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

NCT04563195 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 56505
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sjogren's Syndrome

Outcome Measures

Primary Outcomes (4)

• whole unstimulated sialometry

  change in unstimulated salivary flow

  baseline

• whole unstimulated sialometry

  change in unstimulated salivary flow

  week 12

• salivary gland ultrasound

  change in salivary gland ultrasound score

  baseline

• salivary gland ultrasound

  change in salivary gland ultrasound score

  week 12

Secondary Outcomes (12)

• ESSDAI

  baseline

• ESSDAI

  week 12

• ESSPRI

  baseline

• ESSPRI

  week 12

• whole stimulated sialometry

  baseline

Study Arms (1)

open label

OTHER

open label study; all subjects will receive the same drug at the same dose

Drug: tibulizumab (LY3090106)

Interventions

tibulizumab (LY3090106) DRUG

subcutaneous injections of 300mg every 2 weeks over a period of 12 weeks

Also known as: open label

open label

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthew C. Baker: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: September 24, 2020
• Study Start: February 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2025
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)