An open-label, non-randomized, biopsy-based mechanistic study on pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome - CVAY736A2103

ovartis Pharma AG0 sites20 target enrollmentFebruary 1, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Pharma AG
Enrollment: 20
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 1, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma AG

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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, 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, 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, Known contraindication to SonoVue (sulphur hexafluoride microbubbles) ultrasound contrast agent, 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), Labial minor salivary gland (LMSG) biopsy lymphocyte focus score \< 0\.3 mm2 or B/B\+T ratio in the gland \< 0\.2 (20%), 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, Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically: •?Moderate\-to\-severe active systemic lupus erythematosus (SLE) with anti\-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSPRI or ESSDAI •?Active rheumatoid arthritis (RA) that impedes on the ability to score ESSPRI or ESSDAI •?Systemic sclerosis • Any other concurrent connective tissue disease (e.g., large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's syndrome assessment ESSPRI or ESSDAI., 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