Status:
WITHDRAWN
An Efficacy and Safety Study of Injectable Ravagalimab to Assess Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) in Adult Participants With Moderately to Severely Active Primary Sjogren's Syndrome (pSS)
Lead Sponsor:
AbbVie
Conditions:
Sjogren's Syndrome (SS)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Sjogren's syndrome (SS) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular en...
Eligibility Criteria
Inclusion
- Primary Sjogren's syndrome (pSS) diagnosed according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2016 Criteria.
- Lymphocyte focus score (local lymphocytic infiltrates) \>= 1 in sublabial salivary gland specimen. Subjects with sublabial salivary gland biopsy obtained 3 months prior to Screening and meeting this criterion will be eligible without a biopsy at Screening. Subjects without a sublabial salivary gland biopsy within 3 months of Screening will obtain a biopsy for a lymphocyte focus score at Screening.
- EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) \>= 5 at Screening.
- EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) \>= 6 at Screening.
Exclusion
- History of clinically significant drug or alcohol abuse within the last 6 months.
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients), the ingredients of Chinese hamster ovary cells and/or other products in the same class.
Key Trial Info
Start Date :
March 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05217472
Start Date
March 6 2020
End Date
May 15 2022
Last Update
February 1 2022
Active Locations (1)
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1
Universitair Medisch Centrum Utrecht /ID# 214029
Utrecht, Netherlands, 3584 CX