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Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT05689463•University Hospital, Rouen

View on ClinicalTrials.gov

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...).

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

UHRouen

Rouen, France

Key Dates

Start Date

February 23, 2023

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

February 6, 2026

Enrollment

100

ESTIMATED participants

Conditions

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

Interventions

characterisation of immunoglobulin subclasses

BIOLOGICAL

Contacts

Vivien HEBERT, MD

CONTACT

02 32 88 vivien.hebert@chu-rouen.fr

Armelle GUIDOTTI

CONTACT

023288 armelle.guidotti@chu-rouen.fr