Three-arm study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjögren’s syndrome
- Conditions
- Sjögren’s SyndromeMedDRA version: 21.0Level: PTClassification code: 10040767Term: Sjogren's syndrome Class: 100000004859MedDRA version: 20.0Level: LLTClassification code: 10023351Term: Keratoconjunctivitis sicca not specified as Sjogren's Class: 10015919MedDRA version: 21.0Level: LLTClassification code: 10040765Term: Sjogren's Class: 10028395MedDRA version: 21.0Level: LLTClassification code: 10040766Term: Sjogren's disease Class: 10028395MedDRA version: 21.0Level: LLTClassification code: 10042846Term: Syndrome Sjogren's Class: 10028395Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-511068-10-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 492
Signed informed consent must be obtained prior to participation in the study, Patients taking systemic corticosteroids have to be on a stable dose of = 10 mg/day predniso(lo)ne or equivalent for at least 30 days before randomization. Stable dose should be maintained throughout the 52 weeks of the blinded treatment period of the study, however limited increases of the corticosteroid dose for a limited time and tapering of background steroids are allowed during the course of the study as described in Protocol Section 6.2.1, Patients taking: •disease-modifying antirheumatic drugs (DMARDs) other than specifically allowed in inclusion criterion #9, or •the following Traditional Chinese Medicines: Total glucoside of peony (TGP) or Tripterium glycosides (TG) must discontinue these medications at least 30 days prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed., Women and men = 18 years of age, Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria (Shiboski et al 2017), Time since diagnosis of Sjögren's of = 7.5 years at screening, Positive anti-Ro/SSA antibody at screening: •Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review •Enrollment of anti-Ro/SSA-negative patients will be limited up to =10% of the study population, Screening ESSDAI score of =5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic., Stimulated whole salivary flow (sSF) rate of = 0.05 mL/min at screening, Ability to communicate well with the Investigator, understand and agree to comply with the requirements of the study, Patients taking hydroxychloroquine (= 400 mg/day), methotrexate (= 25 mg/week) or azathioprine (= 150 mg/day) alone or in combination are allowed to continue their medication and must have been on a stable dose for at least 30 days prior to randomization. Stable dose within the predefined dose limits should be maintained throughout the 52 weeks of the blinded treatment period of the study
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 ESSDAI domains •Active rheumatoid arthritis (RA) that impedes on the ability to score the ESSDAI articular domain •Systemic sclerosis •Any other concurrent connective tissue disease (e.g., lupus nephritis (LN), 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 organ domain assessments., Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the subject. •HBsAg negative subjects who are hepatitis B core antibody (HBcAb) positive are also excluded unless all of the following criteria are met: oHBV DNA is negative ohepatitis B monitoring is implemented - in these subjects monthly testing of HBsAg and HBV DNA must be performed while on study treatment and at least every 12 weeks after end of treatment for the entire duration of safety follow-up. oAntiviral prophylaxis must be implemented before the first administration of the study treatment and continued up to 12 months after end of study treatment. If antiviral therapy cannot be given or if the patient is not willing to comply with the antiviral treatment requirement, the patient is not eligible for the study. •Hepatitis C: Patients with positive Hep C antibody and HCV RNA at screening are excluded. Chronic hepatitis C patients who have completed HCV anti-viral treatment must be HCV-RNA negative at least 12 weeks after treatment before randomization to be eligible. Cases of spontaneous HCV clearance should be discussed with sponsor before enrollment., Evidence of active tuberculosis (TB) infection is exclusionary. Patient with previously treated TB and previously treated or newly diagnosed latent TB may be eligible (after anti-TB treatment, patients with history of or latent TB may become eligible according to national guidelines), History of major organ, hematopoietic stem cell or bone marrow transplant., Required regular use of medications known to cause dry mouth/eyes as 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., 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 randomization, 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 randomization., History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) (ELISA and Western blot) test result., History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer or Sjögren’s related lymphoma), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases., History of sarcoidosis, Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes mellitus), psychiatric or additional physical
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method