Primary Sjögren's Syndrome
Conditions
Keywords
Primary Sjögren's syndrome, PI3Kδ inhibitor
Brief summary
The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).
Interventions
DRUGParsaclisib
Parsaclisib administered orally once daily at the protocol-defined dose.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Up to 21 weeks | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. |
| Change in Whole Salivary Flow | Baseline, Weeks 4, 8, and 12 | Defined as change in stimulated and unstimulated whole salivary flow from baseline |
| Change in EULAR Sjögren's Syndrome Disease Activity Index | Week 12 | 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). |
| Change in EULAR Sjögren's Syndrome Patient Reported Index | Weeks 4, 8, and 12 | 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. |
| Change in Symptom Scores for Dryness | Weeks 4, 8, and 12. | 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 |
| Patient Global Impression of Change Questionnaire | Baseline, Weeks 4, 8, and 12 | 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 |
| Change in PROMIS Fatigue Short Form | Weeks 4, 8, and 12 | 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. |
| Female Participants Only : Change in Female Sexual Function Index | Weeks 4, 8, and 12 | 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. |
| Change From Baseline in Salivary CXCL13 Levels | Baseline, Week 4 and Week 12 | To assess the impact of parsaclisib on salivary CXCL13. |
| Percentage Change in Whole Salivary Flow | Baseline, Weeks 4, 8, and 12 | Defined as change and percent change in stimulated and unstimulated whole salivary flow from baseline |
| Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index | Week 12 | 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). |
| Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index | Weeks 4, 8, and 12 | 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. |
| Percentage Change in Symptom Scores for Dryness | Weeks 4, 8, and 12. | 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 |
| Percentage Change in PROMIS Fatigue Short Form | Weeks 4, 8, and 12 | 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. |
| Female Participants Only : Percentage Change in Female Sexual Function Index | Weeks 4, 8, and 12 | 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. |
| Percentage Change in European Quality of Life 5 Dimensions Questionnaire | Weeks 4, 8, and 12 | 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. |
| Change in European Quality of Life 5 Dimensions Questionnaire | Weeks 4, 8, and 12 | 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. |
Countries
United States
Participant flow
Recruitment details
Approximately 12 participants were planned. Ten participants were enrolled and analyzed for efficacy and safety.
Pre-assignment details
Ten participants were enrolled and treated. Seven participants completed treatment. Three participants discontinued treatment and withdrew from the study.
Participants by arm
| Arm | Count |
|---|---|
| Parsaclisib parsaclisib was administered orally once a day for up to 12 weeks. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Terminated by sponsor | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Parsaclisib |
|---|---|
| Age, Continuous | 54.1 Years STANDARD_DEVIATION 13.47 |
| Race/Ethnicity, Customized Black/African-American | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 9 Participants |
| Race/Ethnicity, Customized White/Caucasian | 4 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: Week 4 and Week 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parsaclisib | Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands | Week 4 | 0 Participants |
| Parsaclisib | Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands | Week 12 | 0 Participants |
Secondary
Change From Baseline in Salivary CXCL13 Levels
To assess the impact of parsaclisib on salivary CXCL13.
Time frame: Baseline, Week 4 and Week 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug, and detectable levels of CXCL13.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Change From Baseline in Salivary CXCL13 Levels | Week 4 | 0.96 L/h | Standard Deviation 0.1 |
| Parsaclisib | Change From Baseline in Salivary CXCL13 Levels | Week 12 | 1.98 L/h | Standard Deviation 1.4 |
Secondary
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).
Time frame: Week 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Change in EULAR Sjögren's Syndrome Disease Activity Index | Mean Change at Week 4 | -0.3 Index | Standard Deviation 2.92 |
| Parsaclisib | Change in EULAR Sjögren's Syndrome Disease Activity Index | Mean Change at Week 8 | -2.0 Index | Standard Deviation 4.12 |
| Parsaclisib | Change in EULAR Sjögren's Syndrome Disease Activity Index | Mean Change at Week 12 | -5.3 Index | Standard Deviation 4.15 |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Change in EULAR Sjögren's Syndrome Patient Reported Index | Mean Change at Week 4 | -1.9 Index | Standard Deviation 2.26 |
| Parsaclisib | Change in EULAR Sjögren's Syndrome Patient Reported Index | Mean Change at Week 8 | -2.0 Index | Standard Deviation 1.93 |
| Parsaclisib | Change in EULAR Sjögren's Syndrome Patient Reported Index | Mean Change at Week 12 | -1.8 Index | Standard Deviation 1.98 |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Change in European Quality of Life 5 Dimensions Questionnaire | Change in EQ5D at week 4 | 7.2 Scores on a scale | Standard Deviation 17.34 |
| Parsaclisib | Change in European Quality of Life 5 Dimensions Questionnaire | Change in EQ5D at week 8 | 0.7 Scores on a scale | Standard Deviation 28.05 |
| Parsaclisib | Change in European Quality of Life 5 Dimensions Questionnaire | Change in EQ5D at week 12 | -6.4 Scores on a scale | Standard Deviation 22.49 |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Change in PROMIS Fatigue Short Form | Change in Score at Week 4 | -2.6 Scores on a scale | Standard Deviation 4.03 |
| Parsaclisib | Change in PROMIS Fatigue Short Form | Change in Score at Week 8 | -1.9 Scores on a scale | Standard Deviation 2.79 |
| Parsaclisib | Change in PROMIS Fatigue Short Form | Change in Score at Week 12 | -1.7 Scores on a scale | Standard Deviation 2.87 |
Secondary
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
Time frame: Weeks 4, 8, and 12.
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for eye dryness at Week 4 | -2.6 Scores on a scale | Standard Deviation 2.96 |
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for eye dryness at Week 8 | -2.4 Scores on a scale | Standard Deviation 2.07 |
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for eye dryness at Week 12 | -2.4 Scores on a scale | Standard Deviation 2.64 |
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for mouth dryness at Week 4 | -2.8 Scores on a scale | Standard Deviation 2.64 |
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for mouth dryness at Week 8 | -2.1 Scores on a scale | Standard Deviation 2.41 |
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for mouth dryness at Week 12 | -3.6 Scores on a scale | Standard Deviation 2.99 |
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for vaginal dryness at Week 4 | -1.3 Scores on a scale | Standard Deviation 3.2 |
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for vaginal dryness at Week 8 | -2.3 Scores on a scale | Standard Deviation 3.5 |
| Parsaclisib | Change in Symptom Scores for Dryness | Change in Symptom Score for vaginal dryness at Week 12 | -1.3 Scores on a scale | Standard Deviation 2.94 |
Secondary
Change in Whole Salivary Flow
Defined as change in stimulated and unstimulated whole salivary flow from baseline
Time frame: Baseline, Weeks 4, 8, and 12
Population: The full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Change in Whole Salivary Flow | Mean change in stimulated salivary flow Week 4 | 0.07 g/min | Standard Deviation 0.152 |
| Parsaclisib | Change in Whole Salivary Flow | Mean change in stimulated salivary flow Week 8 | -0.05 g/min | Standard Deviation 0.129 |
| Parsaclisib | Change in Whole Salivary Flow | Mean change in stimulated salivary flow Week 12 | -0.05 g/min | Standard Deviation 0.144 |
| Parsaclisib | Change in Whole Salivary Flow | Mean change in unstimulated salivary flow Week 4 | 0.03 g/min | Standard Deviation 0.046 |
| Parsaclisib | Change in Whole Salivary Flow | Mean change in unstimulated salivary flow Week 8 | 0.07 g/min | Standard Deviation 0.109 |
| Parsaclisib | Change in Whole Salivary Flow | Mean change in unstimulated salivary flow Week 12 | 0.04 g/min | Standard Deviation 0.082 |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set included all female participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Female Participants Only : Change in Female Sexual Function Index | Change in Functional Index at Week 4 | 1.8 Index | Standard Deviation 3.19 |
| Parsaclisib | Female Participants Only : Change in Female Sexual Function Index | Change in Functional Index at Week 8 | 2.8 Index | Standard Deviation 4.76 |
| Parsaclisib | Female Participants Only : Change in Female Sexual Function Index | Change in Functional Index at Week 12 | 1.3 Index | Standard Deviation 1.83 |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set included all female participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Female Participants Only : Percentage Change in Female Sexual Function Index | Percent change in Functional Index at Week 4 | 39.0 Percentage Change | Standard Deviation 94.61 |
| Parsaclisib | Female Participants Only : Percentage Change in Female Sexual Function Index | Percent change in Functional Index at Week 8 | 8.7 Percentage Change | Standard Deviation 31.63 |
| Parsaclisib | Female Participants Only : Percentage Change in Female Sexual Function Index | Percent change in Functional Index at Week 12 | 23.3 Percentage Change | Standard Deviation 30.08 |
Secondary
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.
Time frame: Up to 21 weeks
Population: The full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parsaclisib | Number of Participants With Treatment-emergent Adverse Events | 4 Participants |
Secondary
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
Time frame: Baseline, Weeks 4, 8, and 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Parsaclisib | Patient Global Impression of Change Questionnaire | Baseline | Very Much Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Baseline | Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Baseline | Somewhat Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Baseline | No Change | 9 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Baseline | Somewhat Improved | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Baseline | Improved | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Baseline | Very much Improved | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 4 | Very Much Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 4 | Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 4 | Somewhat Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 4 | No Change | 3 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 4 | Somewhat Improved | 2 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 4 | Improved | 4 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 4 | Very much Improved | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 8 | Very Much Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 8 | Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 8 | Somewhat Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 8 | No Change | 2 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 8 | Somewhat Improved | 2 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 8 | Improved | 3 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 8 | Very much Improved | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 12 | Very Much Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 12 | Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 12 | Somewhat Worse | 0 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 12 | No Change | 2 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 12 | Somewhat Improved | 2 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 12 | Improved | 3 Participants |
| Parsaclisib | Patient Global Impression of Change Questionnaire | Week 12 | Very much Improved | 0 Participants |
Secondary
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).
Time frame: Week 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index | Percent Change at Week 4 | 1.8 Percentage Change | Standard Deviation 28.13 |
| Parsaclisib | Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index | Percent Change at Week 8 | -5.2 Percentage Change | Standard Deviation 24.09 |
| Parsaclisib | Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index | Percent Change at Week 12 | -32.1 Percentage Change | Standard Deviation 25.7 |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index | Percent Change at Week 4 | -24.4 Percentage Change | Standard Deviation 40.36 |
| Parsaclisib | Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index | Percent Change at Week 8 | -29.0 Percentage Change | Standard Deviation 28.27 |
| Parsaclisib | Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index | Percent Change at Week 12 | -25.8 Percentage Change | Standard Deviation 30.52 |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Percentage Change in European Quality of Life 5 Dimensions Questionnaire | Percent Change in EQ5D at week 4 | 21.1 Percentage Change | Standard Deviation 55.37 |
| Parsaclisib | Percentage Change in European Quality of Life 5 Dimensions Questionnaire | Percent Change in EQ5D at week 8 | 11.9 Percentage Change | Standard Deviation 62.91 |
| Parsaclisib | Percentage Change in European Quality of Life 5 Dimensions Questionnaire | Percent Change in EQ5D at week 12 | -8.9 Percentage Change | Standard Deviation 49.54 |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Percentage Change in PROMIS Fatigue Short Form | Percent change in Score at Week 4 | -11.1 Percentage Change | Standard Deviation 21.87 |
| Parsaclisib | Percentage Change in PROMIS Fatigue Short Form | Percent change in Score at Week 8 | -7.5 Percentage Change | Standard Deviation 13.17 |
| Parsaclisib | Percentage Change in PROMIS Fatigue Short Form | Percent change in Score at Week 12 | -6.4 Percentage Change | Standard Deviation 13.16 |
Secondary
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
Time frame: Weeks 4, 8, and 12.
Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for eye dryness at Week 4 | -33.2 Percentage Change | Standard Deviation 35.29 |
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for eye dryness at Week 8 | -39.3 Percentage Change | Standard Deviation 23.89 |
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for eye dryness at Week 12 | -40.9 Percentage Change | Standard Deviation 39.09 |
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for mouth dryness at Week 4 | -37.7 Percentage Change | Standard Deviation 37.56 |
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for mouth dryness at Week 8 | -28.0 Percentage Change | Standard Deviation 32.97 |
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for mouth dryness at Week 12 | -50.9 Percentage Change | Standard Deviation 45.88 |
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for vaginal dryness at Week 4 | -24.0 Percentage Change | Standard Deviation 49.18 |
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for vaginal dryness at Week 8 | -54.2 Percentage Change | Standard Deviation 51.59 |
| Parsaclisib | Percentage Change in Symptom Scores for Dryness | Percent change in Symptom Score for vaginal dryness at Week 12 | -49.0 Percentage Change | Standard Deviation 42.54 |
Secondary
Percentage Change in Whole Salivary Flow
Defined as change and percent change in stimulated and unstimulated whole salivary flow from baseline
Time frame: Baseline, Weeks 4, 8, and 12
Population: The full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parsaclisib | Percentage Change in Whole Salivary Flow | Percent change in stimulated salivary flow Week 8 | -10.59 Percentage Change | Standard Deviation 32.874 |
| Parsaclisib | Percentage Change in Whole Salivary Flow | Percent change in stimulated salivary flow Week 4 | 17.57 Percentage Change | Standard Deviation 36.225 |
| Parsaclisib | Percentage Change in Whole Salivary Flow | Percent change in stimulated salivary flow Week 12 | -16.07 Percentage Change | Standard Deviation 41.754 |
| Parsaclisib | Percentage Change in Whole Salivary Flow | Percent change in unstimulated salivary flow Week 4 | 228.10 Percentage Change | Standard Deviation 282.634 |
| Parsaclisib | Percentage Change in Whole Salivary Flow | Percent change in unstimulated salivary flow Week 8 | 307.56 Percentage Change | Standard Deviation 601.557 |
| Parsaclisib | Percentage Change in Whole Salivary Flow | Percent change in unstimulated salivary flow Week 12 | 281.12 Percentage Change | Standard Deviation 541.333 |