FESSnonFESS

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

2 May 2025 → ongoing

Decision date (initial)

2024-08-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514632-24-02

EudraCT number

2022-002923-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Therapy, Efficacy

Does surgical intervention in combination with biologic treatment give faster disease control

Conditions and MedDRA coding

Chronic Rhinosinusitis with Nasal Polyposis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients ≥ 18 years old at the time of signed informed consent (no upper limit)  Patients who are referred to the outpatient clinic for the following reasons: o Doctor’s diagnosis of CRS1  NPS ≥ 2+2 out of a score of 8 (max)  Severity measured as an SNOT22 score > 35  Type 2 inflammation (see below)  One FESS surgery in general anaesthesia performed prior to inclusion (no time limitations)  No course of systemic steroids within the last 3 months, whereas a daily low dose (5-10 mg) is allowed  Possible doctor’s diagnosis of asthma2

Exclusion criteria 1

1. Patients who, because of language barriers, are not able to understand written information and, thus, are not able to answer questionnaires  Patients who currently receive biologics for any other disease  Patients who have previously or currently received biologics for CRS or asthma  Patients who are not able to give informed consent (i.e., patients who are permanently incapable)  Patients who meet ≥1 of the following:Malignant lung disease o Cardiac disease of clinical importance o Current pregnancy and breastfeeding, as well as planning to be pregnant in the near future o Unwillingness to have FESS performed  Patients needing FESS or systemic steroids (OCS) during the study period will be excluded after an unscheduled visit (last observation carried forward (LOCF))  Patients who are not eligible because of the investigator’s judgement  Reaction towards Mepolizumab and one or more of the adjuvants.  Pregnancy during the study will be excluded after an unscheduled visit (LOCF)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in SNOT-22 score, Nasal polyp score and smell

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Anne-Sophie Homøe

Public contact point

Organisation

Rigshospitalet

Contact name

Anne-Sophie Homøe

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications