Complete remission study

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

3 Apr 2025 → ongoing

Decision date (initial)

2025-02-09

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, Efficacy

The main objective is to find out if the patients that have been treated with a monoklonal antibody for nasal polyps, after years of treatmen, can stop the treatment with out recurrence of symptoms.

Secondary objectives 1

1. Is one of the two druge better than the orther to gain complete remission

Conditions and MedDRA coding

Chronic rrhinosinusitis with nasal polyps

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Inclusion criteria: At the time when the patient started biological treatment, they must have fulfilled the EPOS criteria for initiation of biologic treatment (REF EPOS): • Fulfil the criteria for CRSwNP • Presence of bilateral polyps in a patient • Had ESS (sinus surgery) (exceptional circumstances excluded) • Fulfil at least three of the following five criteria:  Evidence of type 2 inflammation  Need for (and treated with) systemic corticosteroids or contraindication to these  SNOT-22 score of 40 or above  Significant loss of smell  Asthma needing regular inhaled corticosteroids To enter this study, the patient must be • Above 18 years of age • Currently be in treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) with treatment every fourth week. This treatment should have been stable/unchanged for at least three months. • Within the latest year the patient must at all times have assessed the control of the CRS as controlled (from the following three categories: controlled, partly controlled, uncontrolled) REF EPOS • Within the latest year the patient must at all times have scored the symptoms of CRS five or below on a VAS scale from 0 – 10 (This includes nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell, sleep disturbance or fatigue) (REF EPOS) • Within the latest year the nasal endoscopy cannot have showed polyp score of more than 1+1 out of 4+4, further, now thick secretions or general oedema must have been present. • Within the latest year the patient is not allowed to have had ESS or rescue treatment for their CRSwNP (antibiotics or systemic steroids) • The patient must be able to understand Danish and able to sign an informed content.

Exclusion criteria 1

1. Exclusion criteria • In the twelve months of remission the patient is not allowed to have had AECRS (acute exacerbation of chronic rhinosinusitis). A common cold is allowed. • 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 (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 (LOCF) – active IVF treatment. (please look belove) • Malign disease within the last 5 years • Unwillingness to follow the study procedure

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. What percentage of patients can stop the biologic treatment and still be in complete remission

Secondary endpoints 1

1. Is there any differences in what drug the patients have been treated with

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

Kasper Aanæs

Public contact point

Organisation

Rigshospitalet

Contact name

Kasper Aanæs

Third parties 1

Sponsor responsibilities

Article 77 compliance

Rigshospitalet

Contact point sponsor

Rigshospitalet

Locations

1 EU/EEA country · 6 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 9 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