Sjögrens DiseasePhase 2NCT06293365
Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
A Phase 2 study testing VAY736 1ml PFS, VAY736 2 ml PFS and VAY736 2ml AI in people with Sjögrens Disease and Systemic Lupus Erythematosus, run by Novartis Pharmaceuticals at 37 sites in 8 countries.
Trial summary
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- What is being tested?
- VAY736 1ml PFS, VAY736 2 ml PFS and VAY736 2ml AI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 37 sitesin 8 countries
- Study dates
- 2 Jul 2024to 16 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained before any assessment is performed.
- Male and female patients aged 18 years to 70 years (inclusive).
- Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2 at screening.
- Diagnosed with RA, SjD and/or SLE as determined by the investigator.
- Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
- Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment.
- Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study.
Who cannot join
- Use of prohibited therapies.
- Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection.
- Plans for administration of live vaccines during the study period.
- Uncontrolled co-existing serious disease.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug.
- US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
United States17 sites
Pinnacle Research Group Llc
Anniston, Alabama, 36207
Ochsner Health System
Baton Rouge, Louisiana, 70809
Novel Research LLC
Bellaire, Texas, 77401
Altoona Center for Clin Res
Duncansville, Pennsylvania, 16635
Providence Medical Foundation
Fullerton, California, 92835
Ahmed Arif Medical Research Center
Grand Blanc, Michigan, 48439
Indiana Univ School of Dentistry
Indianapolis, Indiana, 46202
West Tennessee Research Institute
Jackson, Tennessee, 38305
Advanced Medical Research
La Palma, California, 90623
Parris and Associates Rheumatology
Lawrenceville, Georgia, 30044
Shelby Research LLC
Memphis, Tennessee, 38119
Southwest Rheum Rsrch LLC
Mesquite, Texas, 75150
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio, 44130
RAO Research LLC
Oklahoma City, Oklahoma, 73116
Uni of Texas Health Science Center
San Antonio, Texas, 78229
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382
Conquest Research
Winter Park, Florida, 32789
Argentina4 sites
Novartis Investigative Site
Buenos Aires, C1055AAF
Novartis Investigative Site
Buenos Aires, C1437FFC
Novartis Investigative Site
Quilmes, Buenos Aires, 1878
Novartis Investigative Site
San Miguel Tucuman, Tucumán Province, T4000DPK
Canada4 sites
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5
Novartis Investigative Site
Rimouski, Quebec, G5L 5T1
Novartis Investigative Site
Toronto, Ontario, M5T 2S8
Novartis Investigative Site
Trois-Rivières, Quebec, G9A 3Y2
Czechia3 sites
Novartis Investigative Site
Brno, 638 00
Novartis Investigative Site
Prague, 128 00
Novartis Investigative Site
Uherské Hradiště, 686 01
Hungary3 sites
Novartis Investigative Site
Budapest, 1027
Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Spain3 sites
Novartis Investigative Site
A Coruña, 15006
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
Poland2 sites
Novartis Investigative Site
Krakow, 30-002
Novartis Investigative Site
Lublin, 20-607
About this study
Official title: A Randomized, Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL Pre-filled Syringe With 1 mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.
Read the detailed description
The study consists of the following periods:
Screening period (up to 4 weeks):
Following the signing of the informed consent, participants will be assessed for eligibility during this period of up to 4 weeks.
Treatment Period 1 + Treatment Period 2, (Week 0 to Week 24):
After completion of the screening period, eligible participants will be randomized at the Baseline visit (Week 0) to one of the 2 treatment sequences (treatment switch at Week 12) in a ratio of 1:1 described below:
- Cohort 1:
- Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 2
- Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2
- Cohort 2:
- Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 2
- Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2 In addition, within each sequence, participants will be further randomized to one of the predetermined injection sites with equal allocation, resulting in a total randomization combination of four (2 sequences x 2 injection sites) for Cohort 1 and six (2 sequences x 3 injection sites) for Cohort 2, respectively.
Extended Treatment period (Week 24 to Week 72): After completion of Week 24 assessment, all participants (who did not discontinue during treatment period) will have the option to enter the extended treatment period to receive ianalumab 300 mg s.c. (Cohort 1: 2 mL AI; Cohort 2: 2 x 1 mL PFS) monthly up to Week 68. The end of treatment (EOT) visit will be performed 4 weeks after the last study treatment administration, i.e., at Week 72.
Mandatory Post-Treatment safety follow-up period (from Week 72 to Week 88): Participants who completed the last study treatment or prematurely discontinued from study treatment will enter the post-treatment safety follow-up period.
Conditional Post-Treatment safety follow-up period (from Week 88 to Week 176) Post-treatment follow-up will be performed until B-cell recovery or up to 2 years. B-cell recovery is defined when CD19+ B-cell counts return to >= 50 cells/μL or >= 80% of baseline value, whichever occurs earlier.
- Being tested
- VAY736 1ml PFS, VAY736 2 ml PFS, VAY736 2ml AI
- Keywords
- Sjögrens Disease (SjD), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Pharmacokinetic (PK) comparability, 2 mL auto-injector (AI), 1 mL pre-filled syringe (PFS), 2 mL pre-filled syringe (PFS), VAY736, ianalumab, B cell depletion, Area under the curve (AUC), Cmax
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAY736 1ml PFSBiological
Also called Ianalumab
Solution for injection.
VAY736 2 ml PFSBiological
Also called Ianalumab
Solution for injection
VAY736 2ml AIBiological
Also called Ianalumab
Solution for injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Sequence 1 + Thigh | Experimental | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh
(1 x 2 mL) AI in ETP in Thigh/ Abdomen Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2ml AI |
| Cohort 1: Sequence 1 + Abdomen | Experimental | Patients randomized to receive injection
1. X 2 mL) AI in TP1 in Abdomen
2. x 1 mL) PFS in TP2 in Abdomen
(1 x 2 mL) AI in ETP in Thigh/ Abdomen Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2ml AI |
| Cohort 1: Sequence 2 + Thigh | Experimental | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh
(1 x 2 mL) AI in ETP in Thigh/ Abdomen Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2ml AI |
| Cohort 1: Sequence 2 + Abdomen | Experimental | Patients randomized to receive injection
1. X 2 mL) AI in TP1 in Abdomen
2. x 1 mL) PFS in TP2 in Abdomen
(1 x 2 mL) AI in ETP in Thigh/ Abdomen Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2ml AI |
| Cohort 2: Sequence 1 + Thigh | Experimental | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh
1. X 2 mL) PFS in TP2 in Thigh
2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2 ml PFS |
| Cohort 2: Sequence 1 + Abdomen | Experimental | Patients randomized to receive injection
1. X 2 mL) PFS in TP1 in Abdomen
2. x 1 mL) PFS in TP2 in Abdomen
(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2 ml PFS |
| Cohort 2: Sequence 1 + Upper Arm | Experimental | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Upper Arm
1. X 2 mL) PFS in TP2 in Upper Arm
2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2 ml PFS |
| Cohort 2: Sequence 2 + Thigh | Experimental | Patients randomized to receive injection
1. X 2 mL) PFS in TP1 in Thigh
2. x 1 mL) PFS in TP2 in Thigh
(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2 ml PFS |
| Cohort 2: Sequence 2 + Abdomen | Experimental | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Abdomen
1. X 2 mL) PFS in TP2 in Abdomen
2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2 ml PFS |
| Cohort 2: Sequence 2 + Upper Arm | Experimental | Patients randomized to receive injection
1. X 2 mL) PFS in TP1 in Upper Arm
2. x 1 mL) PFS in TP2 in Upper Arm
(2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm Receives: Biological: VAY736 1ml PFS; Biological: VAY736 2 ml PFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
Measured: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
Measured: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
Cohort 2: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
Measured: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
Cohort 2: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
Measured: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
Secondary outcomes (7)
Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL AI and 2 x 1 mL PFS
Measured: After the 3rd and 6th dose
Cohort 2: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL PFS and 2 x 1 mL PFS
Measured: After the 3rd and 6th dose
Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab
To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL AI and 2 x 1 mL PFS
Measured: At the end of dosing interval
Cohort 2: Concentration at the end of a dosing interval (Ctrough) for ianalumab
To evaluate the pharmacokinetics of ianalumab 300 mg s.c. at steady state under the 1 x 2 mL PFS and 2 x 1 mL PFS
Measured: At the end of dosing interval
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety and tolerability of ianalumab administered 300 mg s.c. monthly.
Measured: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Anti-ianalumab antibodies (ADA)
To assess the immunogenicity of ianalumab administered 300 mg s.c. monthly
Measured: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Incidence of ADA positive participants
To assess the immunogenicity of ianalumab administered 300 mg s.c. monthly
Measured: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start2 Jul 2024
- Primary completion17 Feb 2026
- Study completion16 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögrens DiseaseStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 155 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
- NCT06293365
- Sponsor's protocol ID
- CVAY736A2202
- Other IDs
- 2023-508996-35-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL Pre-filled Syringe With 1 mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
- ClinicalTrials.gov ID
- NCT06293365
- Acronym / sponsor ID
- CVAY736A2202
- Keywords
- Sjögrens Disease (SjD), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Pharmacokinetic (PK) comparability, 2 mL auto-injector (AI), 1 mL pre-filled syringe (PFS), 2 mL pre-filled syringe (PFS), VAY736
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 16 Jan 2029 (estimated)
- First posted
- 5 Mar 2024 (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.
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.
Detailed description
The study consists of the following periods:
Screening period (up to 4 weeks):
Following the signing of the informed consent, participants will be assessed for eligibility during this period of up to 4 weeks.
Treatment Period 1 + Treatment Period 2, (Week 0 to Week 24):
After completion of the screening period, eligible participants will be randomized at the Baseline visit (Week 0) to one of the 2 treatment sequences (treatment switch at Week 12) in a ratio of 1:1 described below:
- Cohort 1:
- Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 2
- Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2
- Cohort 2:
- Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 2
- Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2 In addition, within each sequence, participants will be further randomized to one of the predetermined injection sites with equal allocation, resulting in a total randomization combination of four (2 sequences x 2 injection sites) for Cohort 1 and six (2 sequences x 3 injection sites) for Cohort 2, respectively.
Extended Treatment period (Week 24 to Week 72): After completion of Week 24 assessment, all participants (who did not discontinue during treatment period) will have the option to enter the extended treatment period to receive ianalumab 300 mg s.c. (Cohort 1: 2 mL AI; Cohort 2: 2 x 1 mL PFS) monthly up to Week 68. The end of treatment (EOT) visit will be performed 4 weeks after the last study treatment administration, i.e., at Week 72.
Mandatory Post-Treatment safety follow-up period (from Week 72 to Week 88): Participants who completed the last study treatment or prematurely discontinued from study treatment will enter the post-treatment safety follow-up period.
Conditional Post-Treatment safety follow-up period (from Week 88 to Week 176) Post-treatment follow-up will be performed until B-cell recovery or up to 2 years. B-cell recovery is defined when CD19+ B-cell counts return to >= 50 cells/μL or >= 80% of baseline value, whichever occurs earlier.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Sequence 1 + Thigh | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2ml AIPatients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh (1 x 2 mL) AI in ETP in Thigh/ Abdomen |
| Cohort 1: Sequence 1 + Abdomen | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2ml AIPatients randomized to receive injection 1. X 2 mL) AI in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (1 x 2 mL) AI in ETP in Thigh/ Abdomen |
| Cohort 1: Sequence 2 + Thigh | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2ml AIPatients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh (1 x 2 mL) AI in ETP in Thigh/ Abdomen |
| Cohort 1: Sequence 2 + Abdomen | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2ml AIPatients randomized to receive injection 1. X 2 mL) AI in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (1 x 2 mL) AI in ETP in Thigh/ Abdomen |
| Cohort 2: Sequence 1 + Thigh | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2 ml PFSPatients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh 1. X 2 mL) PFS in TP2 in Thigh 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 1 + Abdomen | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2 ml PFSPatients randomized to receive injection 1. X 2 mL) PFS in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 1 + Upper Arm | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2 ml PFSPatients randomized to receive injection (2 x 1 mL) PFS in TP1 in Upper Arm 1. X 2 mL) PFS in TP2 in Upper Arm 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 2 + Thigh | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2 ml PFSPatients randomized to receive injection 1. X 2 mL) PFS in TP1 in Thigh 2. x 1 mL) PFS in TP2 in Thigh (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 2 + Abdomen | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2 ml PFSPatients randomized to receive injection (2 x 1 mL) PFS in TP1 in Abdomen 1. X 2 mL) PFS in TP2 in Abdomen 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 2 + Upper Arm | Experimental | Biological: VAY736 1ml PFS, Biological: VAY736 2 ml PFSPatients randomized to receive injection 1. X 2 mL) PFS in TP1 in Upper Arm 2. x 1 mL) PFS in TP2 in Upper Arm (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent must be obtained before any assessment is performed.
- Male and female patients aged 18 years to 70 years (inclusive).
- Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2 at screening.
- Diagnosed with RA, SjD and/or SLE as determined by the investigator.
- Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
Key exclusion criteria (8 listed)
- Use of prohibited therapies.
- Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection.
- Plans for administration of live vaccines during the study period.
- Uncontrolled co-existing serious disease.
- 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 |
|---|---|---|
| VAY736 1ml PFSAlso: IanalumabSolution for injection. | Biological | Cohort 1: Sequence 1 + Abdomen, Cohort 1: Sequence 1 + Thigh, Cohort 1: Sequence 2 + Abdomen, Cohort 1: Sequence 2 + Thigh, Cohort 2: Sequence 1 + Abdomen, Cohort 2: Sequence 1 + Thigh, Cohort 2: Sequence 1 + Upper Arm, Cohort 2: Sequence 2 + Abdomen, Cohort 2: Sequence 2 + Thigh, Cohort 2: Sequence 2 + Upper Arm |
| VAY736 2 ml PFSAlso: IanalumabSolution for injection | Biological | Cohort 2: Sequence 1 + Abdomen, Cohort 2: Sequence 1 + Thigh, Cohort 2: Sequence 1 + Upper Arm, Cohort 2: Sequence 2 + Abdomen, Cohort 2: Sequence 2 + Thigh, Cohort 2: Sequence 2 + Upper Arm |
| VAY736 2ml AIAlso: IanalumabSolution for injection. | Biological | Cohort 1: Sequence 1 + Abdomen, Cohort 1: Sequence 1 + Thigh, Cohort 1: Sequence 2 + Abdomen, Cohort 1: Sequence 2 + Thigh |
Primary outcome
Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
Time frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
Time frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
Cohort 2: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
Time frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
Cohort 2: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
Time frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
7 secondary outcomes
Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
Time frame: After the 3rd and 6th dose
Cohort 2: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab
Time frame: After the 3rd and 6th dose
Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab
Time frame: At the end of dosing interval
Cohort 2: Concentration at the end of a dosing interval (Ctrough) for ianalumab
Time frame: At the end of dosing interval
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Anti-ianalumab antibodies (ADA)
Time frame: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Incidence of ADA positive participants
Time frame: From date of randomization until 30 days safety follow-up, assessed up to approximately 56 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
37 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAY736 1ml PFS, VAY736 2 ml PFS and VAY736 2ml AI in people with Sjögrens Disease and Systemic Lupus Erythematosus, run by Novartis Pharmaceuticals at 37 sites in 8 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Argentina, Canada, Czechia, Hungary and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab (time frame: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).). The study lists 4 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 14 Oct 2026.