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

NCT ID: NCT05038982

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-07-11

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Abrocitinib

Intervention Type: 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

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).

Group Type: EXPERIMENTAL

Abrocitinib

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shawn G Kwatra, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38837144 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00262268

Identifier Type: -

Identifier Source: org_study_id