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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03992417
Other study ID # OBS15990
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 11, 2019
Est. completion date March 31, 2027

Study information

Verified date March 2024
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Primary Objective: To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD Secondary Objectives: - To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching) - To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting - To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD - To collect safety data on study participants


Description:

Participants enrolled in the study will be followed for 5 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 955
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group; - Initiating treatment with Dupixent® for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent® for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index [EASI], Scoring of Atopic Dermatitis [SCORAD], body surface area [of AD involvement] [BSA], Patient-Oriented Eczema Measure [POEM], and Dermatology Life Quality Index [DLQI]) by the registry protocol were captured at the time of initiating Dupixent® treatment and are available for entry in the registry database - Able to understand and complete study-related questionnaires - Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable Exclusion Criteria: - Participants who have a contraindication to the drug according to the country-specific prescribing information label - Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the participant patient from adequately completing the schedule of visits and assessments - Patients currently participating in any interventional clinical trial which modifies patient care - Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dupilumab SAR231893 (REGN668)
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Locations

Country Name City State
Argentina Investigational Site Number : 0320011 Ciudad Autonoma Bs As
Argentina Investigational Site Number : 0320013 Pilar Buenos Aires
Argentina Investigational Site Number : 0320012 Rosario Santa Fe
Australia Investigational Site Number : 0360004 Bedford Park South Australia
Australia Investigational Site Number : 0360001 Carlton Victoria
Australia Investigational Site Number : 0360002 Kogarah New South Wales
Australia Investigational Site Number : 0360005 Kogarah New South Wales
Australia Investigational Site Number : 0360003 Woolloongabba Queensland
Austria Investigational Site Number : 0400005 Graz
Austria Investigational Site Number : 0400004 Linz
Austria Investigational Site Number : 0400002 Maria Enzersdorf
Austria Investigational Site Number : 0400001 Vienna
Belgium Investigational Site Number : 0560002 Brussels
Belgium Investigational Site Number : 0560007 Edegem
Belgium Investigational Site Number : 0560010 Gent
Belgium Investigational Site Number : 0560003 Jette
Belgium Investigational Site Number : 0560001 Leige
Belgium Investigational Site Number : 0560008 Leuven
Belgium Investigational Site Number : 0560004 Namur
Belgium Investigational Site Number : 0560006 Roeselare
Colombia Investigational Site Number : 1700008 Bogota
Colombia Investigational Site Number : 1700012 Bogota
Colombia Investigational Site Number : 1700011 Medellín
Czechia Investigational Site Number : 2030008 Hradec Kralove
Czechia Investigational Site Number : 2030006 Olomouc
Czechia Investigational Site Number : 2030003 Ostrava - Poruba
Czechia Investigational Site Number : 2030004 Plzen
Czechia Investigational Site Number : 2030005 Praha 1
Czechia Investigational Site Number : 2030002 Praha 5
Czechia Investigational Site Number : 2030001 Usti nad Labem
Finland Investigational Site Number : 2460002 Kokkola
France Investigational Site Number : 2500011 Antony
France Investigational Site Number : 2500004 Auxerre
France Investigational Site Number : 2500003 Bordeaux
France Investigational Site Number : 2500009 Montpellier Cedex 5
France Investigational Site Number : 2500006 Pierre Benite cedex
France Investigational Site Number : 2500010 Rouen
France Investigational Site Number : 2500005 Saint-Mandé Cedex
France Investigational Site Number : 2500002 Toulouse Cedex 9
France Investigational Site Number : 2500001 Valence
Greece Investigational Site Number : 3000002 Athens
Greece Investigational Site Number : 3000001 Thessaloniki
Greece Investigational Site Number : 3000003 Thessaloniki
Israel Investigational Site Number : 3760006 Afula
Israel Investigational Site Number : 3760001 Haifa
Israel Investigational Site Number : 3760005 Haifa
Israel Investigational Site Number : 3760002 Jerusalem
Israel Investigational Site Number : 3760004 Ramat Gan
Israel Investigational Site Number : 3760003 Rehovot
Italy Investigational Site Number : 3800012 Bari
Italy Investigational Site Number : 3800007 Brescia
Italy Investigational Site Number : 3800013 Cagliari
Italy Investigational Site Number : 3800008 Genova
Italy Investigational Site Number : 3800015 L'Aquila
Italy Investigational Site Number : 3800004 Milano
Italy Investigational Site Number : 3800001 Napoli
Italy Investigational Site Number : 3800018 Palermo
Italy Investigational Site Number : 3800010 Pisa
Italy Investigational Site Number : 3800005 Roma
Italy Investigational Site Number : 3800003 Rome Roma
Italy Investigational Site Number : 3800011 Rome Roma
Italy Investigational Site Number : 3800017 Terracina Latina
Italy Investigational Site Number : 3800016 Torino
Italy Investigational Site Number : 3800009 Torrette Di Ancona Ancona
Japan Investigational Site Number : 3920022 Amagasaki-shi
Japan Investigational Site Number : 3920002 Habikino-shi
Japan Investigational Site Number : 3920014 Hamamatsu-shi
Japan Investigational Site Number : 3920011 Hirakata-shi Osaka
Japan Investigational Site Number : 3920003 Itabashi-ku Tokyo
Japan Investigational Site Number : 3920008 Koshigaya-shi Saitama
Japan Investigational Site Number : 3920025 Kyoto-shi
Japan Investigational Site Number : 3920013 Marugame-shi
Japan Investigational Site Number : 3920012 Minokamo-shi
Japan Investigational Site Number : 3920004 Nagakute-shi Aichi
Japan Investigational Site Number : 3920001 Nagoya-shi
Japan Investigational Site Number : 3920015 Obihiro-shi Hokkaido
Japan Investigational Site Number : 3920006 Sapporo-shi Hokkaido
Japan Investigational Site Number : 3920010 Setagaya-ku
Japan Investigational Site Number : 3920005 Shimotsuga-gun Tochigi
Japan Investigational Site Number : 3920020 Yokohama-shi
Kuwait Investigational Site Number : 4140001 Sulaibikat
Mexico Investigational Site Number : 4840001 Guadalajara Jalisco
Netherlands Investigational Site Number : 5280002 Bergen op Zoom
Norway Investigational Site Number : 5780002 Bergen
Norway Investigational Site Number : 5780001 Bodø
Portugal Investigational Site Number : 6200003 Coimbra
Portugal Investigational Site Number : 6200002 Lisboa
Portugal Investigational Site Number : 6200004 Porto
Portugal Investigational Site Number : 6200001 Vila Nova de Gaia
Russian Federation Investigational Site Number : 6430001 Moscow
Russian Federation Investigational Site Number : 6430002 Moscow
Russian Federation Investigational Site Number : 6430004 Saint-Petersburg
Saudi Arabia Investigational Site Number : 6820013 Dammam
Saudi Arabia Investigational Site Number : 6820001 Jeddah
Spain Investigational Site Number : 7240017 Baracaldo
Spain Investigational Site Number : 7240009 Barcelona
Spain Investigational Site Number : 7240014 Barcelona
Spain Investigational Site Number : 7240019 Bilbao Bizkaia
Spain Investigational Site Number : 7240021 Granada
Spain Investigational Site Number : 7240004 Las Palmas de Gran Canaria Las Palmas
Spain Investigational Site Number : 7240001 Madrid
Spain Investigational Site Number : 7240006 Madrid
Spain Investigational Site Number : 7240007 Madrid
Spain Investigational Site Number : 7240010 Madrid
Spain Investigational Site Number : 7240016 Madrid
Spain Investigational Site Number : 7240012 Majadahonda Madrid
Spain Investigational Site Number : 7240002 Oviedo Asturias
Spain Investigational Site Number : 7240008 Santiago de Compostela
Spain Investigational Site Number : 7240011 Santullano De Mieres Asturias
Taiwan Investigational Site Number : 1580012 Kaohsiung
Taiwan Investigational Site Number : 1580011 Taichung
Taiwan Investigational Site Number : 1580014 Taipei
Taiwan Investigational Site Number : 1580015 Taoyuan County
United Arab Emirates Investigational Site Number : 7840002 Al Ain

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Colombia,  Czechia,  Finland,  France,  Greece,  Israel,  Italy,  Japan,  Kuwait,  Mexico,  Netherlands,  Norway,  Portugal,  Russian Federation,  Saudi Arabia,  Spain,  Taiwan,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline Characteristics: Medical history Baseline to Month 60
Primary Baseline Characteristics: Socio-demographics Baseline to Month 60
Primary Baseline Characteristics: Disease characteristics Baseline to Month 60
Secondary Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis Percentage of BSA affected by AD assessed for each major section of the body Baseline to Month 60
Secondary Physician Assessment: Eczema Area and Severity Index (EASI) Measure used in clinical practice and clinical trials to assess the severity and extent of AD Baseline to Month 60
Secondary Physician Assessment: Scoring of Atopic Dermatitis (SCORAD) Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD Baseline to Month 60
Secondary Participant Assessment: Patient Oriented Eczema Measure (POEM) Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults Baseline to Month 60
Secondary Participant Assessment: Pruritus Numerical Rating Scale (NRS) Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale Baseline to Month 60
Secondary Participant Assessment: Skin Pain or Soreness NRS Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS Baseline to Month 60
Secondary Participant Assessment: Skin Feeling Hot NRS Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS Baseline to Month 60
Secondary Participant Assessment: Skin Sensitivity NRS Individual NRS used to rate skin sensitivity using a 0 to 10 NRS Baseline to Month 60
Secondary Participant Assessment: Sleep Disturbance NRS Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS Baseline to Month 60
Secondary Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) Baseline to Month 60
Secondary Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5) Questionnaire to evaluate asthma control in participants with comorbid asthma Baseline to Month 60
Secondary Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS) Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis Baseline to Month 60
Secondary Participant Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) for adults and Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) for adolescents Questionnaire to assess the impact of AD on productivity Baseline to Month 60
Secondary Participant Assessment: Health Care Resource Utilization Questionnaire Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD Baseline to Month 60
Secondary Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9) Instrument to measure treatment satisfaction Baseline to Month 60
Secondary Adverse events (AEs) Number of participants with at least 1 AE Baseline to Month 60
Secondary Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally Questionnaire related with Atopic dermatitis control Baseline to Month 60
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