Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
Condition: Prurigo Nodularis; Pruritus; Chronic Pruritus; Chronic Prurigo; Skin Diseases
MeSH terms: Pruritus; Skin Diseases; Prurigo; Neurodermatitis
Intervention: Abrocitinib
Intervention description: 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 MeSH terms: Abrocitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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)

        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.