Dupilumab in CRSsNP

Phase 1

• Conditions: Chronic rhinosinusitis without nasal polyposis; MedDRA version: 20.1Level: PTClassification code 10009137Term: Chronic sinusitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-003117-35-PT
• Lead Sponsor: Sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-23
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 437

Inclusion Criteria

- Part A only: Participant must be at least 18 years of age at the time of
signing the informed consent form (ICF).
- Part B only: Participant must be at least 12 years of age (or the
minimum legal age for
adolescents in the country of the investigational site) at the time of
signing the ICF.
- Participants must have bilateral inflammation of paranasal sinuses in
CT scan with LMK =8 and bilateral ethmoid opacification before
randomization.
- Participants must have ongoing symptoms of loss of smell and
rhinorrhea (anterior/posterior) of any severity, with or without facial
pain/pressure for at least 12 consecutive weeks by Visit 1.
- Participants must have ongoing symptoms of nasal congestion
(NC)/obstruction at least 12 consecutive weeks before Visit 1 and a NC
score of = 2 at Visit 1 (day score) and Visit 2 (weekly average score).
- Participants must have sTSS (NC, rhinorrhea, facial pain/pressure) =5
at Visit 1 (day score) and Visit 2 (weekly average score).
- Participants must have one of the 2 following features:
o Prior sinonasal surgery (see note at end of section 5.2 for definitions
of sinonasal surgery) for CRS,
o Comorbid asthma,
o Treatment with SCS therapy for CRS as defined by any dose and
duration within the prior 2 years before screening (Visit 1) or
intolerance/contraindication to SCS.
- For Part B only: participants who have a blood eosinophil count =300
cells/mm3 at Screening
- Body weight =30 kg.
Are the trial subjects under 18? yes
Number of subjects for this age range: 9
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 371
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

Participants are excluded from the study if any of the following criteria
apply:
- Patients with nasal conditions/concomitant nasal diseases such as
nasal polyposis in endoscopy at Visit 1 or with history of nasal polyposis
etc., making them non-evaluable at Visit 1 or for the primary efficacy
- Nasal cavity malignant tumor and benign tumors.
- Forced expiratory volume (FEV1) =50% of predicted normal at Visit 1.
- Radiologic suspicion or confirmed invasive or expansive fungal
rhinosinusitis.
- Severe concomitant illness(es) that, in the investigator's judgment,
would adversely affect the patient's participation in the study
- Active tuberculosis or non-tuberculous mycobacterial infection, or a
history of incompletely treated tuberculosis unless documented
adequately treated.
- Diagnosed active endoparasitic infections; suspected or high risk of
endoparasitic infection
- Known or suspected immunodeficiency
- History of malignancy within 5 years before Visit 1, except completely
treated in situ carcinoma of the cervix, and completely treated and
resolved nonmetastatic squamous or basal cell carcinoma of the skin.
- Active chronic or acute infection requiring treatment with systemic
antibiotics, antivirals, or antifungals within 2 weeks before the
Screening Visit 1 or during the screening period.
- History of systemic hypersensitivity or anaphylaxis to dupilumab or any
of its excipients.
- Patients in prior dupilumab clinical trial or have been treated with
commercially available dupilumab within 12 months or who discontinued
dupilumab use due to adverse event.
- Patients who are treated with intranasal corticosteroid drops;
intranasal steroid emitting devices/stents; nasal spray using exhalation
delivery system, such as Xhance™, during screening period.
- Participants on unstable dose of INCS spray 4 weeks prior to Screening
Visit (Visit1) and during screening period.
- Patients who have undergone sinus intranasal surgery (including
polypectomy) within 6 months prior to Visit 1.
- Patients who have taken:
o Biologic therapy/systemic immunosuppressant to treat inflammatory
disease or autoimmune disease within 5 half-lives prior to Visit 1
o Any investigational mAb within 5 half-lives prior to Visit 1
o Anti-IgE therapy (omalizumab) within 4 months prior to Visit 1.
-Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit
1
- Leukotriene antagonists/modifiers unless patient is on a continuous
treatment for at least 30 days prior to Visit 1.
- Initiation of allergen immunotherapy within 3 months prior to Visit 1 or
a plan to begin therapy or change its dose during the screening or
treatment period.
- Patients received SCS during screening period(between Visit 1 and Visit
2).
- Either intravenous immunoglobulin therapy and/or plasmapheresis
within 30 days prior to Screening Visit (Visit 1).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified