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Benralizumab in Chronic Prurigo - Investigating Clinical Efficacy (BICPIC)

Primary Purpose

Chronic Prurigo

Status

Not yet recruiting

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Fasenra Prefilled Syringe

Matching Placebo Solution

About this trial

This is an interventional treatment trial for Chronic Prurigo focused on measuring Benralizumab in Chronic Prurigo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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
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.

Sites / Locations

Hautklinik Universitätsklinikum Münster
Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie
Charite University Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Benralizumab

Placebo

Arm Description

Fasenra 60mg s.c. administration

Placebo s.c. administration

Outcomes

Primary Outcome Measures

Numerical rating scale of the worst itch (WI-NRS)

Percent change from baseline in numerical rating scale of the worst itch

Secondary Outcome Measures

Effects on responder rates

Effects on responder rates at week 4, 8 and 12 (defined by > 3 point change on WI-NRS)

Pruritus WI-NRS

Absolute and Percent change from baseline in weekly average of the maximum pruritus and average pruritus WI-NRS at every week

Prurigo Activity Score (PAS)

Change in prurigo activity score (PAS) from baseline to week 4, 8 and 12

Prurigo Control Test (PCT)

Change in the overall disease control, as assessed by the prurigo control test (PCT) from baseline to week 4, 8 and 12

Investigator Global Assessment (IGA)

Change in Investigator Global Assessment (IGA)-activity from baseline to week 4, 8 and 12

Investigator Global Assessment (IGA)-stage

Change in IGA-stage from baseline to week 4, 8 and 12

Change in the patient's quality of life

patient's quality of life assessed by ItchyQoL and Dermatology Life Quality index (DLQI)

Numerical rating scale (NRS) of sleep disturbance

Effects on sleep disturbance NRS

Full Information

NCT ID

NCT05528913

First Posted

September 1, 2022

Last Updated

February 6, 2023

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT05528913

Brief Title

Benralizumab in Chronic Prurigo - Investigating Clinical Efficacy (BICPIC)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2023 (Anticipated)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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)

Detailed Description

Chronic Prurigo (CPG) is a skin disease of unknown incidence and prevalence that can occur in all age groups including children, but which is most prevalent in elderly people. CPG was defined as a distinct disease in 2018 by the Task Force Pruritus of the EADV and diagnosis is based on the presence of chronic pruritus, multiple localized or generalized, pruriginous lesions, and the history and/or signs of a prolonged scratching behavior. While CPG is a disease in its own right, the initial causes of chronic pruritus can be manifold and may be of dermatological, systemic, neurological, psychiatric/psychosomatic, multifactorial or of unknown origin. The pruriginous lesions can be skin-colored, pink or red, hyperkeratotic or excoriated, scaling and/or crusted papules and/or nodules and/or plaques. Depending on the predominant clinical phenotype, CPG subtypes have been defined as papular type, nodular type (also called prurigo nodularis), plaque type, umbilicated type or linear prurigo. Of these, the nodular type is the most frequent one. Although CPG patients are sometimes covered in excoriated intensely pruritic nodules, these skin lesions are always secondary to an intense itch-scratch cycle. Thus, an effective treatment of itch will also lead to the disappearance of the skin lesions. The vast majority of CPG patients are resistant to common therapy and desperate for novel treatment options. Consequently, those affected by intensely itchy CPG are dramatically impaired in their quality of life. Currently, there are no approved therapies for the treatment of CPG available. The study aims to assess the exploratory efficacy and safety of benralizumab, a monoclonal antibody against IL5Rα in adult patients with chronic prurigo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Prurigo

Keywords

Benralizumab in Chronic Prurigo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

2:1 (Benralizumab : Placebo)

Masking

ParticipantInvestigator

Masking Description

double-blind

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Benralizumab

Arm Type

Experimental

Arm Description

Fasenra 60mg s.c. administration

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo s.c. administration

Intervention Type

Drug

Intervention Name(s)

Fasenra Prefilled Syringe

Other Intervention Name(s)

Benralizumab

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Matching Placebo Solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Numerical rating scale of the worst itch (WI-NRS)

Description

Percent change from baseline in numerical rating scale of the worst itch

Time Frame

Week 0 to week 12

Secondary Outcome Measure Information:

Title

Effects on responder rates

Description

Effects on responder rates at week 4, 8 and 12 (defined by > 3 point change on WI-NRS)

Time Frame

12 weeks

Title

Pruritus WI-NRS

Description

Absolute and Percent change from baseline in weekly average of the maximum pruritus and average pruritus WI-NRS at every week

Time Frame

12 weeks

Title

Prurigo Activity Score (PAS)

Description

Change in prurigo activity score (PAS) from baseline to week 4, 8 and 12

Time Frame

12 weeks

Title

Prurigo Control Test (PCT)

Description

Change in the overall disease control, as assessed by the prurigo control test (PCT) from baseline to week 4, 8 and 12

Time Frame

12 weeks

Title

Investigator Global Assessment (IGA)

Description

Change in Investigator Global Assessment (IGA)-activity from baseline to week 4, 8 and 12

Time Frame

12 weeks

Title

Investigator Global Assessment (IGA)-stage

Description

Change in IGA-stage from baseline to week 4, 8 and 12

Time Frame

12 weeks

Title

Change in the patient's quality of life

Description

patient's quality of life assessed by ItchyQoL and Dermatology Life Quality index (DLQI)

Time Frame

12 weeks

Title

Numerical rating scale (NRS) of sleep disturbance

Description

Effects on sleep disturbance NRS

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 corona test, twice vaccinated or recovered from Covid within the last 6 months Exclusion Criteria: 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 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martin Metz, Prof.

Phone

+4930450518159

martin.metz@charite.de

First Name & Middle Initial & Last Name or Official Title & Degree

Hanna Bonnekoh, MD

Phone

+4930450618077

hanna.bonnekoh@charite.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Metz, Prof.

Organizational Affiliation

Charité University, Berlin, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hautklinik Universitätsklinikum Münster

City

Münster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48149

Country

Germany

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonja Staender, Prof.

sonja.staender@ukmuenster.de

First Name & Middle Initial & Last Name & Degree

Nina Magnolo, MD

nina.magnolo@ukmuenster.de

Facility Name

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

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arndt Guido Heine, Prof.

gheine@dermatology.uni-kiel.de

First Name & Middle Initial & Last Name & Degree

Sascha Gerdes, MD

sgerdes@dermatology.uni-kiel.de

Facility Name

Charite University Medicine

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin Metz, Prof.

martin.metz@charite.de

First Name & Middle Initial & Last Name & Degree

Hanna Bonnekoh, MD

hanna.bonnekoh@charite.de

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Benralizumab in Chronic Prurigo - Investigating Clinical Efficacy (BICPIC)

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