A Phase 2 interventional study of Parsaclisib in Primary Sjögren's Syndrome, sponsored by Incyte Corporation. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-13.
Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).
372 studies on the registry are indexed under Sjogren's Syndrome; 105 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 245 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Parsaclisib
Parsaclisib administered orally once daily at the protocol-defined dose.
Also known as: INCB050465
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
Change From Baseline in Salivary CXCL13 Levels
To assess the impact of parsaclisib on salivary CXCL13.
Time frame: 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.
Time frame: Up to 21 weeks
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
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
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
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.
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
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
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
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
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
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
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
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.
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
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
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
Approximately 12 participants were planned. Ten participants were enrolled and analyzed for efficacy and safety.
| Milestone | Parsaclisib |
|---|---|
| Started | 10 |
| Completed | 7 |
| Not completed | 3 |
| Withdrew: Study terminated by sponsor | 1 |
| Withdrew: Withdrawal by subject | 2 |
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.
| Participants | Parsaclisib |
|---|---|
| Week 4 | 0 |
| Week 12 | 0 |
To assess the impact of parsaclisib on salivary CXCL13.
| L/h | Parsaclisib |
|---|---|
| Week 4 | 0.96 ± 0.1 |
| Week 12 | 1.98 ± 1.4 |
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
| Participants | Parsaclisib |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events | 4 |
Defined as change in stimulated and unstimulated whole salivary flow from baseline
| g/min | Parsaclisib |
|---|---|
| Mean change in stimulated salivary flow Week 4 | 0.07 ± 0.152 |
| Mean change in stimulated salivary flow Week 8 | -0.05 ± 0.129 |
| Mean change in stimulated salivary flow Week 12 | -0.05 ± 0.144 |
| Mean change in unstimulated salivary flow Week 4 | 0.03 ± 0.046 |
| Mean change in unstimulated salivary flow Week 8 | 0.07 ± 0.109 |
| Mean change in unstimulated salivary flow Week 12 | 0.04 ± 0.082 |
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).
| Index | Parsaclisib |
|---|---|
| Mean Change at Week 4 | -0.3 ± 2.92 |
| Mean Change at Week 8 | -2.0 ± 4.12 |
| Mean Change at Week 12 | -5.3 ± 4.15 |
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.
| Index | Parsaclisib |
|---|---|
| Mean Change at Week 4 | -1.9 ± 2.26 |
| Mean Change at Week 8 | -2.0 ± 1.93 |
| Mean Change at Week 12 | -1.8 ± 1.98 |
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
| Scores on a scale | Parsaclisib |
|---|---|
| Change in Symptom Score for eye dryness at Week 4 | -2.6 ± 2.96 |
| Change in Symptom Score for eye dryness at Week 8 | -2.4 ± 2.07 |
| Change in Symptom Score for eye dryness at Week 12 | -2.4 ± 2.64 |
| Change in Symptom Score for mouth dryness at Week 4 | -2.8 ± 2.64 |
| Change in Symptom Score for mouth dryness at Week 8 | -2.1 ± 2.41 |
| Change in Symptom Score for mouth dryness at Week 12 | -3.6 ± 2.99 |
| Change in Symptom Score for vaginal dryness at Week 4 | -1.3 ± 3.20 |
| Change in Symptom Score for vaginal dryness at Week 8 | -2.3 ± 3.50 |
| Change in Symptom Score for vaginal dryness at Week 12 | -1.3 ± 2.94 |
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
| Participants | Parsaclisib |
|---|---|
| Baseline — Very Much Worse | 0 |
| Baseline — Worse | 0 |
| Baseline — Somewhat Worse | 0 |
| Baseline — No Change | 9 |
| Baseline — Somewhat Improved | 0 |
| Baseline — Improved | 0 |
| Baseline — Very much Improved | 0 |
| Week 4 — Very Much Worse | 0 |
| Week 4 — Worse | 0 |
| Week 4 — Somewhat Worse | 0 |
| Week 4 — No Change | 3 |
| Week 4 — Somewhat Improved | 2 |
| Week 4 — Improved | 4 |
| Week 4 — Very much Improved | 0 |
| Week 8 — Very Much Worse | 0 |
| Week 8 — Worse | 0 |
| Week 8 — Somewhat Worse | 0 |
| Week 8 — No Change | 2 |
| Week 8 — Somewhat Improved | 2 |
| Week 8 — Improved | 3 |
| Week 8 — Very much Improved | 0 |
| Week 12 — Very Much Worse | 0 |
| Week 12 — Worse | 0 |
| Week 12 — Somewhat Worse | 0 |
| Week 12 — No Change | 2 |
| Week 12 — Somewhat Improved | 2 |
| Week 12 — Improved | 3 |
| Week 12 — Very much Improved | 0 |
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.
| Scores on a scale | Parsaclisib |
|---|---|
| Change in Score at Week 4 | -2.6 ± 4.03 |
| Change in Score at Week 8 | -1.9 ± 2.79 |
| Change in Score at Week 12 | -1.7 ± 2.87 |
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.
| Index | Parsaclisib |
|---|---|
| Change in Functional Index at Week 4 | 1.8 ± 3.19 |
| Change in Functional Index at Week 8 | 2.8 ± 4.76 |
| Change in Functional Index at Week 12 | 1.3 ± 1.83 |
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.
| Scores on a scale | Parsaclisib |
|---|---|
| Change in EQ5D at week 4 | 7.2 ± 17.34 |
| Change in EQ5D at week 8 | 0.7 ± 28.05 |
| Change in EQ5D at week 12 | -6.4 ± 22.49 |
Defined as change and percent change in stimulated and unstimulated whole salivary flow from baseline
| Percentage Change | Parsaclisib |
|---|---|
| Percent change in stimulated salivary flow Week 4 | 17.57 ± 36.225 |
| Percent change in stimulated salivary flow Week 8 | -10.59 ± 32.874 |
| Percent change in stimulated salivary flow Week 12 | -16.07 ± 41.754 |
| Percent change in unstimulated salivary flow Week 4 | 228.10 ± 282.634 |
| Percent change in unstimulated salivary flow Week 8 | 307.56 ± 601.557 |
| Percent change in unstimulated salivary flow Week 12 | 281.12 ± 541.333 |
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 | Parsaclisib |
|---|---|
| Percent Change at Week 4 | 1.8 ± 28.13 |
| Percent Change at Week 8 | -5.2 ± 24.09 |
| Percent Change at Week 12 | -32.1 ± 25.70 |
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 | Parsaclisib |
|---|---|
| Percent Change at Week 4 | -24.4 ± 40.36 |
| Percent Change at Week 8 | -29.0 ± 28.27 |
| Percent Change at Week 12 | -25.8 ± 30.52 |
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 | Parsaclisib |
|---|---|
| Percent change in Symptom Score for eye dryness at Week 4 | -33.2 ± 35.29 |
| Percent change in Symptom Score for eye dryness at Week 8 | -39.3 ± 23.89 |
| Percent change in Symptom Score for eye dryness at Week 12 | -40.9 ± 39.09 |
| Percent change in Symptom Score for mouth dryness at Week 4 | -37.7 ± 37.56 |
| Percent change in Symptom Score for mouth dryness at Week 8 | -28.0 ± 32.97 |
| Percent change in Symptom Score for mouth dryness at Week 12 | -50.9 ± 45.88 |
| Percent change in Symptom Score for vaginal dryness at Week 4 | -24.0 ± 49.18 |
| Percent change in Symptom Score for vaginal dryness at Week 8 | -54.2 ± 51.59 |
| Percent change in Symptom Score for vaginal dryness at Week 12 | -49.0 ± 42.54 |
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.
| Percentage Change | Parsaclisib |
|---|---|
| Percent change in Score at Week 4 | -11.1 ± 21.87 |
| Percent change in Score at Week 8 | -7.5 ± 13.17 |
| Percent change in Score at Week 12 | -6.4 ± 13.16 |
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 | Parsaclisib |
|---|---|
| Percent change in Functional Index at Week 4 | 39.0 ± 94.61 |
| Percent change in Functional Index at Week 8 | 8.7 ± 31.63 |
| Percent change in Functional Index at Week 12 | 23.3 ± 30.08 |
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.
| Percentage Change | Parsaclisib |
|---|---|
| Percent Change in EQ5D at week 4 | 21.1 ± 55.37 |
| Percent Change in EQ5D at week 8 | 11.9 ± 62.91 |
| Percent Change in EQ5D at week 12 | -8.9 ± 49.54 |
Collected over Up to 21 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parsaclisib | 0/10 (0%) | 0/10 (0%) | 4/10 (40%) |
| Event | Parsaclisib |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/10 |
| Dental cariesGastrointestinal disorders | 1/10 |
| FallInjury, poisoning and procedural complications | 1/10 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 1/10 |
| Musculoskeletal chest painMusculoskeletal and connective tissue disorders | 1/10 |
| NauseaGastrointestinal disorders | 1/10 |
| NeurodermatitisSkin and subcutaneous tissue disorders | 1/10 |
| Oral candidiasisInfections and infestations | 1/10 |
| PruritusSkin and subcutaneous tissue disorders | 1/10 |
| ToothacheGastrointestinal disorders | 1/10 |
| Age, Continuous(Years) | Parsaclisib |
|---|---|
| Mean | 54.1 ± 13.47 |
| Sex: Female, Male(Participants) | Parsaclisib |
|---|---|
| Female | 9 |
| Male | 1 |
| Race/Ethnicity, Customized(Participants) | Parsaclisib |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 9 |
| Race/Ethnicity, Customized(Participants) | Parsaclisib |
|---|---|
| White/Caucasian | 4 |
| Black/African-American | 6 |
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