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NCT Number: NCT05689463

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

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...).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHRouen

Rouen, France

Location status: Recruiting

Location contact

Vivien Hebert, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

characterisation of immunoglobulin subclasses

Biological

For patients with positive anti BP180 and/or anti BP230 serology, a characterisation of the immunoglobulin subclasses will be performed

Primary outcomes

  1. 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 outcomes

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

    Time frame: 30 days

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

    Time frame: 1 year

  3. Patient survival

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Armelle GUIDOTTI

CONTACT

[email protected]

023288 ext. 8265

Vivien HEBERT, MD

CONTACT

[email protected]

02 32 88 ext. 89 90

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: BPA_immun

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 19, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.