Clinical trial NCT04563195: BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome
Official title: BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Primary Sjogren's Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This will be a single-site, open-label study in patients with primary Sjogren's syndrome. All patients will receive tibulizumab (LY3090106) 300mg subcutaneously every 2 weeks for a total of 12 weeks.

Primary Sjogren's syndrome was selected as a relevant patient population based on the mechanism of action of the molecule and the current understanding of the pathogenesis of the disease. An open-label design was chosen based on practical considerations regarding the number of patients that could be recruited. Although open-label studies are subject to bias, objective primary endpoints were intentionally chosen to minimize this concern.

The goal of this study is 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.

Eligibility criteria: 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

Primary outcomes:
measure: whole unstimulated sialometry
timeFrame: baseline
measure: whole unstimulated sialometry
timeFrame: week 12
measure: salivary gland ultrasound
timeFrame: baseline
measure: salivary gland ultrasound
timeFrame: week 12
Secondary outcomes:
measure: ESSDAI
timeFrame: baseline
measure: ESSDAI
timeFrame: week 12
measure: ESSPRI
timeFrame: baseline
measure: ESSPRI
timeFrame: week 12
measure: whole stimulated sialometry
timeFrame: baseline
measure: whole stimulated sialometry
timeFrame: week 12
measure: Schirmer I test
timeFrame: baseline
measure: Schirmer I test
timeFrame: week 12
measure: MRI
timeFrame: baseline
measure: MRI
timeFrame: week 12
measure: PET
timeFrame: baseline
measure: PET
timeFrame: week 12
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: