Benralizumab in Chronic Prurigo - Investigating Clinical Efficacy (BICPIC)

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, dlacebo-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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Benralizumab

Criteria

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 corona test, twice vaccinated or recovered from Covid within the last 6 months

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. 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. 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)

10. 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

11. Patients with active COVID-19 infection. Patients with symptoms consistent with COVID-19 infection should be tested prior to enrollment.