A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects with Moderately to Severely Active Primary Sjogren's Syndrome.

Phase 2

Conditions: Primary Sjogrens Syndrome
10003816

Registration Number: NL-OMON48111

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 45

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change from Baseline (CFB) in European League Against Rheumatism (EULAR)<br /><br>Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints including the following:<br /><br>• CFB (Change from baseline) in EULAR Sjogren's Syndrome Disease Activity Index<br /><br>(ESSDAI) at Weeks 4, 8, 12, and 16<br /><br>• CFB in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Weeks 4,<br /><br>8, 12,16, and 24<br /><br>• CFB in tender joint count and swollen joint count (68/66) at Weeks 4, 8, 12,<br /><br>16, and 24<br /><br>• CFB in salivary flow, unstimulated at Weeks 4, 8, 12, 16, and 24<br /><br>• CFB in salivary flow, stimulated, at Weeks 4, 8, 12, 16, and 24<br /><br>• CFB in lacrimal flow (Schirmer's test of ocular function) at Weeks 4, 8, 12,<br /><br>16, and 24<br /><br>• CFB in tear break-up time at Weeks 4, 8, 12,16 and 24<br /><br>• CFB in Functional Assessment of Chronic Illness Therapy-Fatigue<br /><br>(FACIT-Fatigue) at Weeks 4, 8, 12, 16, and 24</p><br>