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

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Sanofi

Status and phase

Completed
Phase 2

Conditions

Nasal Polyps

Treatments

Drug: Dupilumab
Drug: Placebo (for dupilumab)
Drug: Mometasone furoate nasal spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT01920893
ACT12340
U1111-1130-6475 (Other Identifier)
2013-001803-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
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).
Treatment:
Drug: Mometasone furoate nasal spray
Drug: Placebo (for dupilumab)
Dupilumab 300 mg QW
Experimental group
Description:
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.
Treatment:
Drug: Mometasone furoate nasal spray
Drug: Dupilumab

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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