Benralizumab tested in patients with chronic prurigo.

Phase 1

• Conditions: Chronic prurigo in adult patients.Chronic Prurigo is characterized by the presence of chronic pruritus, multiple localized or generalized, pruriginous lesions, and the history and/or signs of a prolonged scratching behavior.; MedDRA version: 20.0Level: PTClassification code 10037083Term: PrurigoSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-002818-13-DE
• Lead Sponsor: Charité-Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-27
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Diagnosis: chronic prurigo (defined as ongoing disease)
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

1.Chronic pruritus resulting from another active condition other than CPG
2.Unilateral lesions of prurigo (e.g., 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 §40a subsection 2 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified