Sjogren SyndromePhase 2NCT05124925

Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.

A Phase 2 study testing Ianalumab in people with Sjogren Syndrome, run by Novartis Pharmaceuticals at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Sjogren Syndrome
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: 21 participants
Where: 1 siteFrance
Study dates: 27 Jul 2022to 5 Jan 2026
Phase: Phase 2
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 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent must be obtained before any assessment is performed
Male and female patients 18 years of age or older at Screening
Confirmed Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria
Seropositive for anti-Ro/SSA antibodies
Screening ESSPRI score ≥ 5
Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Who cannot join

Use of other investigational drugs within 5 half-lives of enrollment or within 30 days whichever is longer, or longer if required by local regulations
Presence of another autoimmune rheumatic disease that is active and constitutes the primary illness
Prior use of ianalumab
History of receiving:
o Any B-cell depleting therapies, other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)
Current use of prednisone >10 mg/day [or equivalent other corticosteroid] or dose change within 2 weeks prior to dosing

Show all 51Show fewer

Prior treatment with any of the following within 6 months of baseline
CTLA4-Fc Ig (abatacept)
Anti-TNF-α mAb
Intravenous Ig
Plasmapheresis
i.v. or oral cyclophosphamide
i.v. or oral cyclosporine A
Patients taking either hydroxychloroquine more than 400 mg/day or methotrexate more than 25 mg weekly or leflunomide at not stable dose within 3 months prior to dosing.
iscalimab (anti-CD40)
belimumab (anti-BAFF mAb)
Active viral, bacterial or other infections
History of major organ, hematopoietic stem cell or bone marrow transplant
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/L-histidine, polysorbate 20)
Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect, and which have not been on a stable dose for at least 30 days prior to Screening, or any anticipated change in the treatment regimen during the course of the study
Receipt of live/attenuated vaccine within a 4-week period prior to baseline
History of primary or secondary immunodeficiency, or a positive HIV (ELISA and Western blot) test result
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin, in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
History of head and neck radiation therapy or of having received radioactive iodine
Any one of the following screening values of CBC laboratory values:
Hemoglobin levels below 8.0 g/dL;
Total leukocyte count less than 2,000/μL;
Platelets <50 x 109/L (if between 50 and 80, the PI should check that it is linked to Sjögren's syndrome and not to any other disease);
Absolute neutrophil count (ANC) <1.0 x 109/L (one re-test is allowed during the screening period)
Positive serology for hepatitis B surface antigen (HBsAg).
Positive serology for hepatitis B core antibody (HBcAb), except if all 3 following criteria are met:
Hepatitis B (HBV) quantitative PCR for viral DNA is negative (i.e., <10 IU)
Prophylactic treatment (with tenofovir or entecavir) initiated latest on day 1 and continued until 12 months after last treatment
Hepatitis B monitoring is implemented: HBsAg (and HBV DNA) tested every 4 weeks during treatment and at least every 12 weeks after end of treatment for the entire duration of the follow-up. Antiviral prophylaxis must be implemented while on study and up to 12 months after end of study treatment.
Positive hepatitis C test result. Participants with a positive HCV antibody test should have HCV RNA levels measured. Participants with positive (detectable) HCV RNA should be excluded.
Evidence of active tuberculosis (TB) infection (after anti-TB treatment, patients with history of or latent TB may become eligible according to national guidelines)
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 6 months after stopping of investigational medication. Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
Male sterilization (at least 6 months prior to screening and confirmed as successful). For female patients in the study, the vasectomized male partner should be the sole partner for that patient
Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).
Known contraindication to SonoVue (sulphur hexafluoride microbubbles) ultrasound contrast agent
Participants not registered in the social security system
Participants within the exclusion period of a preceding study
Any surgical, medical (e.g. uncontrolled hypertension, heart failure or diabetes) psychiatric or additional physical condition that the investigator feels may jeopardize the patient in case of participation in this study
People deprived of their liberty by a judicial or administrative decision (Article L1121-6 of the French Public Health Code)
Screening Labial minor salivary gland (LMSG) biopsy lymphocyte focus score < 0.3/4 mm2 or B/B+T ratio in the gland < 0.2 (20%)
Use of topical ocular prescription medications (excluding artificial tears, gels, lubricants) that have not been on a stable dose for at least 90 days prior to treatment, or any anticipated change in the treatment regimen during the course of the study

Trial locations and contacts

1 site in 1 country.

France1 site

Novartis Investigative Site
Brest, 29200

Other trials in France

About this study

Official title: An Open-label, Non-randomized, Biopsy-based Mechanistic Study on Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ianalumab in Patients With Sjögren's Syndrome

This study aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments

Read the detailed description

This is an open-label, non-randomized, biopsy-based mechanistic study on pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome.

Conditions: Sjogren Syndrome
Being tested: Ianalumab
Keywords: Sjogren syndrome, VAY736, Ianalumab, dry eyes, dry mouth
Medical subject headings: Sjogren's Syndrome, Dry Eye Syndromes, Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IanalumabBiological
Ianalumab VAY736 150mg/1ml Solution for injection

Study groups in NCT05124925
Study group	Role	What they receive
Treatment Arm	Experimental	Ianalumab 300 mg subcutaneous monthly Receives: Biological: Ianalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in logarithm of salivary gland B/B+T cell ratio
Change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25 (EOT)
Measured: Week 25

Secondary outcomes (10)

Number of participants with Adverse Events
Occurrence of treatment emergent adverse events (both serious and non-serious) during the study and occurrence of treatment emergent abnormal vital signs, laboratory and ECG data.
Measured: 6 months treatment plus 2 years of follow-up
Change from baseline in disease activity at salivary gland level by ultrasound imaging
Changes in salivary gland tissue (parenchymal abnormalities, vascularization, perfusion and stiffness) by multimodal salivary gland ultrasound (SGUS) after treatment with ianalumab
Measured: 6 months treatment plus 2 years of follow-up
Incidence of ADA positive patients
Serum anti-ianalumab antibody (ADA assay) and incidence of ADA positive patients as a measure of immunogenicity (IG) of ianalumab
Measured: 6 months treatment plus 2 years of follow-up
Change of salivary flow
Defined as change in stimulated and unstimulated salivary flow from baseline
Measured: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations PK parameters Tmax
To assess the pharmacokinetics (PK) of ianalumab
Measured: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations AUCinf
To assess pharmacokinetics (PK) of ianalumab
Measured: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations C-max
To assess pharmacokinetiks (PK) of ianalumab
Measured: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations PK parameters AUC from dosing to the time of the last measurable concentrations (AUClast)
To assess the pharmacokinetics (PK) of ianalumab
Measured: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations PK parameters half life (T1/2)
To assess the pharmacokinetics (PK) of ianalumab
Measured: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations PK parameters AUC calculated to the end of a dosing interval (tau) at steady state
To assess the pharmacokinetics (PK) of ianalumab
Measured: 6 months treatment plus 2 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 20225 Jan 2026

First posted18 Nov 2021
Study start27 Jul 2022
Primary completion26 Jun 2024
Study completion5 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sjogren SyndromeStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is an open label study (with no control arm) with a 5 weeks screening period, a 6-month treatment period and a follow up period of up to 2 years after the last dose The study consists of a first Run-in Phase that includes Screening and Baseline period of 35 days. After signing the Informed Consent, participants will be assessed as per inclusion/exclusion criteria. All study participants who successfully pass the screening will be considered eligible for the treatment period. All eligible participants will enter the 6 months treatment period and will have the two other biopsies taken at the end of treatment (6 months after the screening) and end of the study (EOS) after blood B cell recovery (from 5 months up to 2 years after the last dose).
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05124925
Sponsor's protocol ID: CVAY736A2103
Other IDs: 2023-508957-24-00, 2023
Status last verified: Jan 2026
First submitted: 8 Nov 2021
Last updated: 2 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sjogren Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Non-randomized, Biopsy-based Mechanistic Study on Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ianalumab in Patients With Sjögren's Syndrome
ClinicalTrials.gov ID: NCT05124925
Acronym / sponsor ID: CVAY736A2103
Conditions: Sjogren Syndrome
Keywords: Sjogren syndrome, VAY736, Ianalumab, dry eyes, dry mouth
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 27 Jul 2022 (actual)
Primary completion: 26 Jun 2024 (actual)
Study completion: 5 Jan 2026 (actual)
First posted: 18 Nov 2021 (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 aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments

Detailed description

This is an open-label, non-randomized, biopsy-based mechanistic study on pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is an open label study (with no control arm) with a 5 weeks screening period, a 6-month treatment period and a follow up period of up to 2 years after the last dose The study consists of a first Run-in Phase that includes Screening and Baseline period of 35 days. After signing the Informed Consent, participants will be assessed as per inclusion/exclusion criteria. All study participants who successfully pass the screening will be considered eligible for the treatment period. All eligible participants will enter the 6 months treatment period and will have the two other biopsies taken at the end of treatment (6 months after the screening) and end of the study (EOS) after blood B cell recovery (from 5 months up to 2 years after the last dose).

Arm	Type	Receives
Treatment Arm	Experimental	Biological: IanalumabIanalumab 300 mg subcutaneous monthly

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Written informed consent must be obtained before any assessment is performed
Male and female patients 18 years of age or older at Screening
Confirmed Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria
Seropositive for anti-Ro/SSA antibodies
Screening ESSPRI score ≥ 5

Key exclusion criteria (51 listed)

Use of other investigational drugs within 5 half-lives of enrollment or within 30 days whichever is longer, or longer if required by local regulations
Presence of another autoimmune rheumatic disease that is active and constitutes the primary illness
Prior use of ianalumab
History of receiving:
o Any B-cell depleting therapies, other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower)

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
IanalumabIanalumab VAY736 150mg/1ml Solution for injection	Biological	Treatment Arm

Primary outcome

Change in logarithm of salivary gland B/B+T cell ratio
Time frame: Week 25
Change from baseline in logarithm of salivary gland B/B+T cell ratio at Week 25 (EOT)

10 secondary outcomes

Number of participants with Adverse Events
Time frame: 6 months treatment plus 2 years of follow-up
Change from baseline in disease activity at salivary gland level by ultrasound imaging
Time frame: 6 months treatment plus 2 years of follow-up
Incidence of ADA positive patients
Time frame: 6 months treatment plus 2 years of follow-up
Change of salivary flow
Time frame: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations PK parameters Tmax
Time frame: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations AUCinf
Time frame: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations C-max
Time frame: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations PK parameters AUC from dosing to the time of the last measurable concentrations (AUClast)
Time frame: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations PK parameters half life (T1/2)
Time frame: 6 months treatment plus 2 years of follow-up
Serum ianalumab concentrations PK parameters AUC calculated to the end of a dosing interval (tau) at steady state
Time frame: 6 months treatment plus 2 years of follow-up

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 Feb 2026.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

Related trials for Sjogren Syndrome

RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ianalumab in people with Sjogren Syndrome, run by Novartis Pharmaceuticals at 1 site in France.

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 6 inclusion and 51 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

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?

Change in logarithm of salivary gland B/B+T cell ratio (time frame: Week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05124925.

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 Feb 2026.