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SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Dupilumab

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Participants, male or female 18 years or older,

with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance.
had applied skin emollients (moisturizers) at least 7 days before screening.
had applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before screening.
willed and able to comply with all clinic visits and study-related procedures.
provided signed informed consent.

Exclusion criteria:

Participants excluded from the study:

with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that might present unreasonable risk to participants or interfered with study assessment, or any severe concomitant illness(es) that would adversely affect the participant's participation in the study, and contraindications of topical corticosteroids.
at Baseline, presence of any conditions listed as criteria for study drug discontinuation.

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dupilumab/Dupilumab

Placebo/Dupilumab

Arm Description

Participants received dupilumab 600 milligrams (mg) (loading dose) injection subcutaneously (SC) on Day 1 followed by dupilumab 300 mg injection SC every 2 weeks (q2w) up to Week 10 in the double-blind (DB) period of 12 weeks. After completion of DB period, participants entered in the open-label extension (OLE) period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.

Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.

Outcomes

Primary Outcome Measures

DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12

Sleep quality NRS was used to assess the quality of the participant's previous night's sleep. It was collected on a 11-point scale ranged from 0 (worst possible sleep) to 10 (best possible sleep), where higher score indicated better outcome. Percent change from Baseline in sleep quality NRS at Week 12 was reported in this outcome measure.

Secondary Outcome Measures

DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12

Peak Pruritus NRS was an assessment tool that was used by participants to report the intensity of their pruritus (itch) during a 24-hour recall period. Participants were asked the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Participants answered the question at the specified time point (for the last 24 hours) on the scale of 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity.

DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12

SCORAD is a validated scoring index for AD, which consists of 3 components i.e., A =extent or affected body surface area (BSA) assessed as a percentage of each defined body area and reported as the sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using the following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on VAS, where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), and subjective symptoms (C: 0-20) using the formula: A/5 + 7*B/2+ C to give the SCORAD total score range of 0 to 103, where 0 = no disease to 103 = severe disease. Higher values of SCORAD represent worse outcome.

DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12

SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on itch and sleeplessness, each scored (0-10). The SCORAD for an individual was calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (i.e., itch and sleeplessness/sleep loss) were each scored by the participant using a VAS ranging from 0 to 10, where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleeplessness). Change from Baseline in SCORAD sleeplessness/sleep loss VAS score is reported in this outcome measure.

DB Period: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a (SF8a) Total T-Score at Week 12

PROMIS is a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Level 2, sleep disturbance measure. In this study, 8- item PROMIS Sleep Related Impairment SF8a that assesses the domain of sleep related impairment in the past 7 days in individuals aged 18 and older, was used. Each item asks the participant to rate the severity of the participant's sleep related impairment during the past 7 days (at each specified visit) on a 5-point scale (1 = not at all; 2 = a little bit; 3 = somewhat; 4 = quite a bit; and 5 = very much) with raw score ranging from 8 to 40; higher scores indicating greater severity of sleep impairment. PROMIS T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Possible range for T-score is 30 to 80, with higher scores indicating greater severity of sleep impairment.

DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12

A sleep diary was designed to gather information about participant's daily sleep pattern. It measured night-time sleep assessments. TST (in minutes) was calculated using the formula: Time of waking up for the day minus time of falling sleep minus Wake After Sleep Onset (WASO), where WASO = time awake after initial sleep onset but before the final awakening for the day. Data for WASO was collected from Question 3 of the Sleep Diary: "Considering all the times you woke up last night, how much time were you awake in total?". Baseline and Post-baseline weekly average data were calculated based on the mean of the data over the 7 days prior to and including the day at the Baseline or at the end of the corresponding week. In this outcome measure, change from Baseline in TST at Week 12 is reported.

DB Period: Change From Baseline in Weekly Average Sleep Efficiency (SE) at Week 12

A sleep diary was designed to gather information about participant's daily sleep pattern. It measured night-time sleep assessments. SE was calculated using the formula: (TST divided by [Time of waking up for the day - Time of trying to fall sleep]) multiplied by 100 percent (%). TST (in minutes) was calculated using the formula: Time of waking up for the day minus time of falling sleep minus Wake After Sleep Onset (WASO), where WASO = time awake after initial sleep onset but before the final awakening for the day. Baseline and Post-baseline weekly average data were calculated based on the mean of the data over the 7 days prior to and including the day at the Baseline or at the end of the corresponding week. In this outcome measure, change from Baseline in SE at Week 12 is reported.

DB Period: Change From Baseline in Weekly Average Wake After Sleep Onset (WASO) at Week 12

A sleep diary was designed to gather information about participant's daily sleep pattern. It measured night-time sleep assessments. WASO = time awake (in minutes) after initial sleep onset but before the final awakening for the day. Data for WASO was collected from Question 3 of the Sleep Diary: "Considering all the times you woke up last night, how much time were you awake in total?". Baseline and Post-baseline weekly average data were calculated based on the mean of the data over the 7 days prior to and including the day at the Baseline or at the end of the corresponding week. In this outcome measure, change from Baseline in WASO at Week 12 is reported.

DB Period: Change From Baseline in Weekly Average Sleep Onset Latency (SOL) at Week 12

A sleep diary was designed to gather information about participant's daily sleep pattern. It measured night-time sleep assessments. SOL (in minutes) was calculated using the formula: Time of falling sleep - Time of trying to fall sleep. Baseline and Post-baseline weekly average data were calculated based on the mean of the data over the 7 days prior to and including the day at the Baseline or at the end of the corresponding week. In this outcome measure, change from Baseline in SOL at Week 12 is reported.

DB Period: Percentage of Participants With Eczema Area Severity Index-50 (EASI-50) (Greater Than or Equal to [>=] 50% Improvement From Baseline) at Week 12

EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each body region: 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), and 6 (90% to 100%). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Percentage of participants with EASI-50 (>=50% improvement from Baseline in EASI score) at Week 12 is reported in this outcome measure.

DB Period: Percentage of Participants With Eczema Area Severity Index-75 (EASI-75) (>= 75% Improvement From Baseline) at Week 12

EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each body region: 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), and 6 (90% to 100%). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Percentage of participants with EASI-75 (>=75% improvement from Baseline in EASI score) at Week 12 is reported in this outcome measure.

DB Period: Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 12

The POEM was a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with AD. The format is participant response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (i.e., 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.

DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12

DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranged from 0 to 3 where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as 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. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (from the first investigational medicinal product [IMP] administration to the last IMP administration + 14 days) in DB period.

Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. SAEs were defined as 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. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (from the first IMP administration to the last IMP administration + 14 days).

Full Information

NCT ID

NCT04033367

First Posted

July 16, 2019

Last Updated

October 5, 2022

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04033367

Brief Title

SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

Official Title

A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

August 22, 2019 (Actual)

Primary Completion Date

October 6, 2021 (Actual)

Study Completion Date

October 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD). Secondary Objectives: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation. To continue to assess the safety and tolerability throughout the study.

Detailed Description

Duration per participant was up to 28 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dupilumab/Dupilumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo/Dupilumab

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

SAR231893

Intervention Description

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a (SF8a) Total T-Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in Weekly Average Sleep Efficiency (SE) at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in Weekly Average Wake After Sleep Onset (WASO) at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in Weekly Average Sleep Onset Latency (SOL) at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Percentage of Participants With Eczema Area Severity Index-50 (EASI-50) (Greater Than or Equal to [>=] 50% Improvement From Baseline) at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Percentage of Participants With Eczema Area Severity Index-75 (EASI-75) (>= 75% Improvement From Baseline) at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Description

Time Frame

Baseline up to 14 days after last IMP administration (i.e., up to Week 12)

Title

Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Description

Time Frame

Baseline up to 14 days after last IMP administration (i.e., up to Week 24)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Participants, male or female 18 years or older, with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications, 2) expected severity of AD and 3) sleep disturbance. had applied skin emollients (moisturizers) at least 7 days before screening. had applied medium potency topical corticosteroids (TCS) on all active AD lesions at least 7 days before screening. willed and able to comply with all clinic visits and study-related procedures. provided signed informed consent. Exclusion criteria: Participants excluded from the study: with known hypersensitivity to Dupixent, clinical depression, drug abuse history, sleep problems not related to AD, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that might present unreasonable risk to participants or interfered with study assessment, or any severe concomitant illness(es) that would adversely affect the participant's participation in the study, and contraindications of topical corticosteroids. at Baseline, presence of any conditions listed as criteria for study drug discontinuation. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number :8400012

City

North Little Rock

State/Province

Arkansas

ZIP/Postal Code

72117

Country

United States

Facility Name

Investigational Site Number :8400002

City

Redwood City

State/Province

California

ZIP/Postal Code

94063

Country

United States

Facility Name

Investigational Site Number :8400001

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Investigational Site Number :8400013

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Investigational Site Number :8400005

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Investigational Site Number :8400003

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Investigational Site Number :8400007

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Investigational Site Number :8400008

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Investigational Site Number :0360006

City

Phillip

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

Investigational Site Number :0360001

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Investigational Site Number :0360007

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Investigational Site Number :0360003

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Investigational Site Number :2500001

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Investigational Site Number :2500003

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number :2500002

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Investigational Site Number :2500006

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Investigational Site Number :2760005

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Investigational Site Number :2760002

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Investigational Site Number :2760006

City

Friedrichshafen

ZIP/Postal Code

88045

Country

Germany

Facility Name

Investigational Site Number :2760001

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Investigational Site Number :2760004

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Investigational Site Number :3760005

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Investigational Site Number :3760003

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Investigational Site Number :3800005

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Investigational Site Number :3800006

City

Perugia

ZIP/Postal Code

06129

Country

Italy

Facility Name

Investigational Site Number :3800001

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Investigational Site Number :3800004

City

Reggio Calabria

ZIP/Postal Code

86100

Country

Italy

Facility Name

Investigational Site Number :3800002

City

Roma

ZIP/Postal Code

168

Country

Italy

Facility Name

Investigational Site Number :3800003

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Investigational Site Number :7240004

City

Granada

State/Province

Andalucia

ZIP/Postal Code

18016

Country

Spain

Facility Name

Investigational Site Number :7240001

City

Barcelona / Sabadell

State/Province

Castilla Y León

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number :7240003

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

Country

Spain

Facility Name

Investigational Site Number :7240006

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Investigational Site Number :7240008

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Investigational Site Number :7240010

City

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Investigational Site Number :7240005

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Investigational Site Number :7240002

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Investigational Site Number :7560001

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Investigational Site Number :7840002

City

Abu Dhabi

ZIP/Postal Code

46713

Country

United Arab Emirates

Facility Name

Investigational Site Number :7840001

City

Dubai

Country

United Arab Emirates

Facility Name

Investigational Site Number :8260002

City

Dudley

State/Province

Birmingham

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Investigational Site Number :8260004

City

Edinburgh

State/Province

Edinburgh, City Of

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

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SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial