Trial Outcomes & Findings for An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis (NCT NCT01920893)

NCT ID: NCT01920893

Last Updated: 2017-06-26

Results Overview

NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2017-06-26

Participant Flow

The study was conducted at 14 sites in 4 countries. A total of 60 participants were randomized between August 2013 and March 2014.

Randomization was stratified according to medical history of asthma (with/without asthma) and by nasal biopsy (biopsy performed,Yes/No). Assignment was done centrally using Interactive Voice/Web Response System in 1:1 ratio (dupilumab:placebo)after 4-week run-in period on Mometasone furoate nasal spray (MFNS) and confirmation of selection criteria.

Participant milestones

Participant milestones
Measure	Placebo 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 MFNS.	Dupilumab 300 mg QW 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.
Overall Study STARTED	30	30
Overall Study Treated (Safety Population)	30	30
Overall Study COMPLETED	23	28
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 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 MFNS.	Dupilumab 300 mg QW 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.
Overall Study Adverse Event	5	2
Overall Study Lack of Efficacy	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=30 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	49.3 years STANDARD_DEVIATION 9.1 • n=5 Participants	47.4 years STANDARD_DEVIATION 9.8 • n=7 Participants	48.4 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Number of participants with asthma Yes	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Number of participants with asthma No	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group allocated by randomization. Here, number analyzed = number of participants with available data for specified time points.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=30 Participants 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.
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 Baseline	5.67 score on a scale Standard Deviation 0.88	5.87 score on a scale Standard Deviation 1.01
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 Week 16	5.39 score on a scale Standard Deviation 1.47	3.97 score on a scale Standard Deviation 1.9
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 Change from baseline at Week 16	-0.26 score on a scale Standard Deviation 1.32	-1.9 score on a scale Standard Deviation 1.76

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants of the ITT population with asthma and with available data at Week 16.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=15 Participants 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.
Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma	0.27 score on a scale Standard Deviation 0.88	-2.4 score on a scale Standard Deviation 2.03

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants from ITT population with data available for symptom score at Week 16.

Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea \[runny nose\], posterior rhinorrhea \[post nasal drip\], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=29 Participants 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.
Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 Post nasal drip	-0.15 score on a scale Standard Deviation 0.59	-0.49 score on a scale Standard Deviation 0.78
Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 Loss of sense of smell	-0.3 score on a scale Standard Deviation 0.6	-1.36 score on a scale Standard Deviation 1.08
Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 Congestion/obstruction	-0.26 score on a scale Standard Deviation 0.7	-0.95 score on a scale Standard Deviation 0.86
Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 Runny nose	-0.1 score on a scale Standard Deviation 0.58	-0.62 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants from ITT population with data available for Rhinosinusitis Symptoms Severity VAS at Week 16.

Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=28 Participants 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.
Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16	-1.84 centimetre (cm) Standard Deviation 3.6	-4.32 centimetre (cm) Standard Deviation 2.75

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants from ITT population with data available for NPIF at Week 16.

NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=29 Participants 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.
Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16 NPIF-Morning	28.81 liter/minute Standard Deviation 34.26	61.91 liter/minute Standard Deviation 43.39
Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16 NPIF-Evening	26.65 liter/minute Standard Deviation 34.31	61.25 liter/minute Standard Deviation 45.91

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants from ITT population with data available for UPSIT at Week 16.

UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=28 Participants 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.
Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16	-0.17 score on scale Standard Deviation 5.1	15.36 score on scale Standard Deviation 9.61

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants from ITT population with CT scan data available at Week 16.

CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=29 Participants 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.
Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score	-0.23 score on scale Standard Deviation 3.74	-9.24 score on scale Standard Deviation 4.58

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants from ITT population with CT scan data available at Week 16.

CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=29 Participants 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.
Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease	-3.92 percent area Standard Deviation 20.54	-35.66 percent area Standard Deviation 24.28

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITT population.

The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as \>=1 point reduction from baseline score); for participants without NPS \>=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=30 Participants 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.
Time to First Response in NPS: Kaplan-Meier Estimate at Week 16	0.44 Probability of response Interval 0.242 to 0.638	0.828 Probability of response Interval 0.69 to 0.965

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants from ITT population with SNOT-22 data available at Week 16.

The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=29 Participants 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.
Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16	-8.26 score on a scale Standard Deviation 17.63	-29.1 score on a scale Standard Deviation 19.9

POST_HOC outcome

Timeframe: Baseline, Week 16

Population: Participants from ITT population with nTSS data available at Week 16.

nTSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale. Total score ranges from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated severe symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.	Dupilumab 300 mg QW n=29 Participants 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.
Change From Baseline in Nasal Total Symptoms Score (nTSS) at Week 16 nTSS - Morning	-0.68 score on a scale Standard Deviation 1.44	-2.87 score on a scale Standard Deviation 2.09
Change From Baseline in Nasal Total Symptoms Score (nTSS) at Week 16 nTSS - Evening	-0.77 score on a scale Standard Deviation 1.48	-2.9 score on a scale Standard Deviation 2.04

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Dupilumab 300 mg QW

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=30 participants at risk Participants exposed to placebo (for dupilumab) added to MFNS (mean exposure of 14 weeks).	Dupilumab 300 mg QW n=30 participants at risk Participants exposed to dupilumab added to MFNS (mean exposure of 16 weeks).
Infections and infestations Herpes zoster	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
Nervous system disorders Hypoaesthesia	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
Nervous system disorders Mononeuropathy	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
Nervous system disorders Transient ischaemic attack	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
Cardiac disorders Arrhythmia	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
Respiratory, thoracic and mediastinal disorders Asthma	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
Respiratory, thoracic and mediastinal disorders Nasal polyps	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and deaths are treatment emergent AEs that developed/worsened and deaths that occurred during the 'treatment emergent period' (from the first dose of the double-blind IMP injection up to the end of the 16 weeks post-treatment period).

Other adverse events

Additional Information

Trial Transparency Team

Sanofi

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER