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: 20.0 Level: PT Classification code 10037083 Term: Prurigo System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Fasenra (Benralizumab)
Product Name: Benralizumab
Pharmaceutical Form: Solution for infusion in pre-filled syringe
Pharmaceutical form of the placebo: Injection
Route of administration of
Sponsors
Charité-Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of benralizumab for the treatment of pruritus in adult patients with chronic prurigo.;Secondary Objective: To assess the effect of benralizumab on activity, severity and control of disease, to assess the effect of benralizumab on patients’ itch-specific quality of life, and to assess the safety of benralizumab in patients with chronic prurigo.;Primary end point(s): The percent change from baseline in numerical rating scale of the worst itch (WI-NRS) to week 12 (weekly average maximum rating);Timepoint(s) of evaluation of this end point: Baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Effects on responder rates at week 4, 8 and 12 (defined by > 3 point WI-NRS improvement) • Absolute and Percent change from baseline in weekly average of the maximum pruritus and average pruritus WI-NRS at every week • Change in prurigo activity score (PAS) from baseline to week 4, 8 and 12 • Change in the overall disease control, as assessed by the prurigo control test (PCT) from baseline to week 4, 8 and 12 • Change in Investigator Global Assessment (IGA)-activity from baseline to week 4, 8 and 12 • Change in IGA-stage from baseline to week 4, 8 and 12 • Change in the patient’s quality of life (assessed by ItchyQoL, a pruritus-specific instrument to measure quality of life, and DLQI) • Sleep disturbance NRS • Safety and tolerability, including physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting;Timepoint(s) of evaluation of this end point: Baseline to week 4, 8 and 12 | — |
Countries
Germany
Contacts
Public ContactBenjamin Grimmer
Charité - Universitätsmedizin Berlin; Institute of Allergology
Outcome results
None listed