Trial Search Results

BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome

To demonstrate that tibulizumab (LY3090106) treatment improves the mean unstimulated salivary flow rate or the salivary gland total ultrasound score (TUS) in primary Sjogren's syndrome patients at week 12 compared to the baseline visit.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Matthew C. Baker

Stanford Investigator(s):

Intervention(s):

  • Drug: tibulizumab (LY3090106)

Phase:

Phase 2/Phase 3

Eligibility


Inclusion Criteria:

   - Men and women 18-85 years of age

   - Confirmed diagnosis of primary Sjogren's syndrome by the 2016 ACR-EULAR classification
   criteria for primary Sjogren's syndrome

   - All women (regardless of childbearing potential) must test negative for pregnancy at
   the time of screening

   - Women must also agree to use a reliable method of birth control from screening until
   12 weeks following last dose of study drug unless they are not of child bearing
   potential

   - Have stimulated whole salivary flow rate of greater than or equal to 0.10 ml/minute

   - Have a salivary gland total ultrasound score (TUS) of less than or equal to 9 (on a
   0-11 point scale)

Exclusion Criteria:

   - Currently enrolled in a clinical trial involving an investigational product or
   off-label use of a drug

   - Concurrently enrolled in any other type of medical research judged not to be
   scientifically or medically compatible with this study

   - Have received any nonbiologic investigational product within 30 days or 5 half-lives
   (whichever is longer) of their baseline (Day 1) visit

   - Have received any biologic investigational product within 3 months or 5 half-lives
   (whichever is longer) of their baseline visit, or any leukocyte depleting agent within
   12 months of baseline

   - Have disease-modifying antirheumatic drug (DMARD) or immunosuppressive use as follows:

      - ANY treatment with a janus kinase (JAK) inhibitor (including but not limited to
      tofacitinib, baricitinib, upadacitinib, or filgotinib) within 28 days prior to
      baseline or planned treatment with a JAK inhibitor during the study

      - UNSTABLE PRESCRIBED DOSE of other synthetic DMARDs (eg, hydroxychloroquine,
      methotrexate, leflunomide, or sulfasalazine) within 28 days prior to baseline or
      if the dose of drug is planned to be increased during the study (stable
      prescriptions are allowed)

      - ANY treatment with cytotoxic or immunosuppressive drugs including but not limited
      to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or
      tacrolimus within 28 days prior to screening or planned treatment during the
      study

      - Have had treatment with biologic DMARDs as follows: Etanercept, adalimumab, or
      anakinra <4 weeks before baseline or planned treatment during the study

      - Have had treatment with biologic DMARDs as follows: Infliximab, certolizumab
      pegol, golimumab, abatacept, or tocilizumab <8 weeks before baseline or planned
      treatment during the study

   - Are persons who have previously completed or withdrawn from this study

Ages Eligible for Study

18 Years - 85 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting