Tapering of biologics in chronic rhinosinusitis with nasal polyps

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] - Otorhinolaryngologic Diseases [C09]

Trial duration

27 May 2025 → ongoing

Decision date (initial)

2025-04-28

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The objective is to evaluate the impact of prolonged dosing intervals of biologic therapy in patients with CRSwNP who have demonstrated stable, completely or partly controlled disease. Specifically, the study will assess at least continued degree of disease control after 52 weeks of prolonged dosing intervals in patients who have received treatment with Mepolizumab or Dupilumab for at least 18 months, with consistent completely or partly controlled disease for a minimum of 12 months.
The primary outcome is to find the percentage of patients achieving at least sustained degree of disease controll after tapering of biologics for CRSwNP. This will be evaluated by comparison of disease control assessments at weeks 0 and 52.

Secondary objectives 1

1. The secondary outcomes are 1: changes in health-related outcomes from baseline to 52 weeks, 2: to compare the two drugs in order to determine if one is better suited for prolonged dosing intervals. 3: lastly, identifying any factors associated with continued disease control.

Conditions and MedDRA coding

chronic rhinosinusitis with nasal polyps (CRSwNP)

Regulatory references

Plan to share IPD

Yes

IPD plan description

The patient will be offered presentation and explanation of the individualt data as well as overall study data and what this might mean to the patient. The data will be presented either by personal conversation or in letter form.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • ≥18 years of age. • Currently receiving treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) every four weeks. • Having received the biologic at unchanged dosing interval for at least three months. • For at least 1 year during treatment with biologics, the patients’ CRSwNP must be categorized as either "controlled" as defined by presence of none of the following 7 items, or as “partly controlled” as defined by presence of 1-2 of the following 7 items (see EPOS 2020 table in protocol): 1. Nasal blockage: present on most days of the week 2. Rhinorrhoea/postnasal drip: mucopurulent on most days of the week 3. Facial pain/pressure1: present on most days of the week 4. Sense of smell: impaired 5. Sleep disturbance or fatigue1: present 6. Nasal endoscopy: diseased mucosa 7. Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment.

Exclusion criteria 1

1. • Patients with no or limited response to biologics (“uncontrolled” in EPOS table in the protocol) • Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial • Patients who, because of language barriers, are not able to understand Danish written information and, thus, are not able to answer questionnaires • Patients who currently receive biologics for any other disease (asthma not included) • Patients who are not able to give informed consent (i.e., patients who are permanently incapable) • Patients who are not eligible because of the investigator’s judgement • Patients who experience pregnancy during the study will be excluded after an unscheduled visit – active IVF treatment (please see the protocol) • Unwillingness to follow the study procedure

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. In "controlled" patients presence of 0 & in "partly controlled" patients max. 2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment

Secondary endpoints 1

1. 1) changes in SNOT-22, ACQ and smell test scores from baseline to 52 weeks; 2) changes in disease control assessments from baseline to 52 weeks by given drug; and 3) baseline and demographic data such as: age, sex, comorbidities, BMI, level of education, duration of biologic treatment.

Investigational products

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

Test 2

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

Elizabeth Stevens Saporito

Public contact point

Organisation

Rigshospitalet

Contact name

Elizabeth Stevens Saporito

Third parties 1

Locations

1 EU/EEA country · 9 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 5 files

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

Application history

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