Phase 2 N=20 Treatment

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

Prurigo Nodularis · Pruritus · Chronic Pruritus · Chronic Prurigo · Skin Diseases

Bottom Line

View on ClinicalTrials.gov: NCT05038982 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12 — -78.26; -53.66 percent change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Abrocitinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12	-78.26; -53.66	<0.001 sig
SECONDARY Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12	8; 6	—
SECONDARY Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12	18.60; 17.40; 9.20; 11.30	0.002 sig
SECONDARY Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12	19.0; 9.60; 8.90; 4.90	0.002 sig
SECONDARY Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12	14.76; 9.32	0.0078 sig
SECONDARY Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12	53.76; 45.60; 41.03; 35.72	0.0098 sig
SECONDARY Number of Nodules at Baseline and Week 12	14.90; 4.70	0.002 sig
SECONDARY Prurigo Nodule Severity at Baseline and Week 12	3.60; 2.50	0.0078 sig
SECONDARY Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12	0.60; 0.74; 0.75; 0.86	0.0391 sig
SECONDARY Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12	6.90; 4.20; 3.30; 3.10	0.0684
SECONDARY Anxiety as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12	6.60; 4.30; 5.90; 4.30	0.207
SECONDARY Sleep Disturbance as Assessed by the SD-NRS at Baseline and Week 12	7.20; 5.10; 2.40; 2.80	0.0039 sig
SECONDARY Itch Intensity in Patients With Underlying Atopy at Baseline and Week 12	9.67; 0.67	0.0003 sig
SECONDARY Itch Intensity in Patients Without Underlying Atopy at Baseline and Week 12	9.00; 2.57	<0.0001 sig
SECONDARY Itch Intensity in CPUO Patients With High Eosinophilia at Baseline and Week 12	—	—
SECONDARY Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12	0.35; 0.27; -0.085; 0.045; -0.31; -0.36	<0.0001 sig
SECONDARY Systemic Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12	—	—

Summary

The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe pruritus.

Eligibility Criteria

Inclusion Criteria

Males or female participants between ages 18-80 years at time of signing informed consent
A clinical diagnosis of prurigo nodularis, defined by the presence of at least 10 pruritic nodules on at least 2 different anatomic locations (with each arm, leg, and anterior and posterior trunk considered distinct anatomic locations)

Subject has ongoing chronic pruritus of unknown origin, which must be present on multiple segments on the body. CPUO patients must not have known dermatologic or systemic conditions, that in the opinion of the investigator, are the cause of patient's pruritus
Subject has moderate to severe pruritus, defined as average peak pruritus numeric rating scale - (PP-NRS) > 7 (range 0-10, higher score indicating greater degree of pruritus severity) in the 7 days prior to the Screening Visit.
Female participants are eligible for the study if they are not pregnant, planning to become pregnant or breastfeeding during the study or not a woman of child bearing potential (WOCBP)

Exclusion Criteria

Infected with hepatitis B or hepatitis C viruses.
Infected with Herpes Simplex or Herpes zoster.
Positive HIV serology at screening,
Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
History of lymphoproliferative disease, or active primary or recurrent malignancy
History of recurrent (≥ 2) venous thromboembolism (VTE) or (DVT/PE) - deep vein thrombosis and pulmonary embolism
Untreated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy
Have received any of the following treatment regiments specified in the timeframes outlined below:
Within 6 months of first dose of study drug: Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg)
Within 12 weeks of first dose of study drug: Any studies with Janus kinase (JAK) inhibitors; Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-interferon (IFN) therapy)
Within 8 weeks of first dose of study drug: Other biologics
Within 6 weeks: Have been vaccinated with live or attenuated live vaccine.
Within 4 weeks: Participation in other studies involving investigational drug(s)
Within 4 weeks: Use of oral immune suppressants; systemic immunosuppressive therapies, neuromodulatory therapies, Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
Within 1 week of first dose of study drug: Topical treatments that could affect PN; Herbal medications with unknown properties or known beneficial effects for PN.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05038982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.