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

NCT05038982 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00262268
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prurigo Nodularis; Pruritus; Chronic Pruritus; Chronic Prurigo; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12

  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.

  Up to 12 weeks

Secondary Outcomes (16)

• Number of Subjects Achieving a Reduction in Weekly Average PP-NRS From Baseline to Week 12

  Up to 12 weeks

• Itch Severity Assessed by 5-D Pruritus Scale at Baseline and Week 12

  Baseline (week 0) and 12 weeks

• Quality of Life as Assessed by the Dermatology Quality of Life Index From Baseline and Week 12

  Baseline (week 0) and 12 weeks

• Pruriginous Lesions as Assessed by the Prurigo Activity Score From Baseline and Week 12

  Baseline (week 0) and 12 weeks

• Itch-scratching Behavior as Assessed by Patient Reported Outcomes Measurement Information System at Baseline and Week 12

  Baseline (week 0) and 12 weeks

Study Arms (2)

Prurigo Nodularis

EXPERIMENTAL

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).

Drug: Abrocitinib

Chronic Pruritus of Unknown Origin

EXPERIMENTAL

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).

Drug: Abrocitinib

Interventions

Abrocitinib DRUG

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; Prurigo Nodularis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Duke University: collaborator
• Pfizer: collaborator

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Kwatra SG, Bordeaux ZA, Parthasarathy V, Kollhoff AL, Alajmi A, Pritchard T, Cornman HL, Kambala A, Lee KK, Manjunath J, Ma EZ, Dillen C, Kwatra MM. Efficacy and Safety of Abrocitinib in Prurigo Nodularis and Chronic Pruritus of Unknown Origin: A Nonrandomized Controlled Trial. JAMA Dermatol. 2024 Jul 1;160(7):717-724. doi: 10.1001/jamadermatol.2024.1464.

  PMID: 38837144 DERIVED

MeSH Terms

Conditions

Pruritus; Skin Diseases

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Shawn Kwatra
• Organization: Johns Hopkins University

skwatra1@jhmi.edu

410-502-7546

Study Officials

• Shawn G Kwatra, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 9, 2021
• Study Start: September 9, 2021
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)