Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05689463

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

Led by University Hospital, Rouen · Updated on 2026-02-06

100

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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...).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (estrogen-progestin or intrauterine device or tubal ligation) for 1 month (negative urine/blood pregnancy test) or postmenopausal woman with confirmed diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
  • Adult patient.
  • Patient having read and understood the information letter and signed the consent form.
  • Patient affiliated to a social security scheme
Not Eligible

You will not qualify if you...

  • 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 �b5mol/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 immunosuppressants 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UHRouen

Rouen, France

Actively Recruiting

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Research Team

V

Vivien HEBERT, MD

CONTACT

A

Armelle GUIDOTTI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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