Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03574545
• Other study ID #: CVAY736A2101
• Secondary ID: 2018-001173-24
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 19, 2018
• Est. completion date: July 18, 2024

Study information

• Verified date: January 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: July 18, 2024
• Est. primary completion date: July 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Jordan	Novartis Investigative Site	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Pharmacokinetic comparability at steady state - Cmax	Observed maximum serum concentration of ianalumab following drug administration (Cmax)	Week 8 - 12
Secondary	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
Secondary	Pharmacokinetic comparability after the first dose - Cmax	Observed maximum serum concentration of ianalumab following drug administration (Cmax)	Week 0 - 4
Secondary	Pharmacokinetic comparability after the first dose - Tmax	Time to reach the maximum concentration after drug administration (Tmax)	Week 0 - 4
Secondary	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
Secondary	Pharmacokinetic comparability after the last dose - Tmax	Time to reach the maximum concentration after drug administration (Tmax)	Week 8 - 12
Secondary	Pharmacokinetic comparability after the last dose - T1/2	The terminal elimination half-life (T1/2)	Week 8 - 12
Secondary	Pharmacokinetic comparability at the end of each dosing interval - Ctrough	Observed minimum serum ianalumab concentration following drug administration (Ctrough)	Week 0 - 12
Secondary	Pharmacodynamic effect as measured by B-cell level	Circulating B cells (CD19+)	Week 0 - 112
Secondary	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