Moderately to Severely Active Primary Sjogren's Syndrome MedDRA version: 21.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Ravagalimab
Product Code: ABBV-323
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: Ravagalimab
Current Sponsor code: ABBV-323
Other d
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of ravagalimab vs placebo for the treatment of Primary Sjogren's Syndrome (pSS) in subjects with moderately to severely active Primary Sjogren's Syndrome (pSS).;Secondary Objective: Not applicable;Primary end point(s): The change from Baseline (CFB) in EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI) ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints including the following: • CFB (Change from baseline) in EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI) at Weeks 4, 8, 12, and 16 • CFB in EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI) at Weeks 4, 8, 12,16, and 24 • CFB in tender joint count and swollen joint count (68/66) at Weeks 4, 8, 12, 16, and 24 • CFB in salivary flow, unstimulated at Weeks 4, 8, 12, 16, and 24 • CFB in salivary flow, stimulated, at Weeks 4, 8, 12, 16, and 24 • CFB in lacrimal flow (Schirmer’s test of ocular function) at Weeks 4, 8, 12, 16, and 24 • CFB in tear break-up time at Weeks 4, 8, 12,16 and 24 • CFB in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Weeks 4, 8, 12, 16, and 24 • CFB in patient and physician global assessments using Numeric Rate Scale (NRS) at Week 4, 8, 12, 16, and 24 • CFB in Anti-SSA, Anti-SSB, ANA and RF at Weeks 4, 12, and 24 • CFB in hsCRP, IgM, IgG, IgA, Serum free light chains, C3, C4 and CH50 at Weeks 4, 8, 12, 16, and 24 • CFB in Focus score of sub-labial gland biopsy at Week 24.;Timepoint(s) of evaluation of this end point: Weeks 4, 8, 12, 16, and 24 | — |
Countries
Netherlands
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed