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Clinical Trials/EUCTR2020-005055-20-FR
EUCTR2020-005055-20-FRActive, not recruitingPhase 1

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

ovartis Pharma AG0 sites24 target enrollmentStarted: November 10, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
24
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Classification of Sjögren's syndrome according to the 2016 ACR/EULAR criteria at screening.
  • •Historical labial minor salivary gland biopsy showing a focus score =1 Seropositive at screening for anti-Ro/SSA antibodies
  • •Screening EULAR Sjögren’s syndrome patient reported index (ESSPRI) score = 5
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 24
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •- Presence of another autoimmune rheumatic disease that is active and constitutes the principle 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.
  • •Prior use of ianalumab
  • •- Prior use of any B cell depleting therapy (e.g., rituximab or other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb within 1 year prior to dosing
  • •- B cell count <50 cells/µL
  • •- Current use of prednisone >10 mg/day [or equivalent other corticosteroid] or dose change within 2 weeks prior to dosing
  • •- Prior treatment with any of the following within 6 months of baseline: CTLA4-Fc Ig (abatacept), Anti-TNF-a 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. 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 that may require systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
  • •- Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect
  • •- For patients undergoing contrast ultrasound: known contraindication to SonoVue (sulphur hexafluoride microbubbles) ultrasound contrast agent
  • •- History of head and neck radiation therapy or of having received
  • •radioactive iodine

Investigators

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