This is a randomized, double-blind, placebo-controlled, Phase 2, 12-Week treatment study with a 10-Week Follow-up period to assess the efficacy and safety of Benralizumab (anti-IL5Rα) in adult patients with chronic prurigo (BICPIC)
Chronic Prurigo (CPG) is a skin disease of unknown incidence and prevalence that can occur in all age groups including children, but which is most prevalent in elderly people. CPG was defined as a distinct disease in 2018 by the Task Force Pruritus of the EADV and diagnosis is based on the presence of chronic pruritus, multiple localized or generalized, pruriginous lesions, and the history and/or signs of a prolonged scratching behavior. While CPG is a disease in its own right, the initial causes of chronic pruritus can be manifold and may be of dermatological, systemic, neurological, psychiatric/psychosomatic, multifactorial or of unknown origin. The pruriginous lesions can be skin-colored, pink or red, hyperkeratotic or excoriated, scaling and/or crusted papules and/or nodules and/or plaques. Depending on the predominant clinical phenotype, CPG subtypes have been defined as papular type, nodular type (also called prurigo nodularis), plaque type, umbilicated type or linear prurigo. Of these, the nodular type is the most frequent one. Although CPG patients are sometimes covered in excoriated intensely pruritic nodules, these skin lesions are always secondary to an intense itch-scratch cycle. Thus, an effective treatment of itch will also lead to the disappearance of the skin lesions. The vast majority of CPG patients are resistant to common therapy and desperate for novel treatment options. Consequently, those affected by intensely itchy CPG are dramatically impaired in their quality of life. Currently, there are no approved therapies for the treatment of CPG available. The study aims to assess the exploratory efficacy and safety of benralizumab, a monoclonal antibody against IL5Rα in adult patients with chronic prurigo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Fasenra 60mg s.c. administration at weeks 0,4 and 8
Placebo s.c. administration at weeks 0,4 and 8
Hautklinik Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie
Kiel, Schleswig-Holstein, Germany
Charite University Medicine
Berlin, Germany
Numerical rating scale of the worst itch (WI-NRS)
Percent change from baseline in numerical rating scale of the worst itch
Time frame: Week 0 to week 12
Effects on responder rates
Effects on responder rates at week 4, 8 and 12 (defined by \> 3 point change on WI-NRS)
Time frame: 12 weeks
Pruritus WI-NRS
Absolute and Percent change from baseline in weekly average of the maximum pruritus and average pruritus WI-NRS at every week
Time frame: 12 weeks
Prurigo Activity Score (PAS)
Change in prurigo activity score (PAS) from baseline to week 4, 8 and 12
Time frame: 12 weeks
Prurigo Control Test (PCT)
Change in the overall disease control, as assessed by the prurigo control test (PCT) from baseline to week 4, 8 and 12
Time frame: 12 weeks
Investigator Global Assessment (IGA)
Change in Investigator Global Assessment (IGA)-activity from baseline to week 4, 8 and 12
Time frame: 12 weeks
Investigator Global Assessment (IGA)-stage
Change in IGA-stage from baseline to week 4, 8 and 12
Time frame: 12 weeks
Change in the patient's quality of life
patient's quality of life assessed by ItchyQoL and Dermatology Life Quality index (DLQI)
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Time frame: 12 weeks
Numerical rating scale (NRS) of sleep disturbance
Effects on sleep disturbance NRS
Time frame: 12 weeks