Trial record 1 of 1 for:
LPS16677
A Phase 4, Randomized, Double-blind, Placebo-controlled,Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma (MORPHEO)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04502862 |
Recruitment Status :
Completed
First Posted : August 6, 2020
Last Update Posted : January 26, 2024
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
Tracking Information | |||||
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First Submitted Date ICMJE | August 4, 2020 | ||||
First Posted Date ICMJE | August 6, 2020 | ||||
Last Update Posted Date | January 26, 2024 | ||||
Actual Study Start Date ICMJE | August 10, 2020 | ||||
Actual Primary Completion Date | October 3, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in sleep disturbance score in Asthma Sleep Disturbance Questionnaire [ Time Frame: Baseline to Week 12 ] Change from baseline to Week 12 in sleep disturbance score using the Asthma Sleep Disturbance Questionnaire
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Phase 4, Randomized, Double-blind, Placebo-controlled,Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma | ||||
Official Title ICMJE | A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma | ||||
Brief Summary | Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives:
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Detailed Description | Study duration per participant will be approximately 16 weeks and up to 29 weeks including up to 5 weeks screening period, a 12-week treatment period and up to 12 weeks post-treatment follow-up period or until the participant switches to commercialized dupilumab (or other biologic product), whichever comes first. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Interim analysis for sample size re-estimation Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE | Asthma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
202 | ||||
Original Estimated Enrollment ICMJE |
260 | ||||
Actual Study Completion Date ICMJE | November 10, 2023 | ||||
Actual Primary Completion Date | October 3, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Argentina, Canada, Germany, Italy, Netherlands, Portugal, Russian Federation, Spain, Ukraine, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04502862 | ||||
Other Study ID Numbers ICMJE | LPS16677 U1111-1249-6054 ( Registry Identifier: ICTRP ) 2020-001217-20 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Sanofi | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Sanofi | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Regeneron Pharmaceuticals | ||||
Investigators ICMJE |
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PRS Account | Sanofi | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |