Trial · NCT05038982

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

NCT05038982, Phase 2, Completed, Johns Hopkins University; results first posted 2023-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin. Trials, record NCT05038982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05038982

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
NCT number: NCT05038982
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Prurigo Nodularis, Pruritus, Chronic Pruritus, Chronic Prurigo, Skin Diseases
Interventions: Abrocitinib
First posted: 2021-09-09
Last updated: 2023-07-03
Results first posted: 2023-07-03

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12	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.
Secondary	Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12	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.
Secondary	Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12	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.
Secondary	Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12	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.
Secondary	Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12	Baseline (week 0) and 12 weeks	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.
Secondary	Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12	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.
Secondary	Number of Nodules at Baseline and Week 12	Baseline (week 0) and 12 weeks	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.
Secondary	Prurigo Nodule Severity at Baseline and Week 12	Baseline (week 0) and 12 weeks	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."
Secondary	Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12	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.
Secondary	Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12	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.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12	Up to 12 weeks		percent change	MEAN
SECONDARY	Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12	Up to 12 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12	Baseline (week 0) and 12 weeks		score on a scale	MEAN
SECONDARY	Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12	Baseline (week 0) and 12 weeks		score on a scale	MEAN
SECONDARY	Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12	Baseline (week 0) and 12 weeks	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	score on a scale	MEAN
SECONDARY	Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12	Baseline (week 0) and 12 weeks		T-score	MEAN
SECONDARY	Number of Nodules at Baseline and Week 12	Baseline (week 0) and 12 weeks	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.	Lesion count	MEAN
SECONDARY	Prurigo Nodule Severity at Baseline and Week 12	Baseline (week 0) and 12 weeks	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	score on a scale	MEAN
SECONDARY	Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12	Baseline (week 0) and 12 weeks		score on a scale	MEAN
SECONDARY	Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12	Baseline (week 0) and 12 weeks		score on a scale	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group66

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12	Prurigo Nodularis		-78.26	95% Confidence Interval -118.48 to -38.09	percent change
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12	Chronic Pruritus of Unknown Origin		-53.66	95% Confidence Interval -98.76 to -8.55	percent change
Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12	Prurigo Nodularis		8		Participants
Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12	Chronic Pruritus of Unknown Origin		6		Participants
Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12	Prurigo Nodularis	Week 0	18.60	95% Confidence Interval 14.98 to 22.22	score on a scale
Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12	Chronic Pruritus of Unknown Origin	Week 0	17.40	95% Confidence Interval 14.89 to 19.91	score on a scale
Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12	Prurigo Nodularis	Week 12	9.20	95% Confidence Interval 7.59 to 10.81	score on a scale
Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12	Chronic Pruritus of Unknown Origin	Week 12	11.30	95% Confidence Interval 6.40 to 16.20	score on a scale
Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12	Prurigo Nodularis	Week 0	19.0	95% Confidence Interval 13.30 to 24.70	score on a scale
Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12	Chronic Pruritus of Unknown Origin	Week 0	9.60	95% Confidence Interval 6.40 to 12.80	score on a scale

1 to 10 of 66Source ClinicalTrials.gov

See all 66 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Prurigo Nodularis	10
Overall Study	STARTED	Chronic Pruritus of Unknown Origin	10
Overall Study	End of Intervention Period. Week 12: Per Protocol Population	Prurigo Nodularis	10
Overall Study	End of Intervention Period. Week 12: Per Protocol Population	Chronic Pruritus of Unknown Origin	10
Overall Study	Follow-up Period (4 Weeks)	Prurigo Nodularis	10
Overall Study	Follow-up Period (4 Weeks)	Chronic Pruritus of Unknown Origin	8
Overall Study	COMPLETED	Prurigo Nodularis	10
Overall Study	COMPLETED	Chronic Pruritus of Unknown Origin	8
Overall Study	NOT COMPLETED	Prurigo Nodularis	0
Overall Study	NOT COMPLETED	Chronic Pruritus of Unknown Origin	2

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Prurigo Nodularis	1	10	1
other	Headache	Nervous system disorders	Chronic Pruritus of Unknown Origin	0	10	0
other	Nausea	Gastrointestinal disorders	Prurigo Nodularis	1	10	1
other	Nausea	Gastrointestinal disorders	Chronic Pruritus of Unknown Origin	0	10	0
other	Folliculitis	Skin and subcutaneous tissue disorders	Prurigo Nodularis	0	10	0
other	Folliculitis	Skin and subcutaneous tissue disorders	Chronic Pruritus of Unknown Origin	1	10	1
other	Acneiform Eruption	Skin and subcutaneous tissue disorders	Prurigo Nodularis	1	10	1
other	Acneiform Eruption	Skin and subcutaneous tissue disorders	Chronic Pruritus of Unknown Origin	1	10	1
other	Sore throat	Infections and infestations	Prurigo Nodularis	1	10	1
other	Sore throat	Infections and infestations	Chronic Pruritus of Unknown Origin	0	10	0

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prurigo Nodularis	0	10
Total, all-cause mortality	Chronic Pruritus of Unknown Origin	0	10
Total, other adverse events	Prurigo Nodularis	4	10
Total, other adverse events	Chronic Pruritus of Unknown Origin	2	10
Total, serious adverse events	Prurigo Nodularis	0	10
Total, serious adverse events	Chronic Pruritus of Unknown Origin	0	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38837144	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Prurigo Nodularis vs Chronic Pruritus of Unknown Origin: Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12	Trial comparisons
Prurigo Nodularis vs Chronic Pruritus of Unknown Origin: deaths from any cause	Trial comparisons
Prurigo Nodularis vs Chronic Pruritus of Unknown Origin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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