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).
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change from Baseline (CFB) in European League Against Rheumatism (EULAR)
Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24.
Secondary outcome
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
Background 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 enlargement. In
addition, a variety of systemic manifestations may occur; including fatigue,
musculoskeletal symptoms, rashes, and internal organ (e.g., pulmonary, renal,
hepatic, and neurologic) disease. Sjogren's syndrome may occur in isolation,
primary Sjogren's syndrome (pSS), or in a secondary form, often associated with
rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), or systemic
sclerosis. Ravagalimab is an investigational drug being developed to help
treat patients with inflammatory diseases like SS. This study will evaluate
how well ravagalimab works within the body and how safe it is in patients with
Primary SS (pSS).
Study 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).
Study design
Randomised, double blind, parallel group, placebo controlled.
Intervention
Ravagalimab intravenous (IV) loading dose or IV placebo at baseline followed by
subcutaneous (SC) ravagalimab or matching placebo.
Study burden and risks
• CFB in patient and physician global assessments using Numeric Rate Scale
(NRS) at Week 4, 8, 12, 16, and 24
• CFB in anti-Sjogrens-syndrome-related-antigen A (Anti-SSA),
anti-Sjogrens-syndrome-related-antigen B (Anti-SSB), antinuclear antibody (ANA)
and rheumatoid factor (RF) at Weeks 4, 12, and 24
• CFB in high-sensitivity C-reactive protein (hsCRP), immunoglobulins M, G, and
A, 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.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
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 criterion 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.
Exclusion criteria
1) Female subject who is 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003131-31-NL |
| CCMO | NL71251.056.19 |