Trial Outcomes & Findings for Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin (NCT NCT05038982)

NCT ID: NCT05038982

Last Updated: 2023-07-03

Results Overview

Percent change in weekly average PP-NRS at Week 12. PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 12 weeks
• Results posted on: 2023-07-03

Participant Flow

Patients were recruited by referral or at Johns Hopkins Dermatology clinic between September 2021 and March 2022

25 patients were assessed for eligibility and screening; four patients failed screening due to laboratory values or presence of uncontrolled disease. One patient left the study voluntarily. Therefore, 20 patients were enrolled in the study

Participant milestones

Measure	Prurigo Nodularis Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Overall Study STARTED	10	10
Overall Study End of Intervention Period. Week 12: Per Protocol Population	10	10
Overall Study Follow-up Period (4 Weeks)	10	8
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Prurigo Nodularis Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin

Baseline characteristics by cohort

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Total n=20 Participants Total of all reporting groups
Age, Continuous	58.6 years STANDARD_DEVIATION 13.1 • n=5 Participants	70.7 years STANDARD_DEVIATION 5.6 • n=7 Participants	64.7 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Percent change in weekly average PP-NRS at Week 12. PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12	-78.26 percent change Interval -118.48 to -38.09	-53.66 percent change Interval -98.76 to -8.55

SECONDARY outcome

Timeframe: Up to 12 weeks

Number of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 12. The PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Assess itch severity as assessed by 5-D pruritus scale. The 5-D pruritus scale scores pruritus over the past 2 weeks along 5 dimensions: duration, degree, direction, disability and distribution. Duration, degree and direction are scored from 1 to 5, with "1" indicating better control and resolution of symptoms, and "5" indicating increased intensity, severity and worsening. Disability is assessed in Leisure/Social, housework/errands, and work/school with scores ranging from N/A, and 1-5, with "1" indicating that itch never affects the activity, and "5" meaning that itch always affects this activity. The scores of each of the 5 domains are achieved separately and then summed together to obtain a total score. Scores can range between 5 no pruritus, and 25 most severe pruritus.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12 Week 0	18.60 score on a scale Interval 14.98 to 22.22	17.40 score on a scale Interval 14.89 to 19.91
Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12 Week 12	9.20 score on a scale Interval 7.59 to 10.81	11.30 score on a scale Interval 6.4 to 16.2

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Quality of life as assessed by the Dermatology Quality of Life Index (DLQI). The DLQI is 10 questions used to assess impact of skin disease. Scores range from 0-30, with "0" corresponding to best quality of life, and "30" corresponding to worst quality of life.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12 Week 0	19.0 score on a scale Interval 13.3 to 24.7	9.60 score on a scale Interval 6.4 to 12.8
Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12 Week 12	8.90 score on a scale Interval 4.31 to 13.49	4.90 score on a scale Interval 2.68 to 7.12

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Population: Since this is an assessment for Prurigo Nodularis, only Prurigo Nodularis patients were assessed for this outcome. Data was not collected for patient with Chronic Pruritus of Unknown Origin

Pruriginous lesions as assessed by the Prurigo Activity Score (PAS). The PAS is a 7-item questionnaire that assesses the number, distribution and activity of pruriginous lesions. The score is calculated via summation of the scoring values, added up with 123 and afterwards divided by 10. This results in a range of values from 1.3 to 21.3.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12 Week 0	14.76 score on a scale Interval 13.04 to 16.48	—
Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12 Week 12	9.32 score on a scale Interval 6.57 to 12.07	—

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Itch-scratching behavior as assessed by Patient Reported Outcomes Measurement Information System (PROMIS®) Itch Questionnaire (PIQ) T-Score: Scratching. The PIQ T-Score: Scratching, is comprised of 5 questions to assess Itch-Scratching Behavior over the past 7 days. Scores for each question range from 1-5, Score range of 5-25 with scores of "1" indicating less scratching behavior and scores of "5" indicating the greatest scratching behavior.

A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Itch, a T-score of 60 is one SD worse than average. By comparison, an Itch T-score of 40 is one SD better than average

For PROMIS, the T-scores have a mean (SD) of 50 (10) for adults in the US experiencing itch for any reason.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12 Week 0	53.76 T-score Interval 48.74 to 58.78	45.60 T-score Interval 41.57 to 49.63
Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12 Week 12	41.03 T-score Interval 32.67 to 49.39	35.72 T-score Interval 30.28 to 41.16

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Population: Assessed only in participants with nodules (Prurigo Nodularis arm). Since this is an assessment for Prurigo Nodularis, only Prurigo Nodularis patients were assessed for this outcome. Data was not collected for patient with Chronic Pruritus of Unknown Origin.

Number of baseline prurigo nodules over time. As part of the Prurigo Activity Score, lesions are counted in a representative body region. Lesion count within the representative area at Week 0 was compared to lesion count in the representative area at Week 12.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Number of Nodules at Baseline and Week 12 Week 0	14.90 Lesion count Interval 9.21 to 20.59	—
Number of Nodules at Baseline and Week 12 Week 12	4.70 Lesion count Interval 2.59 to 6.81	—

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Population: Assessed only in participants with nodules (Prurigo Nodularis arm). Since this is an assessment for Prurigo Nodularis, only Prurigo Nodularis patients were assessed for this outcome. Data was not collected for patient with Chronic Pruritus of Unknown Origin

Prurigo nodule severity using the Investigator's Global Assessment (IGA). The IGA is a physician scale assessing the number of nodules a Prurigo Nodularis (PN) patient has. Patients receive a score between 0 and 4, where "0" is clear: "No prurigo nodules. Post-inflammatory hypo/hyper pigmentation may be present". Grades of "4" are severe: "Abundant prurigo nodules. Marked nodule elevation."

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Prurigo Nodule Severity at Baseline and Week 12 Week 0	3.60 score on a scale Interval 3.23 to 3.97	—
Prurigo Nodule Severity at Baseline and Week 12 Week 12	2.50 score on a scale Interval 1.99 to 3.01	—

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Quality of life as assessed by EuroQoL 5-Dimension (EQ-5D). The 3 level version of the EQ-5D (EQ-5D-3L) assesses degree of debilitation in 5 major aspects of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three possible answers. These answers equate to: "No problems" or "Some/Moderate Problems" or "Severe/Extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. A unique health state is then defined by combining one level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code. A total of 243 possible health states codes is defined in this way. State 11111 indicates no problems on any of the five dimensions. The patient then rates how good or bad their health is on that day from a range from 0 the worst health you can imagine, to 100 the best health you can imagine.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12 Week 0	0.60 score on a scale Interval 0.33 to 0.87	0.74 score on a scale Interval 0.55 to 0.93
Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12 Week 12	0.75 score on a scale Interval 0.52 to 0.99	0.86 score on a scale Interval 0.67 to 1.05

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Depression as assessed by The Hospital Anxiety and Depression Scale (HADS), has 7 items relating to depression. Each item scored from 0-3 with higher scores indicating higher depression. Total score range 0-21.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12 Week 0	6.90 score on a scale Interval 3.42 to 10.38	4.20 score on a scale Interval 0.93 to 7.47
Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12 Week 12	3.30 score on a scale Interval 0.398 to 6.202	3.10 score on a scale Interval 0.31 to 5.89

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Anxiety as assessed by The Hospital Anxiety and Depression Scale (HADS), has 7 items relating to anxiety. Each item scored from 0-3 with higher scores indicating higher anxiety. Total score range 0-21.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Anxiety as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12 Week 0	6.60 score on a scale Interval 2.62 to 10.58	4.30 score on a scale Interval 0.061 to 8.54
Anxiety as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12 Week 12	5.90 score on a scale Interval 2.61 to 9.2	4.30 score on a scale Interval 0.27 to 8.33

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Average sleep disturbance from Week 0 and Week 12 as assessed by (SD) NRS. The SD-NRS is an 11-point scale (0 -10) with higher scores indicating greater sleep disturbance.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Sleep Disturbance as Assessed by the SD-NRS at Baseline and Week 12 Week 0	7.20 score on a scale Interval 5.52 to 8.88	5.10 score on a scale Interval 2.66 to 7.54
Sleep Disturbance as Assessed by the SD-NRS at Baseline and Week 12 Week 12	2.40 score on a scale Interval -0.06 to 4.86	2.80 score on a scale Interval -0.017 to 5.62

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Population: Prurigo Nodularis patients with underlying atopy

Itch intensity as assessed by PP-NRS in Prurigo Nodularis patients with underlying atopy. The PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable. Atopy defined as a binary variable where patients have 2 out of 3: underlying history of atopic dermatitis, history of seasonal allergies, or asthma.

Outcome measures

Measure	Prurigo Nodularis n=3 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Itch Intensity in Patients With Underlying Atopy at Baseline and Week 12 Week 0	9.67 score on a scale Interval 8.23 to 11.1	—
Itch Intensity in Patients With Underlying Atopy at Baseline and Week 12 Week 12	0.67 score on a scale Interval -2.2 to 3.54	—

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Population: Prurigo Nodularis patients without underlying atopy

Itch intensity as assessed by PP-NRS in Prurigo Nodularis patients without underlying atopy. The PP-NRS is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable. Atopy is defined as a binary variable where patients have 2 out of 3: underlying history of atopic dermatitis, history of seasonal allergies, or asthma.

Outcome measures

Measure	Prurigo Nodularis n=7 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Itch Intensity in Patients Without Underlying Atopy at Baseline and Week 12 Week 0	9.00 score on a scale Interval 7.93 to 10.07	—
Itch Intensity in Patients Without Underlying Atopy at Baseline and Week 12 Week 12	2.57 score on a scale Interval 0.075 to 5.07	—

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Population: Data not collected. None of the CPUO subjects met the pre-defined criteria for eosinophilia.

Itch intensity as measured by PP-NRS in CPUO patients with high eosinophilia (greater than 500 eosinophils per micro-liter of blood). The PP-NRS is an 11-point single self-report item on a scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week 0) and 12 weeks

Population: PN and CPUO patients had biopsies collected at Week 0 and at Week 12. PN patients had two biopsies collected: a lesional site and a non-lesional biopsy close by for comparison. The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions.

Lesional and non-lesional skin biopsies will be compared for Type 1/2/17/22 T Helper (Th) Th1/Th2/Th17/Th22 polarization before and after treatment. PN and CPUO patients had biopsies collected at Week 0 and at Week 12. PN patients had two biopsies collected: a lesional site and a non-lesional biopsy close by for comparison. The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions.

CPUO will be compared from week 0 to week 12. PN will compare Lesional to non Lesional at Week 0. PN will compare Lesional to Non Lesional at Week 12.

GSVA will compare gene set enrichment scores as a function of gene pathway expression which range from -1 to 1. Lower scores indicate down regulation of the gene set, and higher scores indicate up regulation.

Outcome measures

Measure	Prurigo Nodularis n=10 Participants Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 Participants Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th2 Lesional Week 0	0.22 score on a scale Interval -0.047 to 0.49	0.17 score on a scale Interval 0.016 to 0.32
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th22 Lesional Week 12	0.25 score on a scale Interval -0.06 to 0.55	-0.15 score on a scale Interval -0.34 to 0.034
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th1 Lesional Week 0	0.35 score on a scale Interval 0.0035 to 0.69	0.27 score on a scale Interval 0.076 to 0.46
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th1 Non Lesional Week 0	-0.085 score on a scale Interval -0.31 to 0.14	—
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th1 Lesional Week 12	0.045 score on a scale Interval -0.31 to 0.4	-0.31 score on a scale Interval -0.49 to -0.14
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th1 Non Lesional Week 12	-0.36 score on a scale Interval -0.7 to -0.021	—
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th2 Non Lesional Week 0	-0.11 score on a scale Interval -0.31 to 0.086	—
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th2 Lesional Week 12	0.10 score on a scale Interval -0.16 to 0.37	-0.20 score on a scale Interval -0.32 to -0.083
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th2 Non Lesional Week 12	-0.18 score on a scale Interval -0.44 to 0.08	—
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th17 Lesional Week 0	0.29 score on a scale Interval 0.048 to 0.52	0.12 score on a scale Interval -0.1 to 0.33
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th17 Non Lesional Week 0	-0.29 score on a scale Interval -0.52 to -0.062	—
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th17 Lesional Week 12	0.20 score on a scale Interval -0.16 to 0.57	-0.099 score on a scale Interval -0.25 to 0.05
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th17 Non Lesional Week 12	-0.083 score on a scale Interval -0.45 to 0.29	—
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th22 Lesional Week 0	0.23 score on a scale Interval -0.06 to 0.52	0.23 score on a scale Interval 0.048 to 0.42
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th22 Non Lesional Week 0	-0.29 score on a scale Interval -0.5 to -0.071	—
Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12 Th22 Non Lesional Week 12	-0.16 score on a scale Interval -0.49 to 0.17	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: This outcome was not assessed. Data was not collected.

Plasma cytokines will be analyzed for TH1/Th2/Th17/Th22 polarization before and after treatment. This outcome was posted in error. It is not appropriate to perform GSVA of plasma cytokines. It is best practice to limit GSVA to RNASeq.

Outcome measures

Outcome data not reported

Adverse Events

Prurigo Nodularis

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Chronic Pruritus of Unknown Origin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prurigo Nodularis n=10 participants at risk Prurigo Nodularis (PN) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.	Chronic Pruritus of Unknown Origin n=10 participants at risk Chronic Pruritus of Unknown Origin (CPUO) patients only: Study Design: Subjects meeting study criteria will undergo a 4-week washout period of other therapies that could impact pruritus through the end of the study (including antihistamines, topical steroids, systemic antipruritic therapies or immunosuppressants). Abrocitinib: During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.	0.00% 0/10 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.	0.00% 0/10 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.
Skin and subcutaneous tissue disorders Folliculitis	0.00% 0/10 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.	10.0% 1/10 • Number of events 1 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.
Skin and subcutaneous tissue disorders Acneiform Eruption	10.0% 1/10 • Number of events 1 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.	10.0% 1/10 • Number of events 1 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.
Infections and infestations Sore throat	10.0% 1/10 • Number of events 1 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.	0.00% 0/10 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.
Infections and infestations Herpes Labialis	0.00% 0/10 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.	10.0% 1/10 • Number of events 1 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.
Infections and infestations Nasal Congestion	10.0% 1/10 • Number of events 1 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.	0.00% 0/10 • From the first date of abrocitinib administration to the last date of abrocitinib administration + 4 week follow up, up to 16 weeks total.

Additional Information

Shawn Kwatra

Johns Hopkins University

Phone: 410-502-7546

Email: skwatra1@jhmi.edu

Results disclosure agreements

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