Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Prurit… (NCT05038982) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
United States20 participantsStarted 2021-09-09
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
*…
What they're measuring
1
Percent Change in Weekly Average Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline to Week 12