NCT07187583 Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
| NCT ID | NCT07187583 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Chronic Rhinosinusitis With Nasal Polyps |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-06-05 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 135 participants in total. It began in 2025-06-05 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal polyps (CRSwNP).
Eligibility Criteria
Inclusion Criteria: * ≥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 one year during treatment with biologics, the patients' CRSwNP must be categorized as "partly controlled" as defined by presence of 1-2 of the following seven items (also available in 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/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 of which 1-5 will be scored by the patient using VAS (0-10) and noted above 5. Exclusion Criteria: * Patients with excellent response to biologics (0 of the above-mentioned 7 items for partly controlled disease) * Patients with no or limited response to biologics (\>2 of the above-mentioned 7 items for partly controlled disease) * 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 below) * Unwillingness to follow the study procedure
Contact & Investigator
Christian von Buchwald, MD, DMSc, prof.
STUDY DIRECTOR
Rigshospitalet, Dept. of Otorhinolaryngology, Head and Neck Surgery & Audiology
Frequently Asked Questions
Who can join the NCT07187583 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinosinusitis With Nasal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07187583 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07187583 currently recruiting?
Yes, NCT07187583 is actively recruiting participants. Contact the research team at este0027@regionh.dk for enrollment information.
Where is the NCT07187583 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Esbjerg, Denmark and 5 additional locations.
Who is sponsoring the NCT07187583 clinical trial?
NCT07187583 is sponsored by Rigshospitalet, Denmark. The principal investigator is Christian von Buchwald, MD, DMSc, prof. at Rigshospitalet, Dept. of Otorhinolaryngology, Head and Neck Surgery & Audiology. The trial plans to enroll 135 participants.