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

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...).

Study Overview

• Status: Recruiting
• Conditions: Patients With Chronic Pruritus for More Than 1 Month Who Have Received Immunotherapy
• Intervention / Treatment: Biological: characterisation of immunoglobulin subclasses

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vivien HEBERT, MD; Phone Number: 89 90 02 32 88; Email: vivien.hebert@chu-rouen.fr
• Study Contact Backup: Name: Armelle GUIDOTTI; Phone Number: 8265 023288; Email: armelle.guidotti@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • UHRouen
    • Contact: Vivien Hebert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with prurit	Biological: characterisation of immunoglobulin subclasses; For patients with positive anti BP180 and/or anti BP230 serology, a characterisation of the immunoglobulin subclasses will be performed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease	30 days
Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease	1 year
Patient survival	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Vivien HEBERT, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: 2020/0429/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No