| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | 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. | Chronische Prurigo bei erwachsenen Patienten.
Chronische Prurigo ist gekennzeichnet durch chronischen Pruritus, multiplen lokalisierten oder generalisierten pruriginösen Läsionen und der Vorgeschichte und / oder Anzeichen eines anhaltenden Kratzverhaltens.
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| E.1.1.1 | Medical condition in easily understood language | | Chronic prurigo is a disease with chronic itch, signs of repeated scratching on the skin and presence of itchy skin lesions | | Chronische Prurigo ist eine Krankheit mit chronischem Juckreiz, Anzeichen von wiederholtem Kratzen auf der Haut und dem Auftreten von juckenden Hautläsionen | |
| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 | | E.1.2 | Level | PT | | E.1.2 | Classification code | 10037083 | | E.1.2 | Term | Prurigo | | E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders | |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | | To assess the efficacy of benralizumab for the treatment of pruritus in adult patients with chronic prurigo. | |
| E.2.2 | Secondary objectives of the trial | | 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. | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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
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| E.4 | Principal 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.
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| E.5 End points |
| E.5.1 | 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) | |
| E.5.1.1 | Timepoint(s) of evaluation of this end point | |
| E.5.2 | 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 | |
| E.5.2.1 | Timepoint(s) of evaluation of this end point | | Baseline to week 4, 8 and 12 | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 | The trial involves single site in the Member State concerned | No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | | The end of trial is defined as last patient, last visit. | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 3 |
| E.8.9.1 | In the Member State concerned months | 2 |
| E.8.9.1 | In the Member State concerned days | |
