BP180 and BP230 antibody testing for people with new chronic itching after immunotherapy
Official title: Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy
Run by University Hospital, Rouen · NCT05689463 · Data updated 2026-11-12
This study will test whether people receiving PD-1/PD-L1 immunotherapy who develop widespread itching have BP180 or BP230 antibodies in their blood.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Rouen Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, atezolizumab, durvalumab, immunotherapy |
| Locations | 1 site (Rouen) |
| Status | Recruiting |
| Started | February 23, 2023 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT05689463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who developed new, diffuse itching for more than one month after starting pembrolizumab, nivolumab, atezolizumab, or durvalumab, who are currently receiving those drugs or received them within the last six months, and who have no obvious other cause of pruritus.
✕Probably not a fit
People whose itching began before immunotherapy, who have a clear alternative pruritic diagnosis (for example scabies or contact eczema), or who already have bullous pemphigoid are unlikely to benefit from this testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial collects blood from adults who developed diffuse pruritus lasting more than one month after starting PD-1/PD-L1 immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) to measure anti-BP180 and anti-BP230 antibodies and to characterize immunoglobulin subclasses. Eligible participants may be currently on immunotherapy or have stopped within the past six months, provided they do not have an obvious pruritic dermatosis and did not have pruritus before treatment. The primary approach is serologic testing to determine the prevalence of these autoantibodies in this specific post-immunotherapy itch population. The study is performed at the University Hospital Rouen and involves blood draws and laboratory analysis.
Why it matters
Potential benefit: If antibodies are found, this could identify an autoimmune cause of itching and help guide more specific treatments to reduce symptoms.
How similar studies have gone: Case reports and small series have linked checkpoint inhibitors to BP-like autoantibodies and frank bullous pemphigoid, but the prevalence of BP180/BP230 antibodies in patients with diffuse pruritus without blisters remains poorly defined.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UHRouen
Rouen, France Recruiting
Study contacts
- Principal investigator: Vivien HEBERT, MD — University Hospital, Rouen
- Study coordinator: Vivien HEBERT, MD
- Email: vivien.hebert@chu-rouen.fr
- Phone: 02 32 88
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.