BridgeMD
New treatment option for Nasal Polyps
Official title Complete Remission After Treatment With Biologics for Nasal Polyps
ClinicalTrials.gov ID: NCT07268313
What this study is testing
What is DUPIXENT®?
DUPIXENT® is an investigational medicine, being studied as a potential treatment for nasal polyps.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this RCT the investigators randomize patients who are treated with biologic treatment (Nucala or Dupixent) due to nasal polyps and have controlled disease within the last year to either stop treatment og continue as a control group.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 5.1 (all must be fulfilled) At the time when the patient started biological treatment, they must have fulfilled the EPOS criteria for initiation of...
- 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...
You likely can't join if
- In the twelve months of remission the patient is not allowed to have had AECRS (acute exacerbation of chronic rhinosinusitis). A common cold is...
- Polyp removal in the out-patient clinic may not have been performed within the last 3 months.
- In the twelve months of remission the patient cannot at any time have scored higher than 1.2 on the ACQ questionnaire, meaning that the patient does...
- 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)
See the full eligibility criteria
- 5.1 (all must be fulfilled) 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...
- 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 scored all the below symptoms of CRS five or below on a VAS scale from 0 - 10 - Doing this, it is according to the EPOS defined as controlled disease. The items...
- Within the latest year the nasal endoscopy cannot have showed polyp score of more than 1+1 out of 4+4, further, no 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.
- 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.
- Polyp removal in the out-patient clinic may not have been performed within the last 3 months.
- In the twelve months of remission the patient cannot at any time have scored higher than 1.2 on the ACQ questionnaire, meaning that the patient does not have uncontrolled asthma (Appendix 3).
- 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)
- Patients who have or recently have had illness, such as cancer that or its treatment is expected to significantly affect morbidity and/or quality of life in the next two years
- Unwillingness to follow the study procedure
- Hypersensitivity to any of either Dupilumab or Mepolizumab.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Region H, Denmark
- Hillerød, Region H, Denmark
- Køge, Region Sj, Denmark
- Odense, Region Syd, Denmark
- Vejle, Region S, Denmark
- Gødstrup, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Region H, Denmark; Hillerød, Region H, Denmark; Køge, Region Sj, Denmark; Odense, Region Syd, Denmark; Vejle, Region S, Denmark; Gødstrup, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.