AsthmaPhase 4MORPHEONCT04502862
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
A Phase 4 study testing SAR231893 in people with Asthma, run by Sanofi at 55 sites in 11 countries.
Trial summary
Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: To evaluate the effect of dupilumab on additional participant reported sleep outcomes To evaluate the effect of dupilumab on objective sleep assessment To evaluate the effect of dupilumab on asthma symptoms To evaluate the effect of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- SAR231893
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 55 sitesin 11 countries
- Study dates
- 10 Aug 2020to 10 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020 Guidelines for ≥12 months treated with medium to high dose inhaled corticosteroid (ICS) and a second controller (ie, long-acting beta agonist, leukotriene receptor antagonist). A third controller is allowed but not mandatory. The dose regimen should be stable for at least 1 month before the study and during the screening period
- History of at least one severe asthma exacerbation within 1 year prior to screening. Severe exacerbation is defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids (oral or injectable)
- Eosinophils ≥150 cells/μL and fractional exhaled nitric oxide (FeNO) ≥25 ppb during screening, prior to randomization
- NOTES:
- Historical values of blood eosinophil count meeting the eligibility criterion measured within 6 months prior to screening Visit 1 in the absence of oral corticosteroid (OCS) treatment are allowed
- FeNO value to be checked for eligibility at Visit 2 as well
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- Asthma control questionnaire (ACQ)-5 ≥2.5 at screening Visit 1 and Visit 2, prior to randomization
- Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) ≤ 80% of predicted normal during screening and at Visit 2, prior to randomization
- Exhibit bronchodilator reversibility (≥12% and 200 mL improvement in FEV1 post short-acting beta agonist administration) during screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 6 months prior to screening Visit 1
- Weekly average nocturnal awakenings due to asthma symptoms in the week prior to screening Visit 1 is ≥1
Who cannot join
- Current smoker
- Former smoker for 10 years with a smoking history of >10 pack-years
- Severe asthma exacerbation during screening, prior to randomization
- History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome)
- History of or current evidence of clinically significant non-respiratory diseases that in the opinion of the investigator may interfere with the aims of the study or put the participant at undue risk
- Active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would be performed on a country by country basis, according to local guidelines if required by Regulatory Authorities or ethics boards
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- Diagnosed active endoparasitic infection; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
- History of human immunodeficiency (HIV) infection or positive HIV test at screening Visit 1
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before screening
- Known or suspected immunodeficiency including history of invasive opportunistic infections, despite infection resolution
- Current evidence of clinically significant oncological disease
- History of systemic hypersensitivity or anaphylaxis to any biologic therapy
- Severe uncontrolled depression
- Sleep disturbances not related to asthma, including sleep apnea, hypersomnia, or insomnia secondary to chronic pain, atopic dermatitis (AD), COPD or other conditions
- Participant who works night shift (ie, any work between 8 pm and 6 am)
- Erratic sleep habits, as determined by the Investigator
- Restless leg syndrome or periodic limb movement disorder
- Chronic treatment with oral corticosteroid (OCS) for more than 2 weeks before screening Visit 1
- Participant taking sedative, anxiolytic, or hypnotic treatments, including melatonin, within 3 months before randomization
- Participant taking systemic sedative antihistamines (excluding newer generations of antihistamines) or theophylline
- Current treatment with antidepressants, lipophilic beta blockers, clonidine, opioids, or other medications known to interfere with sleep and may confound the study assessments, as determined by the Investigator
- Participant who has taken biologic therapy (including dupilumab)/systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc) within 2 months or 5 half-lives before screening Visit 1, whichever is longer
- Treatment with live (attenuated) vaccine within 4 weeks before screening Visit 1
- NOTE: For participants who have vaccination with live, attenuated vaccines planned during the course of the study (based on national vaccination schedule/local guidelines), it will be determined, after consultation with a physician, whether the administration of vaccine can be postponed until after the end of the study, (i.e. after the 12 week follow-up period off-treatment or until the participant switches to commercialized dupilumab or other biologic product, whichever comes first), or preponed to before the start of the study without compromising the health of the participant:
- Participant for whom administration of live (attenuated) vaccine can be safely postponed would be eligible to enroll into the study
- Participant who have their vaccination preponed can enroll in the study only after a gap of 4 weeks following administration of the vaccine
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
55 sites in 11 countries.
55 sites in 11 countries
United States12 sites
Kern Allergy and Medical Research. Inc. Site Number : 8400003
Bakersfield, California, 93301
The Asthma and Allergy Center Site Number : 8400010
Bellevue, Nebraska, 68123
TTS Research Site Number : 8400006
Boerne, Texas, 78006
National Allergy and Asthma Research, LLC Site Number : 8400008
Charleston, South Carolina, 29407
Asthma and Allergy Associates, PC Site Number : 8400011
Colorado Springs, Colorado, 80907
Todd Astor MD Site Number : 8400016
Culver City, California, 90230
OK Clinical Research LLC Site Number : 8400005
Edmond, Oklahoma, 73034
Southern California Institute for Respiratory Diseases Site Number : 8400009
Los Angeles, California, 90048
Velocity Clinical Research, Medford Site Number : 8400007
Medford, Oregon, 97504
Allergy & Asthma Specialists, PSC Site Number : 8400004
Owensboro, Kentucky, 42301
Allergy & Asthma Associates of Santa Clara Valley Site Number : 8400001
San Jose, California, 95117
Sarasota Clinical Research Site Number : 8400012
Sarasota, Florida, 34239
Germany6 sites
Investigational Site Number : 2760002
Berlin, 10787
Investigational Site Number : 2760005
Frankfurt am Main, 60596
Investigational Site Number : 2760003
Hanover, 30173
Investigational Site Number : 2760001
Koblenz, 56068
Investigational Site Number : 2760004
Leipzig, 04347
Investigational Site Number : 2760006
Lübeck, 23552
Russia6 sites
Investigational Site Number : 6430001
Moscow, 115093
Investigational Site Number : 6430002
Moscow, 115280
Investigational Site Number : 6430006
Moscow, 115478
Investigational Site Number : 6430005
Moscow, 117546
Investigational Site Number : 6430007
Saint Petersburg, 193231
Investigational Site Number : 6430004
Saint Petersburg, 194354
Ukraine6 sites
Investigational Site Number : 8040002
Ivano-Frankivsk, 76018
Investigational Site Number : 8040006
Ivano-Frankivsk, 76018
Investigational Site Number : 8040003
Kharkiv, 61166
Investigational Site Number : 8040008
Kyiv, 01023
Investigational Site Number : 8040007
Kyiv, 01033
Investigational Site Number : 8040005
Vinnytsia, 21001
Argentina5 sites
Investigational Site Number : 0320002
Buenos Aires, C1121ABE
Investigational Site Number : 0320003
CABA, Buenos Aires, C1414AIF
Investigational Site Number : 0320001
CABA, Buenos Aires, C1425FVH
Investigational Site Number : 0320004
Rosario, Santa Fe Province, S2000DEJ
Investigational Site Number : 0320005
Rosario, Santa Fe Province, S2002OJP
Portugal5 sites
Investigational Site Number : 6200001
Aveiro, 3810-501
Investigational Site Number : 6200007
Guimarães, 4810-061
Investigational Site Number : 6200006
Lisbon, 1769
Investigational Site Number : 6200003
Matosinhos Municipality, 4464-513
Investigational Site Number : 6200004
Porto, 4202-451
Canada4 sites
Investigational Site Number : 1240012
Ajax, Ontario, L1S 2J5
Investigational Site Number : 1240009
Québec, G1G 3Y8
Investigational Site Number : 1240005
Toronto, Ontario, M9V 4B4
Investigational Site Number : 1240008
Windsor, N8X 5A6
Italy3 sites
Investigational Site Number : 3800006
Monserrato, Cagliari, 09042
Investigational Site Number : 3800001
Orbassano, Torino, 10043
Investigational Site Number : 3800005
Reggio Emilia, 42123
Netherlands3 sites
Investigational Site Number : 5280005
Arnhem, 6815 AD
Investigational Site Number : 5280001
Breda, 4818 CK
Investigational Site Number : 5280002
Leeuwarden, 8934 AD
Spain3 sites
Investigational Site Number : 7240001
Lugo / Lugo, Galicia [Galicia], 27003
Investigational Site Number : 7240005
Madrid, 28006
Investigational Site Number : 7240002
Valencia, Valenciana, Comunidad, 46017
United Kingdom2 sites
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, CB2 2QQ
Investigational Site Number : 8260002
London, London, City of, EC1M 6BQ
About this study
Primary Objective:
To assess the effect of dupilumab on sleep
Secondary Objectives:
- To evaluate the effect of dupilumab on additional participant reported sleep outcomes
- To evaluate the effect of dupilumab on objective sleep assessment
- To evaluate the effect of dupilumab on asthma symptoms
- To evaluate the effect of dupilumab on lung function
- To evaluate the safety of dupilumab
Read the detailed description
Study duration per participant was 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 switched to commercialized dupilumab (or other biologic product), whichever came first.
- Conditions
- Asthma
- Being tested
- SAR231893, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR231893Drug
Also called Dupixent
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
PlaceboDrug
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Participants received a loading dose of 400 mg of dupilumab (2 injections × 200 mg) SC on Day 1, followed by 200 mg Q2W for 12 weeks. Receives: Drug: SAR231893 |
| Placebo | Placebo comparator | Participants received an initial loading dose of matching placebo (2 injections of placebo) SC on Day 1, followed by 1 injection of placebo Q2W for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in Sleep Disturbance Score Using the Asthma Sleep Disturbance Questionnaire (ASDQ)
The ASDQ is a participant-reported outcome (PRO) measure designed to assess the impact of asthma on participants' sleep. Participants were instructed to record the severity of the disturbance of their sleep due to asthma as: 0 = slept through the night, no asthma symptoms; 1 = slept well, no night time awakenings because of asthma, but some asthma symptoms in the morning; 2 = woke up once because of asthma (may or may not include early awakening); 3 = woke up several times because of asthma (may or may not include early awakening) and 4 = bad night, awake most of the night because of asthma. The participants recorded their sleep disturbance in an electronic diary, once a day upon awakening. Total scores ranges between 0 to 4 with 0 indicating no impact of asthma on sleep and 4 indicating higher impact of asthma on sleep. Higher scores indicated worse outcomes. Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Measured: Baseline (Day -6 to Day 1) up to Week 12
Secondary outcomes (11)
Change From Baseline to Week 12 on the Number of Nocturnal Awakenings (Sleep Diary)
Sleep diary is used to assess adult sleep disturbance due to asthma. Number of nocturnal awakenings was determined based on answer on question from sleep diary: "Approximately how many times did you wake up last night (not including when you woke up for the day today)?" Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Measured: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a Scale
PROMIS sleep-related impairment eight-term 8a scale was administered to assess impact of sleep-related impairment during waking hours. The questionnaire focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. It assesses sleep-related impairment over the past 7 days. Each item is rated on a 5-point scale (1 = not at all; 2 = a little bit; 3 = somewhat; 4 = quite a bit; and 5 = very much) with a raw score from 8 to 40 with higher scores indicating greater sleep impairment. PROMIS T-score is presented which rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Possible range for T-score=30 to 80; higher scores=greater severity of sleep impairment. Baseline=last available valid (non-missing) value up to and including the day of first dose of investigational medicinal product (IMP).
Measured: Baseline (Day 1) up to Week 12
Change From Baseline to Week 12 in Sleep Quality (Sleep Diary)
Sleep diary is used to assess adult sleep disturbance due to asthma. Sleep quality was assessed on a 11-point scale which ranged from 0 (worst possible sleep) to 10 (best possible sleep); higher scores indicated better outcomes. Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Measured: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in Restorative Sleep (Sleep Diary)
Sleep Diary is used to assess adult sleep disturbance due to asthma. Question about restorative sleep asks participants to recall "when they got up for the day today". Restorative sleep was assessed on a 11-point scale which ranged from 0 (worst possible sleep) to 10 (best possible sleep); higher scores indicated better outcomes. Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Measured: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in Wake After Sleep Onset (WASO) (Sleep Diary)
Sleep Diary is used to assess adult sleep disturbance due to asthma. WASO was calculated as time awake after initial sleep onset but before the final awakening. Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Measured: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in WASO Based on Actigraphy Data
Wrist actigraphy is a procedure that records and integrates occurrence and degree of limb movement activity over an extended recording period. The signals generated by wrist movement are sensed by a tiny microcomputer contained within watch and translated into activity counts. Algorithms have been developed to translate these activity counts or "epochs" (or "periods") that correspond to times when a person is likely to be asleep or wake. Actigraph was worn on wrist of non-dominant hand to provide estimates of duration, timing and patterns of sleep in study participants. After the watch data were scored by a selected expert center, a number of summary measurements were generated for each participant, including WASO. Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1.
Measured: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in Asthma Daytime Symptom Diary (ADSD)
The ADSD is a PRO measure designed to measure asthma symptoms in adult and adolescent (12 years of age and older) participants diagnosed with mild to severe asthma. ADSD assesses asthma severity based on participant self-report of asthma core symptoms, i.e., difficulty breathing, wheezing, shortness of breath, chest tightness, chest pain, and cough. Participants were asked to complete the ADSD every night before they go to bed, thinking about their asthma symptoms today, from when they got up this morning until now. ADSD is composed of 6 items rated using an 11-point NRS that ranges from 0 = None to 10 = as bad as you can imagine. The total score was calculated by averaging all 6 items and therefore the score ranged from 0 to 10. Higher scores indicated worse outcomes. Baseline value was average of the data from Day -7 to Day -1.
Measured: Baseline (Day -7 to Day -1) up to Week 12
Change From Baseline to Week 12 in Asthma Nighttime Symptom Diary (ANSD)
The ANSD is a PRO measure designed to measure asthma symptoms in adult and adolescent (12 years of age and older) participants diagnosed with mild to severe asthma. ANSD assesses asthma severity based on participant self-report of asthma core symptoms, i.e., difficulty breathing, wheezing, shortness of breath, chest tightness, chest pain, and cough. Participants were asked to complete the ANSD when getting up, thinking about their asthma symptoms last night from when they went to bed until now. ANSD is composed of 6 items rated using an 11-point NRS that ranges from 0 = None to 10 = as bad as you can imagine. The total score was calculated by averaging all 6 items and therefore the score ranged from 0 to 10. Higher scores indicated worse outcomes. Baseline value was average of the data from Day -6 to Day -1.
Measured: Baseline (Day -6 to Day -1) up to Week 12
Change From Baseline to Week 12 in Pre-Bronchodilator Forced Expiratory Volume (Pre-BD FEV1)
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. For pre-BD FEV1, spirometry was performed before IMP administration and after withholding the standard of care asthma treatment which was verified before performing the measurements. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
Measured: Baseline (Day 1) up to Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events Of Special Interest (TEAESIs)
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs: AEs that developed or worsened or became serious during TEAE period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 98 days or until participant switches to commercialized dupilumab or other biologics. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. AESI: AE (serious or nonserious) of scientific and medical concern specific to Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor is required.
Measured: From first dose of study drug (Day 1) up to 12 weeks after last dose of study drug, approximately 30 weeks
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and weight. Criteria for PCSA: SBP: ≤95 millimeters of mercury (mmHg) and decrease from baseline ≥20 mmHg, ≥160 mmHg and increase from baseline ≥20 mmHg; DBP: ≤45 mmHg and decrease from baseline ≥10 mmHg, ≥ 110 mmHg and increase from baseline ≥ 10 mmHg; HR: ≤ 50 beats per minute (bpm) and decrease from baseline ≥ 20 bpm, ≥120 bpm and increase from baseline ≥ 20 bpm; Weight: ≥ 5% increase from baseline, ≥5% decrease from baseline.
Measured: From first dose of study drug (Day 1) up to 12 weeks after last dose of study drug, approximately 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start10 Aug 2020
- Primary completion3 Oct 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interim analysis for sample size re-estimation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502862
- Sponsor's protocol ID
- LPS16677
- Other IDs
- U1111-1249-6054, 2020-001217-20
- Acronym
- MORPHEO
- Status last verified
- Dec 2024
- First submitted
- 4 Aug 2020
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Maspero JF, Gupta A, Schmidt O, Perez de Llano LA, Martinez Moragon E, Knolle M, Pfeffer PE, Ricciardolo FL, van der Sar-van der Brugge S, Lopes C, Ostrovskyy M, Dobrianskyi D, Cole J, Wachtel A, Zhang M, Berthou B, Gall R, Awad H. Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Moderate-to-Severe Asthma, Type 2 Inflammation, and Nocturnal Awakenings: The MORPHEO Randomized Controlled Trial. J Investig Allergol Clin Immunol. 2026 Jun 29:0. doi: 10.18176/jiaci.1160. Online ahead of print.
PubMed 42370853
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04502862
- Acronym / sponsor ID
- MORPHEO / LPS16677
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To assess the effect of dupilumab on sleep
Secondary Objectives:
- To evaluate the effect of dupilumab on additional participant reported sleep outcomes
- To evaluate the effect of dupilumab on objective sleep assessment
- To evaluate the effect of dupilumab on asthma symptoms
- To evaluate the effect of dupilumab on lung function
- To evaluate the safety of dupilumab
Detailed description
Study duration per participant was 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 switched to commercialized dupilumab (or other biologic product), whichever came first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interim analysis for sample size re-estimation
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: SAR231893Participants received a loading dose of 400 mg of dupilumab (2 injections × 200 mg) SC on Day 1, followed by 200 mg Q2W for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received an initial loading dose of matching placebo (2 injections of placebo) SC on Day 1, followed by 1 injection of placebo Q2W for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020 Guidelines for ≥12 months treated with medium to high dose inhaled corticosteroid (ICS) and a second controller (ie, long-acting beta agonist, leukotriene receptor antagonist). A third controller is allowed but not mandatory. The dose regimen should be stable for at least 1 month before the study and during the screening period
- History of at least one severe asthma exacerbation within 1 year prior to screening. Severe exacerbation is defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids (oral or injectable)
- Eosinophils ≥150 cells/μL and fractional exhaled nitric oxide (FeNO) ≥25 ppb during screening, prior to randomization
- Asthma control questionnaire (ACQ)-5 ≥2.5 at screening Visit 1 and Visit 2, prior to randomization
- Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) ≤ 80% of predicted normal during screening and at Visit 2, prior to randomization
Key exclusion criteria (27 listed)
- Current smoker
- Former smoker for 10 years with a smoking history of >10 pack-years
- Severe asthma exacerbation during screening, prior to randomization
- History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome)
- History of or current evidence of clinically significant non-respiratory diseases that in the opinion of the investigator may interfere with the aims of the study or put the participant at undue risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR231893Also: DupixentPharmaceutical form: Solution for injection; Route of administration: Subcutaneous | Drug | Dupilumab |
| PlaceboPharmaceutical form: Solution for injection; Route of administration: Subcutaneous | Drug | Placebo |
Primary outcome
Change From Baseline to Week 12 in Sleep Disturbance Score Using the Asthma Sleep Disturbance Questionnaire (ASDQ)
Time frame: Baseline (Day -6 to Day 1) up to Week 12
The ASDQ is a participant-reported outcome (PRO) measure designed to assess the impact of asthma on participants' sleep. Participants were instructed to record the severity of the disturbance of their sleep due to asthma as: 0 = slept through the night, no asthma symptoms; 1 = slept well, no night time awakenings because of asthma, but some asthma symptoms in the morning; 2 = woke up once because of asthma (may or may not include early awakening); 3 = woke up several times because of asthma (may or may not include early awakening) and 4 = bad night, awake most of the night because of asthma. The participants recorded their sleep disturbance in an electronic diary, once a day upon awakening. Total scores ranges between 0 to 4 with 0 indicating no impact of asthma on sleep and 4 indicating higher impact of asthma on sleep. Higher scores indicated worse outcomes. Baseline was calculated by averaging the data collected/recorded from Day -6 to Day 1.
11 secondary outcomes
Change From Baseline to Week 12 on the Number of Nocturnal Awakenings (Sleep Diary)
Time frame: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a Scale
Time frame: Baseline (Day 1) up to Week 12
Change From Baseline to Week 12 in Sleep Quality (Sleep Diary)
Time frame: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in Restorative Sleep (Sleep Diary)
Time frame: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in Wake After Sleep Onset (WASO) (Sleep Diary)
Time frame: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in WASO Based on Actigraphy Data
Time frame: Baseline (Day -6 to Day 1) up to Week 12
Change From Baseline to Week 12 in Asthma Daytime Symptom Diary (ADSD)
Time frame: Baseline (Day -7 to Day -1) up to Week 12
Change From Baseline to Week 12 in Asthma Nighttime Symptom Diary (ANSD)
Time frame: Baseline (Day -6 to Day -1) up to Week 12
Change From Baseline to Week 12 in Pre-Bronchodilator Forced Expiratory Volume (Pre-BD FEV1)
Time frame: Baseline (Day 1) up to Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events Of Special Interest (TEAESIs)
Time frame: From first dose of study drug (Day 1) up to 12 weeks after last dose of study drug, approximately 30 weeks
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Vital Signs
Time frame: From first dose of study drug (Day 1) up to 12 weeks after last dose of study drug, approximately 30 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42370853Maspero JF, Gupta A, Schmidt O, Perez de Llano LA, Martinez Moragon E, Knolle M, Pfeffer PE, Ricciardolo FL, van der Sar-van der Brugge S, Lopes C, Ostrovskyy M, Dobrianskyi D, Cole J, Wachtel A, Zhang M, Berthou B, Gall R, Awad H. Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Moderate-to-Severe Asthma, Type 2 Inflammation, and Nocturnal Awakenings: The MORPHEO Randomized Controlled Trial. J Investig Allergol Clin Immunol. 2026 Jun 29:0. doi: 10.18176/jiaci.1160. Online ahead of print.
- LPS16677 Plain language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
55 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SAR231893 in people with Asthma, run by Sanofi at 55 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Germany, Russia, Ukraine, Argentina and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 12 in Sleep Disturbance Score Using the Asthma Sleep Disturbance Questionnaire (ASDQ) (time frame: Baseline (Day -6 to Day 1) up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04502862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.