Benralizumab in Chronic Prurigo - Investigating Clinical Efficacy (BICPIC)

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

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)

Study Overview

• Status: Withdrawn
• Conditions: Chronic Prurigo
• Intervention / Treatment: Drug: Fasenra Prefilled Syringe; Other: Matching Placebo Solution

Detailed Description

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
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Charite University Medicine
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Hautklinik Universitätsklinikum Münster
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient is informed about study procedures and medications and has given written informed consent before any assessment.
2. Patient is able to communicate with the investigator, understands and complies with the requirements of the study.

3. 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
4. Willing and able to complete a daily symptom Diary for the duration of the study and adhere to the study visit schedules.
5. Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control
6. Negative COVID-19 test

Exclusion Criteria:

1. Chronic pruritus resulting from another active condition other than CPG
2. Unilateral lesions of prurigo (eg, only one arm affected)
3. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
4. Patients who previously received benralizumab
5. Patients with hypersensitivity to any of the excipients of the IMP or history of anaphylaxis to any biologic therapy or vaccine.
6. 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.
7. Inability to comply with study and follow-up procedures.
8. Current malignancy, or history of malignancy within the last 5 years
9. Current active liver disease
10. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
11. 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)
12. 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
13. Patients with active COVID-19 infection. Patients with symptoms consistent with COVID-19 infection should be tested prior to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Martin Metz, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Benralizumab in Chronic Prurigo
• Additional Relevant MeSH Terms: Skin Diseases; Prurigo; Anti-Asthmatic Agents; Respiratory System Agents; Benralizumab
• Other Study ID Numbers: DEALSZ-2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No