Dupilumab in CRSsNP (Liberty CRSsNP ORION)

  • STATUS
    Recruiting
  • End date
    May 30, 2024
  • participants needed
    240
  • sponsor
    Sanofi
Updated on 22 January 2022
ct scan
antibiotics
congestion
obstruction
nasal congestion
rhinorrhea
asthma
acute sinusitis
sinusitis
sinus surgery
facial pain

Summary

Primary Objective:

Part A and B: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan and sinus total symptom score (sTSS) compared to placebo

Secondary Objectives:

Part A

  • To evaluate the efficacy of dupilumab as assessed by the reduction at Week 52 in sinus opacification on CT scan and total symptom score (sTSS) compared to placebo
  • To evaluate the efficacy of dupilumab in improving CRSsNP symptoms at Weeks 24 and 52 compared to placebo
  • To evaluate the effect of dupilumab on health related quality of life at Weeks 24 and 52 (HRQoL) compared to placebo
  • To evaluate the effect of dupilumab on CRSsNP overall disease severity at Weeks 24 and 52 compared to placebo
  • To evaluate the effect of dupilumab at Weeks 24 and 52 in the subgroups of participants with comorbid asthma compared to placebo
  • To evaluate the ability of dupilumab to reduce the incidence of participants with CRSsNP worsening/acute sinusitis who require treatment with antibiotics, systemic corticosteroids (SCS) or sinus surgery compared to placebo
  • To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP and type 2 inflammation
  • To evaluate the effect of dupilumab in the subgroup of participants with screening blood eosinophils count ≥300 cells/mm3 compared to placebo
  • To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo
  • To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo
  • Assessment of immunogenicity to dupilumab over time compared to placebo

Part B

  • To evaluate the efficacy of dupilumab in improving CRSsNP symptoms at Week 24 compared to placebo in patients
  • To evaluate the effect of dupilumab on health related quality of life (HRQoL) compared to placebo
  • To evaluate the effect of dupilumab on CRSsNP overall disease severity compared to placebo
  • To evaluate the effect of dupilumab in the subgroups of participants with comorbid asthma compared to placebo
  • To evaluate the ability of dupilumab to reduce the incidence of participants with CRSsNP worsening/acute sinusitis who require treatment with antibiotics, SCS, or sinus surgery compared to placebo
  • To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP and type 2 inflammation
  • To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo
  • To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo
  • Assessment of immunogenicity to dupilumab over time compared to placebo

Description

The duration of study for each participant will include 2-4 weeks of screening period, randomized investigational medicinal product (IMP) intervention period (52 weeks in Part A and 24 weeks in Part B) and 12 weeks of follow-up period.

Details
Condition Chronicrhinosinusitis Without Nasalpolyps, Sinusitis, Chronic Sinusitis, Sinus Disorder, Respiratory Disorder
Treatment Placebo, Dupilumab SAR231893
Clinical Study IdentifierNCT04678856
SponsorSanofi
Last Modified on22 January 2022

Eligibility

Yes No Not Sure

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
Prior sinonasal surgery for CRS
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

Exclusion Criteria

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 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 intranasal corticosteroids (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
Biologic therapy/systemic immunosuppressant to treat inflammatory disease or
autoimmune disease within 5 half-lives prior to Visit 1
Any investigational mAb within 5 half-lives prior to Visit 1
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)
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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