Ravagalimab Vs Placebo in Subjects with Moderately to Severely Active Primary Sjogren's Syndrome
- Conditions
- Moderately to Severely Active Primary Sjogren's SyndromeMedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-003131-31-NL
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
• Adult male or female, between 18 and 75 years of age, inclusive, at time of the Screening.
• Primary Sjogren’s syndrome (pSS) diagnosed according to the American College of Rheumatology (ACR)/EULAR 2016 Criteria.
• Lymphocyte focus score (local lymphocytic infiltrates) =1 in sub labial salivary gland specimen. Subjects with biopsy obtained 24 months prior to Screening and meeting this criteriona will be eligible but must have a sub labial biopsy obtained at the Baseline Visit. Subjects without a prior sub labial biopsy within 24 months of Screening will obtain a biopsy for a lymphocyte focus score at Screening.
• EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) =5 at Screening and Baseline.
• EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) = 6 at Screening and Baseline.
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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9
1) Female subject who is not pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 84 days.
2) Subjects must have discontinued all immunosuppressants (i.e., azathioprine , methotrexate (MTX), leflunomide (LEF), hydroxychloroquine (HCQ), chloroquine, sulfasalazine, mycophenolate mofetil, rituximab, other biologics, or JAK inhibitors), other than corticosteroids (equivalent to prednisone = 10 mg/day), prior to the Baseline, with the following washout:
• HCQ must be discontinued = 6 months prior to Baseline
• LEF must be discontinued = 6 months prior to Baseline
• 1 year for rituximab OR 6 months if B cells have returned to pretreatment level or normal reference range (local laboratory) if pretreatment levels are not available;
• Discontinuation or modification of all other immunosuppressants must occur = 4 weeks prior to Baseline or at least five times the mean terminal elimination half-life of the drug before undergoing the Baseline, whichever is longer.
3) Subject must not receive IV anti-infectives within 35 days prior to Baseline or oral/intramuscular (IM) anti-infectives within 14 days prior to the Baseline
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method