Phase 2
N=10
A Study of INCB050465 in Primary Sjögren's Syndrome
Primary Sjögren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03627065 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Parsaclisib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands |
0; 0 | — |
| SECONDARY Change From Baseline in Salivary CXCL13 Levels |
0.96; 1.98 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
4 | — |
| SECONDARY Change in Whole Salivary Flow |
0.07; -0.05; -0.05; 0.03; 0.07; 0.04 | — |
| SECONDARY Change in EULAR Sjögren's Syndrome Disease Activity Index |
-0.3; -2.0; -5.3 | — |
| SECONDARY Change in EULAR Sjögren's Syndrome Patient Reported Index |
-1.9; -2.0; -1.8 | — |
| SECONDARY Change in Symptom Scores for Dryness |
-2.6; -2.4; -2.4; -2.8; -2.1; -3.6 | — |
| SECONDARY Patient Global Impression of Change Questionnaire |
0; 0; 0; 9; 0; 0 | — |
| SECONDARY Change in PROMIS Fatigue Short Form |
-2.6; -1.9; -1.7 | — |
| SECONDARY Female Participants Only : Change in Female Sexual Function Index |
1.8; 2.8; 1.3 | — |
| SECONDARY Change in European Quality of Life 5 Dimensions Questionnaire |
7.2; 0.7; -6.4 | — |
| SECONDARY Percentage Change in Whole Salivary Flow |
17.57; -10.59; -16.07; 228.10; 307.56; 281.12 | — |
| SECONDARY Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index |
1.8; -5.2; -32.1 | — |
| SECONDARY Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index |
-24.4; -29.0; -25.8 | — |
| SECONDARY Percentage Change in Symptom Scores for Dryness |
-33.2; -39.3; -40.9; -37.7; -28.0; -50.9 | — |
| SECONDARY Percentage Change in PROMIS Fatigue Short Form |
-11.1; -7.5; -6.4 | — |
| SECONDARY Female Participants Only : Percentage Change in Female Sexual Function Index |
39.0; 8.7; 23.3 | — |
| SECONDARY Percentage Change in European Quality of Life 5 Dimensions Questionnaire |
21.1; 11.9; -8.9 | — |
Summary
The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).
Eligibility Criteria
Inclusion Criteria
- Primary SS diagnosed according to the revised American-European Consensus Group (AECG) criteria.
- Minimum score of 2 on the SGUS score for parotid and submandibular glands.
- EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 5.
- Positive serum titers of anti-SS-A and/or anti-SS-B antibodies.
- Symptomatic oral dryness score of at least 5 on patient questionnaire.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria
- Diagnosis of secondary SS according to the revised AECG criteria (eg, the presence of a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis, dermatomyositis, immunoglobulin G4-related disorder, sarcoidosis, or any other defined autoimmune rheumatologic disorder).
- Concurrent conditions and history of other diseases per protocol-defined criteria.
- Positive test results for tuberculosis (TB) from the QuantiFERON-TB Gold test or T-spot.TB test.
- Positive serology test results for HIV antibody, hepatitis B surface antigen, hepatitis B surface antigen antibody, HBV core antibody, or HCV (HCV antibody with positive HCV-RNA).
- Severely impaired liver function (Child-Pugh Class C).
- Prior or ongoing therapy with protocol-defined drugs.
- Receipt of any live vaccine in the 30 days before screening.
- No major surgery within 30 days before screening. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
- Current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the dose regimen and study evaluations.
- Laboratory values at screening outside the protocol-defined ranges.
Data sourced from ClinicalTrials.gov (NCT03627065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.