Development of an assay for endotyping nasal polyps via Interleukin-5 signaling and predicting a response to mepolizumab therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034017

Enrollment

Registered

2024-04-11

Start date

2024-05-17

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J33

Interventions

Group 1: Phase 1: Ex-vivo analysis of intraoperatively obtained nasal polyp tissue from patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) undergoing sinus surgery. Phase 2/3: Longitudin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Recurrence of bilateral nasal polyps after one or more sinus surgeries despite current therapy with local and/or systemic cortisone therapy - Nasal polyp score = 4 out of 8 - SNOT-22 (sino-nasal outcome test-22) = 35 points - total symptom VAS (visual analog scale) = 5 out of 10 cm or 10 out of 20 cm - Evidence of type 2 inflammation [13]: Tissue eosinophils = 10/hpf17 or blood eosinophils = 250u/l or total IgE = 100IU/ml

Exclusion criteria

Exclusion criteria: - Infectious diseases such as HIV, hepatitis B and C - Tumor diseases - Autoimmune or non-type 2 inflammatory diseases - Alcohol consumption in the last 4 weeks and positive rapid test kit result of ethyl glucuronide in urine - Cigarette consumption in the last 4 weeks and positive rapid test kit result of cotinine in urine - Use of illegal drugs in the last 12 weeks and positive rapid test kit result - Therapy with other biologics in the last 12 weeks - Acute infection or elevation of both leukocytes and C-reactive protein in the blood - Use of systemic steroids in the last 4 weeks18 - pregnancy and breast-feeding

Design outcomes

Primary

Measure	Time frame
Characterization and differentiation of chronic rhinosinusitis with nasal polyps (CRSwNP) through the interleukin-5 signaling pathway and prediction of response to therapy with mepolizumab (from nasal tissue, nasal secretions, whole blood, serum).	—

Secondary

Measure	Time frame
identification of IL-5/mepolizumab target cells	—

Countries

Germany

Contacts

Public ContactJonas J.-H. Park

Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie, St. Josefs-Hospital Hagen der Kath. Krankenhaus Hagen GmbH

jonas.park@uni-wh.de+492331805549

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026