search
Back to results

Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy (BPA_immun)

Primary Purpose

Patients With Chronic Pruritus for More Than 1 Month Who Have Received Immunotherapy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
characterisation of immunoglobulin subclasses
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patients With Chronic Pruritus for More Than 1 Month Who Have Received Immunotherapy

Eligibility Criteria

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

Inclusion Criteria: Patient currently receiving immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination OR patient who has received immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination within the last 6 months. Patients with chronic (> 1 month) diffuse pruritus, which started after the start of immunotherapy and in the absence of an obvious pruritic dermatosis. Woman of childbearing age with effective contraception (see GTFG) (estrogen-progestin or intrauterine device or tubal ligation) for 1 month (negative urine/blood pregnancy test) or Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) Major patient Patient having read and understood the information letter and signed the consent form Patient affiliated to a social security scheme Exclusion Criteria: Pruritus prior to immunotherapy. Bullous pemphigoid prior to immunotherapy End-stage chronic renal failure (GFR < 15ml/min or dialysis) Clinical jaundice or total bilirubin > 34 µmol/L Hepatic cholestasis Diabetes mellitus complicated by diabetic neuropathy. History of polycythemia vera History of Hodgkin's lymphoma iron deficiency anemia Current treatment including DPP-4 inhibitors (vildagliptin, linagliptin) Treatment with systemic corticosteroids or immunosuppressant for more than one month. Pregnant or parturient or breastfeeding woman or absence of proven contraception · Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship

Sites / Locations

  • UHRouenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with prurit

Arm Description

Outcomes

Primary Outcome Measures

Number of patients on immunotherapy with chronic diffuse pruritus for at least 1 month with positive anti BP180 and/or anti BP230 serology

Secondary Outcome Measures

Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease
Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease
Patient survival

Full Information

First Posted
January 9, 2023
Last Updated
May 23, 2023
Sponsor
University Hospital, Rouen
search

1. Study Identification

Unique Protocol Identification Number
NCT05689463
Brief Title
Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy
Acronym
BPA_immun
Official Title
Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
February 23, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the prevalence of positive anti BP180 and/or anti BP230 serology in the serum of patients with chronic and diffuse pruritus for at least 1 month under immunotherapy and in the absence of obvious pruritic dermatosis (e.g. scabies, contact eczema...).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Chronic Pruritus for More Than 1 Month Who Have Received Immunotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with prurit
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
characterisation of immunoglobulin subclasses
Intervention Description
For patients with positive anti BP180 and/or anti BP230 serology, a characterisation of the immunoglobulin subclasses will be performed
Primary Outcome Measure Information:
Title
Number of patients on immunotherapy with chronic diffuse pruritus for at least 1 month with positive anti BP180 and/or anti BP230 serology
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease
Time Frame
30 days
Title
Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease
Time Frame
1 year
Title
Patient survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient currently receiving immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination OR patient who has received immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination within the last 6 months. Patients with chronic (> 1 month) diffuse pruritus, which started after the start of immunotherapy and in the absence of an obvious pruritic dermatosis. Woman of childbearing age with effective contraception (see GTFG) (estrogen-progestin or intrauterine device or tubal ligation) for 1 month (negative urine/blood pregnancy test) or Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit) Major patient Patient having read and understood the information letter and signed the consent form Patient affiliated to a social security scheme Exclusion Criteria: Pruritus prior to immunotherapy. Bullous pemphigoid prior to immunotherapy End-stage chronic renal failure (GFR < 15ml/min or dialysis) Clinical jaundice or total bilirubin > 34 µmol/L Hepatic cholestasis Diabetes mellitus complicated by diabetic neuropathy. History of polycythemia vera History of Hodgkin's lymphoma iron deficiency anemia Current treatment including DPP-4 inhibitors (vildagliptin, linagliptin) Treatment with systemic corticosteroids or immunosuppressant for more than one month. Pregnant or parturient or breastfeeding woman or absence of proven contraception · Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivien HEBERT, MD
Phone
02 32 88
Ext
89 90
Email
vivien.hebert@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Armelle GUIDOTTI
Phone
023288
Ext
8265
Email
armelle.guidotti@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivien HEBERT, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHRouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivien Hebert, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy

We'll reach out to this number within 24 hrs