Trials Sponsors Conditions Drugs Pricing

Conditions

chronic rhinosinusitis with nasal polyps

Outcome Measures

Primary Outcomes (3)

Change in tight junction expression (Occludin, ZO -1, -2, -3 claudin-1, -4, -7) between baseline, 12 weeks and 24 weeks of add-on treatment evaluated with RTq-PCR and with immunohistochemistry (IHC)
Look at the change in mucosal explant integrity between baseline, 12 weeks, and 24 weeks of add on treatment with Dupilumab by means of Ussing Chambers.
Change in gene expression profiling between baseline, 12 weeks and 24 weeks of add on treatment with Dupilumab by bulk RNA sequencing.

Secondary Outcomes (7)

Change in inflammatory markers in blood: IgE, blood eosinophils, ECP, IL-4, IL-5, IL-13 between baseline 12 weeks and 24 weeks of add on treatment with Dupilumab
Change in markers of remodelling in serum: MMP-9, MMP-12, CC-16 between baseline, 12 weeks, and 24 weeks of add on treatment with Dupilumab.
Evolution of the following patient reported outcomes (PROs) between baseline and 24 weeks of add on treatment with Dupilumab and the follow up visit. o Visual analogue scale (VAS) o Sino-nasal outcome test-22 (SNOT-22) o University of Pennsylvania smell identification test (UPSIT) o Asthma quality of life questionnaire (AQLQ) o Asthma control questionnaires 6-item version (ACQ-6) o Patients’ global impression of change (PGI-Change)
Change in FeNo levels between baseline, 12 weeks, and 24 weeks of add on treatment with Dupilumab.
Change in IOS measurements between baseline, 12 weeks, and 24 weeks of add on treatment with Dupilumab
+2 more secondary outcomes

Interventions

Placebo matching to dupilumabType not reported

Dupixent 300 mg solution for injection in pre-filled syringeType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Dupixent 300 mg solution for injection in pre-filled syringe
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Dupixent 300 mg solution for injection in pre-filled syringe
Named ingredient: dupilumab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
Woman of child bearing potential (WOCBP) (i.e. fertile women, following menarche and until becoming post-menopausal unless permanently sterile) and fertile man (man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy) should use highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. WOCBP and fertile men should practice adequate contraception during the study until 3 months post-study. Postmenopausal women (defined as at least 12 consecutive months with no menses without an alternative medical cause) are not required to use additional contraception.

Sponsors & Collaborators

UZ Leuven
Type not reportedlead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Peter Hellings016336368 peter.hellings@uzleuven.be

Central Study Contacts

Elien Borgers

016342037 elien.borgers@uzleuven.be

Study Design

Study Type: interventional
Phase: phase 4

Study Record Dates

First Submitted

April 17, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-504014-30-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 03:33:43 UTC

Documents

Summary for lay persons_final

You may not qualify if:

Participant has a history of anaphylaxis to components of the study medication
Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint such as: a. Antrochoanal polyps b. Nasal septal deviation that would occlude at least one nostril c. Acute sinusitis, nasal infection, or upper respiratory infection at V1 or in the 2 weeks before V1 d. Ongoing rhinitis medicamentosa e. Churg-Strauss syndrome, Young’s syndrome, Kartagener’s syndrome or dyskinetic ciliary syndromes, Cystic fibrosis f.Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
Patients with a change in vision or with a history of increased ocular pressure, glaucoma and/or cataracts.
Patients with tuberculosis, any type of untreated infection, or recent surgical operation or injury to the nose or mouth (i.e. within 6 months of screening).
Patients using cytochrome P450 3A4 inhibitors (e.g. ritonavir).
Patients with a psychiatric, addictive, or any disorder of which the investigators feel that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire or adherence to study related procedures
Patients being enrolled in other clinical trials within the last 3 months or received any existing or experimental biologics that was not discontinued 5 half-lives or 6 months before V1 if the half-life is unknown.
Patients that underwent allergen immunotherapy less than 3 months prior to V1.
Malignancies (except from insitu basalioma or in situ cervix carcinoma) or any severe comorbidity
Smoking (ex-smokers can participate if quit smoking at least 6 months prior to screening and less than 10 packyears)
Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
Usage of medication which according to the investigators is deemed to interfere with the study safety/procedures/medication as listed in section 5.3.2.1 “prohibited concomitant medication”
Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
Any technical/administrative reason that makes it impossible to randomize the patient in the study
+7 more criteria

A phase IV, randomized double blinded placebo-controlled study on the barrier restoring capacity of Dupilumab in type 2 airway disease: CRSwNP

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations