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Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships with Clinical Assessments
EU CTIS ID: 2023-508957-24-00
What this study is testing
To investigate changes in salivary gland histopathology after treatment with ianalumab
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent must be obtained before any assessment is performed.
- Male and female patients 18 years of age or older at Screening.
- Classification of Sjögren's syndrome according to the 2016 ACR/EULAR criteria at screening.
- Seropositive at screening for anti-Ro/SSA antibodies
- Screening EULAR Sjögren’s syndrome patient reported index (ESSPRI) score ≥ 5
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
You likely can't join if
- 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 principal illness.
- 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)
- Evidence of patients with history of or 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
- Participants not registered in the social security system
See the full eligibility criteria
Who can join
- Written informed consent must be obtained before any assessment is performed.
- Male and female patients 18 years of age or older at Screening.
- Classification of Sjögren's syndrome according to the 2016 ACR/EULAR criteria at screening.
- Seropositive at screening for anti-Ro/SSA antibodies
- Screening EULAR Sjögren’s syndrome patient reported index (ESSPRI) score ≥ 5
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
What rules you out
- 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 principal illness.
- 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)
- Evidence of patients with history of or 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
- Participants not registered in the social security system
- Participants within the exclusion period of a preceding study
- 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
- 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
- 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
- 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, - Iscalimab (anti-CD40), - Belimumab (anti-BAFF mAb)
- 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. Patients who are taking the above-mentioned drugs can be included if dose is within the mentioned limits and maintained at stable dose throughout the study
- Active viral, bacterial or other infections.
- History of major organ, hematopoietic stem cell or bone marrow transplant
- 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
- History of head and neck radiation therapy or of having received radioactive iodine
- 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 L 1121-6 of the French Public Health Code)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.