Benralizumab in Chronic Prurigo - Investigating Clinical Efficacy (BICPIC)

NCT05528913 | Withdrawn Phase 2

• 1 other identifier: DEALSZ-2021-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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)

Conditions

Chronic Prurigo

Keywords

Benralizumab in Chronic Prurigo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Effects on responder rates

  12 weeks

• Pruritus WI-NRS

  12 weeks

• Prurigo Activity Score (PAS)

  12 weeks

• Prurigo Control Test (PCT)

  12 weeks

• Investigator Global Assessment (IGA)

  12 weeks

Study Arms (2)

Benralizumab

EXPERIMENTAL

Fasenra 60mg s.c. administration

Drug: Fasenra Prefilled Syringe

Placebo

PLACEBO COMPARATOR

Placebo s.c. administration

Other: Matching Placebo Solution

Interventions

Fasenra Prefilled Syringe DRUG

Fasenra 60mg s.c. administration at weeks 0,4 and 8

Also known as: Benralizumab

Benralizumab

Matching Placebo Solution OTHER

Placebo s.c. administration at weeks 0,4 and 8

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 COVID-19 test

You may not qualify if:

• 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
• Patients with hypersensitivity to any of the excipients of the IMP or 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
• Current active liver disease
• A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (3)

Hautklinik Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charite University Medicine

Berlin, 12203, Germany

Location

MeSH Terms

Interventions

benralizumab

Study Officials

• Martin Metz, Prof.

  Charité University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 2:1 (Benralizumab : Placebo)

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: October 1, 2023
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)