Clinical trial NCT03627065: A Study of INCB050465 in Primary Sjögren's Syndrome
Official title: An Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Sjögren's Syndrome
Keywords: Primary Sjögren's syndrome
PI3Kδ inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands
timeFrame: Week 4 and Week 12
Secondary outcomes:
measure: Change From Baseline in Salivary CXCL13 Levels
timeFrame: Baseline, Week 4 and Week 12
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: Up to 21 weeks
measure: Change in Whole Salivary Flow
timeFrame: Baseline, Weeks 4, 8, and 12
measure: Change in EULAR Sjögren's Syndrome Disease Activity Index
timeFrame: Week 12
measure: Change in EULAR Sjögren's Syndrome Patient Reported Index
timeFrame: Weeks 4, 8, and 12
measure: Change in Symptom Scores for Dryness
timeFrame: Weeks 4, 8, and 12.
measure: Patient Global Impression of Change Questionnaire
timeFrame: Baseline, Weeks 4, 8, and 12
measure: Change in PROMIS Fatigue Short Form
timeFrame: Weeks 4, 8, and 12
measure: Female Participants Only : Change in Female Sexual Function Index
timeFrame: Weeks 4, 8, and 12
measure: Change in European Quality of Life 5 Dimensions Questionnaire
timeFrame: Weeks 4, 8, and 12
measure: Percentage Change in Whole Salivary Flow
timeFrame: Baseline, Weeks 4, 8, and 12
measure: Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index
timeFrame: Week 12
measure: Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index
timeFrame: Weeks 4, 8, and 12
measure: Percentage Change in Symptom Scores for Dryness
timeFrame: Weeks 4, 8, and 12.
measure: Percentage Change in PROMIS Fatigue Short Form
timeFrame: Weeks 4, 8, and 12
measure: Female Participants Only : Percentage Change in Female Sexual Function Index
timeFrame: Weeks 4, 8, and 12
measure: Percentage Change in European Quality of Life 5 Dimensions Questionnaire
timeFrame: Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: Advanced Pharma CR
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group
state: Georgia
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Memphis
country: United States
facility: Ramesh C. Gupta, MD
state: Tennessee
Study officials:
affiliation: Incyte Corporation
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
References: