Status:
COMPLETED
An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Nasal Polyps
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Primary Objective: To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison t...
Detailed Description
Screening period (4 weeks) + Randomized Treatment Period (16 weeks) + Post-Treatment Period (16 weeks) = 36 weeks. To ensure at least 28 participants with co-morbid asthma needed for subgroup analysi...
Eligibility Criteria
Inclusion
- Inclusion criteria: participants with:
- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) despite completion of a prior intranasal corticosteroid (INCS) treatment for at least 8 weeks before screening.
- Presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell.
- Exclusion criteria:
- Participants \<18 or \>65 years of age.
- Sinonasal outcome test (SNOT-22) \<7.
- Participants who had taken other investigational drugs or prohibited therapy for this study within 2 months before screening or 5 half-lives, whichever was longer:
- Burst of systemic corticosteroids within the 2 months before screening or were scheduled to receive systemic corticosteroids during the study period for another condition
- INCS drops within 1 month prior to screening
- Monoclonal antibody (mAB) and immunosuppressive treatment
- Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days of Visit 1
- Leukotriene antagonists/modifiers unless participant was on a continuous treatment for at least 30 days prior to Visit 1.
- Participants who had undergone any nasal surgery (including polypectomy) within 6 months before screening or have had more than 5 sinonasal surgeries in the past of which maximal 2 were surgeries changing the lateral wall structure of the nose.
- Participants with asthma having:
- Forced Expiratory Volume (FEV1) ≤ 60%, or .Asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for \>24 hours for treatment of asthma, within 3 months prior to screening or were on a dose of greater than 1000 microgram (mcg) fluticasone or an equivalent INCS.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01920893
Start Date
August 1 2013
End Date
November 1 2014
Last Update
June 26 2017
Active Locations (14)
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1
Investigational Site Number 840014
Rolling Hills Estates, California, United States, 90274
2
Investigational Site Number 840015
Denver, Colorado, United States, 80230
3
Investigational Site Number 840013
Boston, Massachusetts, United States, 02114
4
Investigational Site Number 840002
Lake Oswego, Oregon, United States, 97035