Benralizumab in Chronic Prurigo - Investigating Clinical Efficacy (BICPIC)

Study Overview
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Brief Summary
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This is a randomized, double-blind, dlacebo-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)

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Prurigo

Intervention / Treatment
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* Drug: Fasenra Prefilled Syringe
* Other: Matching Placebo Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is informed about study procedures and medications and has given written informed consent before any assessment. Patient is able to communicate with the investigator, understands and complies with the requirements of the study. Clinical diagnosis of CPG for at least 6 months with: Severe pruritus with WI-NRS rating ≥ 6 (Mean of the worst daily intensity over the previous 3 days at Screening and over the previous week at baseline [minimum of at least 5 days during the week preceding the baseline visit]). Pruriginous nodular, papular, plaque and/or umbilicated lesions on upper limbs, trunk, and/or lower limbs At least 20 CPG lesions on the entire body with a bilateral distribution Willing and able to complete a daily symptom Diary for the duration of the study and adhere to the study visit schedules. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control Negative corona test, twice vaccinated or recovered from Covid within the last 6 months Exclusion Criteria: Chronic pruritus resulting from another active condition other than CPG Unilateral lesions of prurigo (eg, only one arm affected) Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. Patients who previously received benralizumab History of anaphylaxis to any biologic therapy or vaccine. Any disorder that is not stable in the opinion of the Investigator and could: (a) Affect the safety of the participant throughout the study, (b) Influence the findings of the studies or their interpretations, (c) Impede the participant's ability to complete the entire duration of study. Inability to comply with study and follow-up procedures. Current malignancy, or history of malignancy within the last 5 years Subjects who live in detention on court order or on regulatory action as per local and national law (see §40 subsection 1 sentence 3 no. 4 Arzneimittelgesetz) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test Patients with active COVID-19 infection. Patients with symptoms consistent with COVID-19 infection should be tested prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:1 (Benralizumab : Placebo)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benralizumab<br>Fasenra 60mg s.c. administration | Drug: Fasenra Prefilled Syringe<br>* Fasenra 60mg s.c. administration at weeks 0,4 and 8<br>* Other names: Benralizumab;|
| Placebo Comparator: Placebo<br>Placebo s.c. administration | Other: Matching Placebo Solution<br>* Placebo s.c. administration at weeks 0,4 and 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale of the worst itch (WI-NRS) | Percent change from baseline in numerical rating scale of the worst itch | Week 0 to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on responder rates | Effects on responder rates at week 4, 8 and 12 (defined by > 3 point change on WI-NRS) | 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 | 12 weeks | 
| Prurigo Activity Score (PAS) | Change in prurigo activity score (PAS) from baseline to week 4, 8 and 12 | 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 | 12 weeks | 
| Investigator Global Assessment (IGA) | Change in Investigator Global Assessment (IGA)-activity from baseline to week 4, 8 and 12 | 12 weeks | 
| Investigator Global Assessment (IGA)-stage | Change in IGA-stage from baseline to week 4, 8 and 12 | 12 weeks | 
| Change in the patient's quality of life | patient's quality of life assessed by ItchyQoL and Dermatology Life Quality index (DLQI) | 12 weeks | 
| Numerical rating scale (NRS) of sleep disturbance | Effects on sleep disturbance NRS | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benralizumab in Chronic Prurigo