT03574545: Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
VAY736
Ianalumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Safety and tolerability as measured by the number of patients with adverse events
timeFrame: Week 0 - 112
measure: Pharmacokinetic comparability at steady state - AUCtau
timeFrame: Week 8 - 12
measure: Pharmacokinetic comparability at steady state - Cmax
timeFrame: Week 8 - 12
Secondary outcomes:
measure: Pharmacokinetic comparability after the first dose - AUCtau
timeFrame: Week 0 - 4
measure: Pharmacokinetic comparability after the first dose - Cmax
timeFrame: Week 0 - 4
measure: Pharmacokinetic comparability after the first dose - Tmax
timeFrame: Week 0 - 4
measure: Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf
timeFrame: Week 8 - 12
measure: Pharmacokinetic comparability after the last dose - Tmax
timeFrame: Week 8 - 12
measure: Pharmacokinetic comparability after the last dose - T1/2
timeFrame: Week 8 - 12
measure: Pharmacokinetic comparability at the end of each dosing interval - Ctrough
timeFrame: Week 0 - 12
measure: Pharmacodynamic effect as measured by B-cell level
timeFrame: Week 0 - 112
measure: Immunogenicity as measured by Anti-Drug Antibodies
timeFrame: Week 0 - 112
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Amman
country: Jordan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: