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

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ClinicalTrials.gov Identifier: NCT05038982
Recruitment Status : Completed
First Posted : September 9, 2021
Last Update Posted : July 27, 2022
Sponsor:
Collaborators:
Duke University
Pfizer
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Prurigo Nodularis Pruritus Chronic Pruritus Chronic Prurigo Skin Diseases Drug: Abrocitinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy, Safety, and Tolerability of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
Actual Study Start Date : September 9, 2021
Actual Primary Completion Date : July 11, 2022
Actual Study Completion Date : July 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Experimental: 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).
Drug: 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.

Experimental: 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).
Drug: 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.




Primary Outcome Measures :
  1. Percent change in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) [ Time Frame: Up to 12 weeks ]
    Change in weekly average Peak Pruritus Numeric Rating Scale (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 Outcome Measures :
  1. Percent of subjects achieving a reduction in weekly average PP-NRS [ Time Frame: Up to 12 weeks ]
    Percentage 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.

  2. Change in itch severity [ Time Frame: baseline and 12 weeks ]
    Change in 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.

  3. Change in quality of life - Dermatology [ Time Frame: baseline and 12 weeks ]
    Change in 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.

  4. Change in pruriginous lesions [ Time Frame: baseline and 12 weeks ]
    Change in 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.

  5. Change in itch-scratching behavior [ Time Frame: baseline and 12 weeks ]
    Change in itch-scratching behavior as assessed by 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.

  6. Change in Number of Nodules [ Time Frame: baseline and 12 weeks ]
    Change in number of baseline prurigo nodules over time

  7. Changes in prurigo nodule severity [ Time Frame: baseline and 12 weeks ]
    Changes in 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."

  8. Change in quality of life - debilitation [ Time Frame: baseline and 12 weeks ]
    Change in quality of life as assessed by EuroQoL 5-Dimension (EQ-5D). The 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.

  9. Change in depression [ Time Frame: baseline and 12 weeks ]
    Change in 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.

  10. Change in anxiety [ Time Frame: baseline and 12 weeks ]
    Change in anxiety as assessed by The Hospital Anxiety and Depression Scale (HADS), has 7 items relating to anxiety. Each item scored from 0-3 with higher scores indicating higher anxiety. Total score range 0-21.

  11. Percentage of subjects reporting sleep disturbance as assessed by SD-NRS [ Time Frame: baseline and 12 weeks ]
    Proportion of subjects reporting an improvement of at least 4 from baseline to Week 12 in sleep disturbance as assessed by (SD) NRS. The SD-NRS is an 11-point scale (0 -10) with higher scores indicating greater sleep disturbance.

  12. Change in Itch Intensity in patients with underlying atopy [ Time Frame: baseline and 12 weeks ]
    Change in itch intensity as assessed by PP-NRS in Prurigo Nodularis patients with underlying atopy. 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

  13. Change in Itch Intensity in patients without underlying atopy [ Time Frame: baseline and 12 weeks ]
    Change in itch intensity as assessed by PP-NRS in Prurigo Nodularis patients without underlying atopy. 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.

  14. Change in Itch Intensity in CPUO patients with High Eosinophilia [ Time Frame: baseline and 12 weeks ]
    Change in itch intensity as measured by PP-NRS in CPUO patients with high eosinophilia (greater than 500 eosinophils per micro-liter of blood). The PP-NRS is an 11-point single self-report item on a scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable.

  15. Cutaneous Biomarker Analysis - Gene Set Variation Analysis (GSVA). [ Time Frame: Baseline and 12 weeks ]
    Lesional and non-lesional skin biopsies will be compared for TH1/Th2/Th17/Th22 polarization before and after treatment.

  16. Systemic Biomarker Analysis - Gene Set Variation Analysis (GSVA). [ Time Frame: Baseline, 2 weeks and 12 weeks ]
    Plasma cytokines and peripheral blood mononuclear cells will be analyzed for TH1/Th2/Th17/Th22 polarization before and after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 worst itch 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05038982


Locations
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United States, Maryland
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Duke University
Pfizer
Investigators
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Principal Investigator: Shawn G Kwatra, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05038982    
Other Study ID Numbers: IRB00262268
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Prurigo
Neurodermatitis
Skin Manifestations
Dermatitis
Skin Diseases, Eczematous
Abrocitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action