Trial Outcomes & Findings for A Study of INCB050465 in Primary Sjögren's Syndrome (NCT NCT03627065)

NCT ID: NCT03627065

Last Updated: 2021-08-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Week 4 and Week 12
• Results posted on: 2021-08-13

Participant Flow

Approximately 12 participants were planned. Ten participants were enrolled and analyzed for efficacy and safety.

Ten participants were enrolled and treated. Seven participants completed treatment. Three participants discontinued treatment and withdrew from the study.

Participant milestones

Measure	Parsaclisib parsaclisib was administered orally once a day.
Overall Study STARTED	10
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Parsaclisib parsaclisib was administered orally once a day.
Overall Study Study Terminated by sponsor	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Study of INCB050465 in Primary Sjögren's Syndrome

Baseline characteristics by cohort

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Age, Continuous	54.1 Years STANDARD_DEVIATION 13.47 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	9 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	4 Participants n=5 Participants
Race/Ethnicity, Customized Black/African-American	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
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
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 outcome

Timeframe: 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.

To assess the impact of parsaclisib on salivary CXCL13.

Outcome measures

Measure	Parsaclisib n=2 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Change From Baseline in Salivary CXCL13 Levels Week 4	0.96 L/h Standard Deviation 0.1
Change From Baseline in Salivary CXCL13 Levels Week 12	1.98 L/h Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Number of Participants With Treatment-emergent Adverse Events	4 Participants

SECONDARY outcome

Timeframe: 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.

Defined as change in stimulated and unstimulated whole salivary flow from baseline

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Change in Whole Salivary Flow Mean change in unstimulated salivary flow Week 8	0.07 g/min Standard Deviation 0.109
Change in Whole Salivary Flow Mean change in stimulated salivary flow Week 4	0.07 g/min Standard Deviation 0.152
Change in Whole Salivary Flow Mean change in stimulated salivary flow Week 8	-0.05 g/min Standard Deviation 0.129
Change in Whole Salivary Flow Mean change in stimulated salivary flow Week 12	-0.05 g/min Standard Deviation 0.144
Change in Whole Salivary Flow Mean change in unstimulated salivary flow Week 4	0.03 g/min Standard Deviation 0.046
Change in Whole Salivary Flow Mean change in unstimulated salivary flow Week 12	0.04 g/min Standard Deviation 0.082

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.

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).

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Change in EULAR Sjögren's Syndrome Disease Activity Index Mean Change at Week 4	-0.3 Index Standard Deviation 2.92
Change in EULAR Sjögren's Syndrome Disease Activity Index Mean Change at Week 8	-2.0 Index Standard Deviation 4.12
Change in EULAR Sjögren's Syndrome Disease Activity Index Mean Change at Week 12	-5.3 Index Standard Deviation 4.15

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=9 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Change in EULAR Sjögren's Syndrome Patient Reported Index Mean Change at Week 4	-1.9 Index Standard Deviation 2.26
Change in EULAR Sjögren's Syndrome Patient Reported Index Mean Change at Week 8	-2.0 Index Standard Deviation 1.93
Change in EULAR Sjögren's Syndrome Patient Reported Index Mean Change at Week 12	-1.8 Index Standard Deviation 1.98

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
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
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
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
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
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
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
Change in Symptom Scores for Dryness Change in Symptom Score for vaginal dryness at Week 4	-1.3 Scores on a scale Standard Deviation 3.20
Change in Symptom Scores for Dryness Change in Symptom Score for vaginal dryness at Week 8	-2.3 Scores on a scale Standard Deviation 3.50
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 outcome

Timeframe: 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.

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

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Patient Global Impression of Change Questionnaire Baseline · Very Much Worse	0 Participants
Patient Global Impression of Change Questionnaire Baseline · Worse	0 Participants
Patient Global Impression of Change Questionnaire Baseline · Somewhat Worse	0 Participants
Patient Global Impression of Change Questionnaire Baseline · No Change	9 Participants
Patient Global Impression of Change Questionnaire Baseline · Somewhat Improved	0 Participants
Patient Global Impression of Change Questionnaire Baseline · Improved	0 Participants
Patient Global Impression of Change Questionnaire Baseline · Very much Improved	0 Participants
Patient Global Impression of Change Questionnaire Week 4 · Very Much Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 4 · Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 4 · Somewhat Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 4 · No Change	3 Participants
Patient Global Impression of Change Questionnaire Week 4 · Somewhat Improved	2 Participants
Patient Global Impression of Change Questionnaire Week 4 · Improved	4 Participants
Patient Global Impression of Change Questionnaire Week 4 · Very much Improved	0 Participants
Patient Global Impression of Change Questionnaire Week 8 · Very Much Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 8 · Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 8 · Somewhat Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 8 · No Change	2 Participants
Patient Global Impression of Change Questionnaire Week 8 · Somewhat Improved	2 Participants
Patient Global Impression of Change Questionnaire Week 8 · Improved	3 Participants
Patient Global Impression of Change Questionnaire Week 8 · Very much Improved	0 Participants
Patient Global Impression of Change Questionnaire Week 12 · Very Much Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 12 · Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 12 · Somewhat Worse	0 Participants
Patient Global Impression of Change Questionnaire Week 12 · No Change	2 Participants
Patient Global Impression of Change Questionnaire Week 12 · Somewhat Improved	2 Participants
Patient Global Impression of Change Questionnaire Week 12 · Improved	3 Participants
Patient Global Impression of Change Questionnaire Week 12 · Very much Improved	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Change in PROMIS Fatigue Short Form Change in Score at Week 4	-2.6 Scores on a scale Standard Deviation 4.03
Change in PROMIS Fatigue Short Form Change in Score at Week 8	-1.9 Scores on a scale Standard Deviation 2.79
Change in PROMIS Fatigue Short Form Change in Score at Week 12	-1.7 Scores on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=9 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Female Participants Only : Change in Female Sexual Function Index Change in Functional Index at Week 4	1.8 Index Standard Deviation 3.19
Female Participants Only : Change in Female Sexual Function Index Change in Functional Index at Week 8	2.8 Index Standard Deviation 4.76
Female Participants Only : Change in Female Sexual Function Index Change in Functional Index at Week 12	1.3 Index Standard Deviation 1.83

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
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
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
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 outcome

Timeframe: 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.

Defined as change and percent change in stimulated and unstimulated whole salivary flow from baseline

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Percentage Change in Whole Salivary Flow Percent change in stimulated salivary flow Week 4	17.57 Percentage Change Standard Deviation 36.225
Percentage Change in Whole Salivary Flow Percent change in stimulated salivary flow Week 8	-10.59 Percentage Change Standard Deviation 32.874
Percentage Change in Whole Salivary Flow Percent change in stimulated salivary flow Week 12	-16.07 Percentage Change Standard Deviation 41.754
Percentage Change in Whole Salivary Flow Percent change in unstimulated salivary flow Week 4	228.10 Percentage Change Standard Deviation 282.634
Percentage Change in Whole Salivary Flow Percent change in unstimulated salivary flow Week 8	307.56 Percentage Change Standard Deviation 601.557
Percentage Change in Whole Salivary Flow Percent change in unstimulated salivary flow Week 12	281.12 Percentage Change Standard Deviation 541.333

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug.

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).

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index Percent Change at Week 4	1.8 Percentage Change Standard Deviation 28.13
Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index Percent Change at Week 8	-5.2 Percentage Change Standard Deviation 24.09
Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index Percent Change at Week 12	-32.1 Percentage Change Standard Deviation 25.70

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index Percent Change at Week 4	-24.4 Percentage Change Standard Deviation 40.36
Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index Percent Change at Week 8	-29.0 Percentage Change Standard Deviation 28.27
Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index Percent Change at Week 12	-25.8 Percentage Change Standard Deviation 30.52

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
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
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
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
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
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
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
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
Percentage Change in PROMIS Fatigue Short Form Percent change in Score at Week 4	-11.1 Percentage Change Standard Deviation 21.87
Percentage Change in PROMIS Fatigue Short Form Percent change in Score at Week 8	-7.5 Percentage Change Standard Deviation 13.17
Percentage Change in PROMIS Fatigue Short Form Percent change in Score at Week 12	-6.4 Percentage Change Standard Deviation 13.16

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=9 Participants parsaclisib was administered orally once a day for up to 12 weeks.
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Parsaclisib n=10 Participants parsaclisib was administered orally once a day for up to 12 weeks.
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
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
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

Adverse Events

Parsaclisib

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Parsaclisib n=10 participants at risk parsaclisib was administered orally once a day.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • Up to 21 weeks
Gastrointestinal disorders Dental caries	10.0% 1/10 • Number of events 1 • Up to 21 weeks
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Number of events 1 • Up to 21 weeks
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 1/10 • Number of events 1 • Up to 21 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	10.0% 1/10 • Number of events 1 • Up to 21 weeks
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • Up to 21 weeks
Skin and subcutaneous tissue disorders Neurodermatitis	10.0% 1/10 • Number of events 1 • Up to 21 weeks
Infections and infestations Oral candidiasis	10.0% 1/10 • Number of events 2 • Up to 21 weeks
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Number of events 1 • Up to 21 weeks
Gastrointestinal disorders Toothache	10.0% 1/10 • Number of events 1 • Up to 21 weeks

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Clinical Study Agreement
• Publication restrictions are in place

Restriction type: OTHER