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An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01920893
First received: August 8, 2013
Last updated: June 7, 2017
Last verified: June 2017
  Purpose

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 to placebo.

Secondary Objectives:

To evaluate effect of dupilumab with regards to:

  • symptoms of sinusitis,
  • sinus computed tomography (CT) scan,
  • NPS in the sub-group of participants with co-morbid asthma,
  • Safety and tolerability.

Condition Intervention Phase
Nasal Polyps Drug: Placebo (for dupilumab) Drug: Dupilumab Drug: Mometasone furoate nasal spray Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 [ Time Frame: Baseline, Week 16 ]
    NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps.


Secondary Outcome Measures:
  • Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma [ Time Frame: Baseline, Week 16 ]
    NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps.

  • Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 [ Time Frame: Baseline, Week 16 ]
    Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea [runny nose], posterior rhinorrhea [post nasal drip], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms.

  • Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16 [ Time Frame: Baseline, Week 16 ]
    Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome.

  • Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16 [ Time Frame: Baseline, Week 16 ]
    NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute.

  • Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16 [ Time Frame: Baseline, Week 16 ]
    UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss.

  • Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score [ Time Frame: Baseline, Week 16 ]
    CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status.

  • Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease [ Time Frame: Baseline, Week 16 ]
    CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease.

  • Time to First Response in NPS: Kaplan-Meier Estimate at Week 16 [ Time Frame: Baseline to Week 16 ]
    The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as >=1 point reduction from baseline score); for participants without NPS >=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics.

  • Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16 [ Time Frame: Baseline, Week 16 ]
    The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90.


Enrollment: 60
Study Start Date: August 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to Mometasone furoate nasal spray (MFNS).
Drug: Placebo (for dupilumab)
Solution for injection; Subcutaneous injection.
Drug: Mometasone furoate nasal spray
Nasal spray, 2 actuations in each nostril twice daily.
Other Name: NASONEX®
Experimental: Dupilumab 300 mg QW
Dupilumab, 2 Subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
Drug: Dupilumab
Solution for injection; Subcutaneous injection.
Other Names:
  • SAR231893
  • REGN668
Drug: Mometasone furoate nasal spray
Nasal spray, 2 actuations in each nostril twice daily.
Other Name: NASONEX®

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 analysis, recruitment of NP participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920893

Locations
United States, California
Investigational Site Number 840014
Rolling Hills Estates, California, United States, 90274
United States, Colorado
Investigational Site Number 840015
Denver, Colorado, United States, 80230
United States, Massachusetts
Investigational Site Number 840013
Boston, Massachusetts, United States, 02114
United States, Oregon
Investigational Site Number 840002
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
Investigational Site Number 840009
Pittsburgh, Pennsylvania, United States, 15213
Belgium
Investigational Site Number 056001
Gent, Belgium, 9000
Investigational Site Number 056002
Leuven, Belgium, 3500
Spain
Investigational Site Number 724001
Barcelona, Spain, 08036
Investigational Site Number 724003
Faitanar, Spain, 46014
Investigational Site Number 724002
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 724005
Jerez De La Frontera, Spain, 11407
Investigational Site Number 724004
Madrid, Spain, 28040
Sweden
Investigational Site Number 752001
Stockholm, Sweden, 14186
Investigational Site Number 752002
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01920893     History of Changes
Other Study ID Numbers: ACT12340
2013-001803-35 ( EudraCT Number )
U1111-1130-6475 ( Other Identifier: UTN )
Study First Received: August 8, 2013
Results First Received: April 27, 2017
Last Updated: June 7, 2017

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 18, 2017