CompletedPhase 2

A Study of INCB050465 in Primary Sjögren's Syndrome

United States10 participantsStarted 2019-02-28

Plain-language summary

The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. Inadequa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT03627065

SponsorIncyte Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-07

Results submitted2020-12-07

View on ClinicalTrials.gov More Primary Sjögren's Syndrome trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.