Controlled Clinical Study of Dupilumab in Patients with Nasal Polyps

Phase 1

• Conditions: Bilateral nasal polyposis; MedDRA version: 19.0Level: PTClassification code 10028756Term: Nasal polypsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2015-001314-10-SE
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-14
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

-Patients with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or have a medical contraindication/intolerance to SCS, and/or had prior surgery for NP at the screening visit, have:

-An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).

-Ongoing symptoms (for at least 8 weeks before V1) of nasal congestion/ blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at time of randomization (V2), and another symptom such as loss of smell, rhinorrhea (anterior/posterior).

-Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 655
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

- Patients <18 years of age.

- Patient who has been previously treated in dupilumab studies.

- Patient who has taken:

-Biologic therapy/ systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 2 months before V1 or 5 half-lives, whichever is longer.

-Any experimental monoclonal antibody (mAB) within 5 half-lives or within 6 months before V1 if the half-life is unknown.

-Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to V1.

-Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at least 30 days prior to V1.

- Initiation of allergen immunotherapy within 3 months prior to V1 or a plan to begin therapy or change its dose during the run-in period or the randomized treatment period.

- Patients who have undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months before V1.

- Patients who have had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.

- Patients with conditions/concomitant diseases making them non evaluable at V1 or for the primary
efficacy endpoint such as:

-Antrochoanal polyps,

-Nasal septal deviation that would occlude at least one nostril,

-Acute sinusitis, nasal infection or upper respiratory infection,

-Ongoing rhinitis medicamentosa,

-Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener’s granulomatosis),Young’s syndrome, Kartagener’s syndrome or other dyskinetic ciliary
syndromes, concomitant cystic fibrosis,

-Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis.

- Patients with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc.).

- Patients with forced expiratory volume (FEV1) 50% or less (of predicted normal).

- Patients receiving concomitant treatment prohibited in the study.

- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.

- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.

- Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit.

- Active chronic or acute infection requiring systemic treatment within 2 weeks before the Baseline visit.

- Known or suspected history of immunosuppression.

- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

- Women unwilling to use adequate birth control, if of reproductive potential and sexually active.

Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.

Study & Design

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