Primary Sjögren's SyndromePhase 2NCT03627065
A Study of INCB050465 in Primary Sjögren's Syndrome
A Phase 2 study testing Parsaclisib in people with Primary Sjögren's Syndrome, run by Incyte Corporation at 4 sites in United States.
Trial summary
The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- Parsaclisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Feb 2019to 2 Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
North Georgia Rheumatology Group
Lawrenceville, Georgia, 30046
Ramesh C. Gupta, MD
Memphis, Tennessee, 38119-5208
Advanced Pharma CR
Miami, Florida, 33147
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: An Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's Syndrome
The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- Parsaclisib
- Keywords
- Primary Sjögren's syndrome, PI3Kδ inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
Also called INCB050465
Parsaclisib administered orally once daily at the protocol-defined dose.
| Study group | Role | What they receive |
|---|---|---|
| Parsaclisib | Experimental | Not described Receives: Drug: Parsaclisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands
The SGUS is a combination of the scores of the 4 salivary glands (2 parotid and 2 submandibular) each gland is scored on a 5-point scale (0 to 4; 4 being more severe), with the maximum total score being 16.
Measured: Week 4 and Week 12
Secondary outcomes (17)
Change From Baseline in Salivary CXCL13 Levels
To assess the impact of parsaclisib on salivary CXCL13.
Measured: Baseline, Week 4 and Week 12
Number of Participants With Treatment-emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to 21 weeks
Change in Whole Salivary Flow
Defined as change in stimulated and unstimulated whole salivary flow from baseline
Measured: Baseline, Weeks 4, 8, and 12
Change in EULAR Sjögren's Syndrome Disease Activity Index
Defined as change in ESSDAI. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity).
Measured: Week 12
Change in EULAR Sjögren's Syndrome Patient Reported Index
Defined as Change in ESSPRI. EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight.
Measured: Weeks 4, 8, and 12
Change in Symptom Scores for Dryness
Defined as change in symptom scores for dryness of eyes, mouth, and vagina. The dryness questionnaire will ask participants to rate the dryness of eyes, mouth, or vagina (female participants only) with 24-hour recall using an 11-point numerical rating system ranging from 0 (no dryness) to 10
Measured: Weeks 4, 8, and 12.
Patient Global Impression of Change Questionnaire
Defined as proportions of participants in each PGIC category. The PGIC asks a single question regarding how the patient is feeling since beginning new therapy. The questionnaire uses a 7-point scale (from 1 to 7), ranging from "very much improved, 1" to "very much worse, 7
Measured: Baseline, Weeks 4, 8, and 12
Change in PROMIS Fatigue Short Form
Defined as change in PROMIS Fatigue short form. The PROMIS fatigue short form includes 7 items with a rating scale of 1 to 5, 1 being no fatigue and 5 being severe fatigue. The recall period is 7 days.
Measured: Weeks 4, 8, and 12
Female Participants Only : Change in Female Sexual Function Index
Defined as change in FSFI. The FSFI is a brief, self-report measure of female sexual function (female participants only). The questionnaire contains 19 item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.
Measured: Weeks 4, 8, and 12
Change in European Quality of Life 5 Dimensions Questionnaire
Defined as change in EQ-5D. The EQ-5D is a standardized measure of health status. It consists of 5 questions, each with a 5-item rating scale plus a visual analog scale rating from 1 to 100 for overall health status. Higher score represents more severe symptoms.
Measured: Weeks 4, 8, and 12
Percentage Change in Whole Salivary Flow
Defined as change and percent change in stimulated and unstimulated whole salivary flow from baseline
Measured: Baseline, Weeks 4, 8, and 12
Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index
Defined as percent change in ESSDAI. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity).
Measured: Week 12
Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index
Defined as percentage change in ESSPRI. EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight.
Measured: Weeks 4, 8, and 12
Percentage Change in Symptom Scores for Dryness
Defined as percent change in symptom scores for dryness of eyes, mouth, and vagina. The dryness questionnaire will ask participants to rate the dryness of eyes, mouth, or vagina (female participants only) with 24-hour recall using an 11-point numerical rating system ranging from 0 (no dryness) to 10
Measured: Weeks 4, 8, and 12.
Percentage Change in PROMIS Fatigue Short Form
Defined as percent change in PROMIS Fatigue short form. The PROMIS fatigue short form includes 7 items with a rating scale of 1 to 5, 1 being no fatigue and 5 being severe fatigue. The recall period is 7 days.
Measured: Weeks 4, 8, and 12
Female Participants Only : Percentage Change in Female Sexual Function Index
Defined as percent change in FSFI. The FSFI is a brief, self-report measure of female sexual function (female participants only). The questionnaire contains 19 item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.
Measured: Weeks 4, 8, and 12
Percentage Change in European Quality of Life 5 Dimensions Questionnaire
Defined as percent change in EQ-5D. The EQ-5D is a standardized measure of health status. It consists of 5 questions, each with a 5-item rating scale plus a visual analog scale rating from 1 to 100 for overall health status. Higher score represents more severe symptoms.
Measured: Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start28 Feb 2019
- Primary completion7 Dec 2019
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Butler, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627065
- Sponsor's protocol ID
- INCB 50465-207
- Other IDs
- Parsaclisib
- Status last verified
- Aug 2021
- First submitted
- 8 Aug 2018
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT03627065
- Acronym / sponsor ID
- INCB 50465-207
- Conditions
- Primary Sjögren's Syndrome
- Keywords
- Primary Sjögren's syndrome, PI3Kδ inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Posted 24 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parsaclisib | Experimental | Drug: Parsaclisib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParsaclisibAlso: INCB050465Parsaclisib administered orally once daily at the protocol-defined dose. | Drug | Parsaclisib |
Primary outcome
Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands
Time frame: Week 4 and Week 12
The SGUS is a combination of the scores of the 4 salivary glands (2 parotid and 2 submandibular) each gland is scored on a 5-point scale (0 to 4; 4 being more severe), with the maximum total score being 16.
17 secondary outcomes
Change From Baseline in Salivary CXCL13 Levels
Time frame: Baseline, Week 4 and Week 12
Number of Participants With Treatment-emergent Adverse Events
Time frame: Up to 21 weeks
Change in Whole Salivary Flow
Time frame: Baseline, Weeks 4, 8, and 12
Change in EULAR Sjögren's Syndrome Disease Activity Index
Time frame: Week 12
Change in EULAR Sjögren's Syndrome Patient Reported Index
Time frame: Weeks 4, 8, and 12
Change in Symptom Scores for Dryness
Time frame: Weeks 4, 8, and 12.
Patient Global Impression of Change Questionnaire
Time frame: Baseline, Weeks 4, 8, and 12
Change in PROMIS Fatigue Short Form
Time frame: Weeks 4, 8, and 12
Female Participants Only : Change in Female Sexual Function Index
Time frame: Weeks 4, 8, and 12
Change in European Quality of Life 5 Dimensions Questionnaire
Time frame: Weeks 4, 8, and 12
Percentage Change in Whole Salivary Flow
Time frame: Baseline, Weeks 4, 8, and 12
Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index
Time frame: Week 12
Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index
Time frame: Weeks 4, 8, and 12
Percentage Change in Symptom Scores for Dryness
Time frame: Weeks 4, 8, and 12.
Percentage Change in PROMIS Fatigue Short Form
Time frame: Weeks 4, 8, and 12
Female Participants Only : Percentage Change in Female Sexual Function Index
Time frame: Weeks 4, 8, and 12
Percentage Change in European Quality of Life 5 Dimensions Questionnaire
Time frame: Weeks 4, 8, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Butler, MD study director
Incyte Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parsaclisib in people with Primary Sjögren's Syndrome, run by Incyte Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands (time frame: Week 4 and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.