Clinical trial NCT05038982: Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
Official title: Efficacy, Safety, and Tolerability of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prurigo Nodularis
Pruritus
Chronic Pruritus
Chronic Prurigo
Skin Diseases
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Pfizer
First posted: 2021-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-randomized study with two arms conducted in parallel: an arm of 10 Prurigo Nodularis (PN) patients, and an arm of 10 Chronic pruritus of unknown origin (CPUO) patients.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a trial to assess the efficacy of Abrocitinib as a therapeutic for Prurigo Nodularis (PN) and Chronic Pruritus of Unknown Origin (CPUO). The study will consist of a 4-week Screening period, a 12-week treatment period and then a 4-week follow up period. The arms will run in parallel and patients will take 200 mg oral Abrocitinib daily for the duration of the 12-week treatment period.

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)

OR

* 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.

Primary outcomes:
measure: Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12
timeFrame: Up to 12 weeks
measure: Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Number of Nodules at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Prurigo Nodule Severity at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Quality of Life as Assessed by the EuroQoL 5-Dimension at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Depression as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Anxiety as Assessed by The Hospital Anxiety and Depression Scale at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Sleep Disturbance as Assessed by the SD-NRS at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Itch Intensity in Patients With Underlying Atopy at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Itch Intensity in Patients Without Underlying Atopy at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Itch Intensity in CPUO Patients With High Eosinophilia at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12
timeFrame: Baseline (week 0) and 12 weeks
measure: Systemic Biomarker Analysis - Gene Set Variation Analysis (GSVA), at Baseline and Week 12
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Shawn G Kwatra, MD
role: PRINCIPAL_INVESTIGATOR
References: