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Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma (VENTURE)

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ClinicalTrials.gov Identifier: NCT02528214
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.

Secondary Objectives:

  • To evaluate the safety and tolerability of dupilumab.
  • To evaluate the effect of dupilumab in improving patient-reported outcomes.
  • To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.

Condition or disease Intervention/treatment Phase
Asthma Drug: Dupilumab SAR231893 (REGN668) Drug: Placebo Drug: asthma controller therapies (including prednisone/prednisolone) Phase 3

Detailed Description:

The total study duration per patient will be up to 46 weeks, consisting of a screening period of 3 to up to 8 weeks (up to 10 weeks for patients who experience a clinically significant asthma exacerbation during the screening period), a randomized treatment period of up to 24 weeks, and a post-treatment period of 12 weeks.

Patients who complete treatment can be considered for eligibility into the long term extension study LTS12551.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma
Study Start Date : October 15, 2015
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : November 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab
Dupilumab every 2 weeks (loading dose with a double dose) added to current controller medications
Drug: Dupilumab SAR231893 (REGN668)
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: asthma controller therapies (including prednisone/prednisolone)
Pharmaceutical form:aerosol, capsules, tablets Route of administration: inhaled, oral

Placebo Comparator: Placebo
Placebo (for dupilumab) every 2 weeks (loading dose with a double dose) added to current controller medications
Drug: Placebo
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: asthma controller therapies (including prednisone/prednisolone)
Pharmaceutical form:aerosol, capsules, tablets Route of administration: inhaled, oral




Primary Outcome Measures :
  1. Percentage reduction in OCS dose while maintaining asthma control [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. Proportion of patients achieving a reduction of 50% or greater in their OCS dose compared with baseline while maintaining asthma control [ Time Frame: Baseline, Week 24 ]
  2. Absolute reduction of OCS dose compared with the baseline dose while maintaining asthma control [ Time Frame: Baseline, Week 24 ]
  3. Proportion of patients achieving a reduction of OCS dose to <5 mg/ day while maintaining asthma control [ Time Frame: Week 24 ]
  4. Proportion of patients no longer requiring OCS while maintaining asthma control [ Time Frame: Week 24 ]
  5. Proportion of patients achieving their maximum possible OCS dose reduction while maintaining asthma control [ Time Frame: Baseline, Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

o Adult and adolescent (12 years of age or older) patients with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2014 guidelines and the following criteria:

  • Patients with severe asthma and a well-documented, regular prescribed treatment of maintenance corticosteroids in the 6 months prior to Visit 1 and using a stable OCS dose (ie, no change of OCS dose) for 4 weeks prior to Visit 1. Patients must be taking 5 to 35 mg/day of prednisone/prednisolone, or the equivalent, at Visit 1 and at the Randomization visit. In addition, the patient must agree to switch to study-required prednisone/prednisolone as their OCS and use it per protocol for the duration of the study.
  • Existing treatment with high-dose inhaled corticosteroid (ICS; >500 mcg total daily dose of fluticasone propionate or equivalent) in combination with a second controller (ie, long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA]) for at least 3 months with a stable dose of ICS for ≥1 month prior to Visit 1. In addition, patients requiring a third controller for their asthma are considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥ 1 month prior to Visit 1.
  • A forced expiratory volume in 1 second (FEV1) <80% of predicted normal for adults and ≤90% of predicted normal for adolescents at Visit 1.
  • Evidence of asthma as documented by either: reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg (2 to 4 inhalations of albuterol/salbutamol or levalbuterol/levosalbutamol, or of a nebulized solution of albuterol/salbutamol or levalbuterol/levosalbutamol, if considered as a standard office practice) before randomization or documented in the 12 months prior to Visit 1 OR airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction [PC20] of <8 mg/mL) documented in the 12 months prior to Visit 1.

Exclusion criteria:

  • Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are ≥18 years of age).
  • Patients who weigh <30.0 kg.
  • Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, allergic bronchopulmonary aspergillosis, cystic fibrosis) which may impair lung function.
  • Clinical evidence or imaging (eg, chest X-ray, computed tomography, magnetic resonance imaging) within 12 months of Visit 1 with clinically significant findings of lung disease(s) other than asthma, as per local standard of care.
  • A patient who experiences a deterioration of asthma that results in emergency treatment or hospitalization within 4 weeks of Screening Visit 1.
  • A patient who requires 12 puffs or more of rescue medication on any 1 day in the week prior to Visit 1.
  • A subject who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to screening.
  • Current smoker or cessation of smoking within 6 months prior to Visit 1.
  • Previous smoker with a smoking history >10 pack-years.
  • Comorbid disease that might interfere with the evaluation of the investigational medicinal product.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528214


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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02528214     History of Changes
Other Study ID Numbers: EFC13691
2015-001573-40 ( EudraCT Number )
U1111-1170-7152 ( Other Identifier: UTN )
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisone
Prednisolone
Antibodies, Monoclonal
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors