Rheumatoid ArthritisPhase 1NCT03574545
Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis
A Phase 1 study testing ianalumab in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ianalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Dec 2018to 18 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ianalumab
- Keywords
- Rheumatoid Arthritis, VAY736, Ianalumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ianalumabBiological
Also called VAY736
Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)
| Study group | Role | What they receive |
|---|---|---|
| Reference VAY736 Drug Product | Active comparator | Powder for solution for injection / infusion Receives: Biological: ianalumab |
| Test VAY736 Drug Product | Experimental | Solution for injection Receives: Biological: ianalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 0 - 112
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)
Measured: Week 8 - 12
Pharmacokinetic comparability at steady state - Cmax
Observed maximum serum concentration of ianalumab following drug administration (Cmax)
Measured: Week 8 - 12
Secondary outcomes (9)
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)
Measured: Week 0 - 4
Pharmacokinetic comparability after the first dose - Cmax
Observed maximum serum concentration of ianalumab following drug administration (Cmax)
Measured: Week 0 - 4
Pharmacokinetic comparability after the first dose - Tmax
Time to reach the maximum concentration after drug administration (Tmax)
Measured: Week 0 - 4
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)
Measured: Week 8 - 12
Pharmacokinetic comparability after the last dose - Tmax
Time to reach the maximum concentration after drug administration (Tmax)
Measured: Week 8 - 12
Pharmacokinetic comparability after the last dose - T1/2
The terminal elimination half-life (T1/2)
Measured: Week 8 - 12
Pharmacokinetic comparability at the end of each dosing interval - Ctrough
Observed minimum serum ianalumab concentration following drug administration (Ctrough)
Measured: Week 0 - 12
Pharmacodynamic effect as measured by B-cell level
Circulating B cells (CD19+)
Measured: Week 0 - 112
Immunogenicity as measured by Anti-Drug Antibodies
Anti-ianalumab antibodies (ADA); incidence of ADA positive patients and correlation with AEs, PK and clinical outcomes
Measured: Week 0 - 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start19 Dec 2018
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574545
- Sponsor's protocol ID
- CVAY736A2101
- Other IDs
- 2018-001173-24, 2018
- Status last verified
- Nov 2025
- First submitted
- 21 Jun 2018
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03574545
- Acronym / sponsor ID
- CVAY736A2101
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, VAY736, Ianalumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference VAY736 Drug Product | Active comparator | Biological: ianalumabPowder for solution for injection / infusion |
| Test VAY736 Drug Product | Experimental | Biological: ianalumabSolution for injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ianalumabAlso: VAY736Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R) | Biological | Reference VAY736 Drug Product, Test VAY736 Drug Product |
Primary outcome
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)
9 secondary outcomes
Pharmacokinetic comparability after the first dose - AUCtau
Time frame: Week 0 - 4
Pharmacokinetic comparability after the first dose - Cmax
Time frame: Week 0 - 4
Pharmacokinetic comparability after the first dose - Tmax
Time frame: Week 0 - 4
Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf
Time frame: Week 8 - 12
Pharmacokinetic comparability after the last dose - Tmax
Time frame: Week 8 - 12
Pharmacokinetic comparability after the last dose - T1/2
Time frame: Week 8 - 12
Pharmacokinetic comparability at the end of each dosing interval - Ctrough
Time frame: Week 0 - 12
Pharmacodynamic effect as measured by B-cell level
Time frame: Week 0 - 112
Immunogenicity as measured by Anti-Drug Antibodies
Time frame: Week 0 - 112
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Link to results from the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ianalumab in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as measured by the number of patients with adverse events (time frame: Week 0 - 112). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.