Atopic DermatitisPROTYPE2NCT06039241
Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Sanofi at 55 sites in Germany.
Trial summary
This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 572 participants
- Where
- 55 sitesGermany
- Study dates
- 7 Mar 2023to 8 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their severe AD (6-11 years) or moderate to severe AD (adult and adolescent patients ≥12 years of age) according to the Summary of Product Characteristics. The decision to initiate treatment with dupilumab will be made by the attending physician based on the patient's medical requirements and standards of best medical practice. This decision will be made independent of and prior to data collection in this non-interventional study (NIS).
Who may be able to join
- Patients are at least 6 years of age at the baseline visit.
- Initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe AD, or in children 6 to 11 years of age with severe AD according to the Summary of Product Characteristics.
- Patients or their guardians are able to understand and complete the study-related questionnaires.
- Signing a written informed consent form by the patients before the initiation of documentation within the framework of this NIS or informed consent of parents/guardian, if applicable.
Who cannot join
- Patients who have a contraindication for dupilumab based on the current Summary of Product Characteristics.
- Patients who have already been treated with dupilumab for more than 7 days.
- Any acute or chronic diseases, which, in the opinion of the attending physician, would impair the patient's ability to complete questionnaires or participate in this study or could affect the interpretation of the results.
- Participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
Germany55 sites
Investigational Site Number: 061
Aachen, 52064
Investigational Site Number: 092
Ahaus, 48683
Investigational Site Number: 066
Andernach, 56626
Investigational Site Number: 002
Berlin, 10117
Investigational Site Number: 003
Berlin, 10627
Investigational Site Number: 176
Berlin, 10997
Investigational Site Number: 077
Berlin, 12353
Investigational Site Number: 004
Berlin, 13086
Investigational Site Number: 174
Berlin, 13403
Investigational Site Number: 073
Berlin, 13507
Investigational Site Number: 059
Braunschweig, 38114
Investigational Site Number: 057
Buxtehude, 21614
Investigational Site Number: 028
Chemnitz, 09113
Investigational Site Number: 069
Cologne, 50733
Investigational Site Number: 072
Dresden, 01109
Investigational Site Number: 026
Dresden, 01277
Investigational Site Number: 032
Düren, 52349
Investigational Site Number: 043
Erlangen, 91054
Investigational Site Number: 064
Essen, 45149
Investigational Site Number: 184
Friedberg, 61169
Investigational Site Number: 055
Gera, 07545
Investigational Site Number: 007
Giessen, 35392
Investigational Site Number: 031
Gladbeck, 45964
Investigational Site Number: 078
Göttingen, 37075
Investigational Site Number: 087
Hamburg, 20249
Investigational Site Number: 088
Hamburg, 22159
Investigational Site Number: 020
Hamburg, 22303
Investigational Site Number: 086
Hamburg, 22549
Investigational Site Number: 169
Heidelberg, 69115
Investigational Site Number: 053
Heilbad Heiligenstadt, 37308
Investigational Site Number: 063
Jülich, 52428
Investigational Site Number: 186
Karlsruhe, 76133
Investigational Site Number: 016
Kiel, 24103
Investigational Site Number: 017
Kiel, 24105
Investigational Site Number: 183
Landsberg, 06188
Investigational Site Number: 038
Langenau, 89129
Investigational Site Number: 179
Leipzig, 04315
Investigational Site Number: 178
Mainz, 55116
Investigational Site Number: 185
Mainz, 55116
Investigational Site Number: 014
Mainz, 55128
Investigational Site Number: 013
Mannheim, 68167
Investigational Site Number: 018
Mölln, 23879
Investigational Site Number: 035
Mönchengladbach, 41061
Investigational Site Number: 050
München, 80331
Investigational Site Number: 076
Neubrandenburg, 17036
Investigational Site Number: 045
Nuremberg, 90402
Investigational Site Number: 042
Nuremberg, 90419
Investigational Site Number: 024
Oelde, 59302
Investigational Site Number: 082
Potsdam, 14469
Investigational Site Number: 172
Remscheid, 42897
Investigational Site Number: 177
Rostock, 18055
Investigational Site Number: 047
Wasserburg, 83512
Investigational Site Number: 019
Wismar, 23966
Investigational Site Number: 168
Wittlich, 54516
Investigational Site Number: 193
Wuppertal, 42349
About this study
Official title: Prospective, Non-interventional, Observational Study for Multi-dimensional Assessment of Signs, Symptoms, Quality of Life and Disease Control of Long-term Treatment With Dupilumab in Patients With Atopic Dermatitis (≥6 Years)
This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AD patients treated with dupilumab | Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their severe AD (6-11 years) or moderate to severe AD (adult and adolescent patients ≥12 years of age) based on the patient's medical requirements and standards of best medical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who maintain Eczema Area and Severity Index (EASI) ≤ 7 OR peak pruritus Numerical Rating Scale (NRS) ≤ 4 OR Dermatology Life Quality Index (DLQI) ≤ 5
EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. DLQI is a questionaire with a score system of 0 to 30 the high score is indicative of poor QoL
Measured: From Month 6 to Month 12
Mean percent change from baseline in Atopic Dermatitis Control Tools (ADCT) score (≥12 years)
Atopic dermatitis control tool (ADCT) is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision- making. ADCT questionnaire assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control. ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.
Measured: From baseline to Week 52
Mean percent change from baseline in Recap of atopic eczema (RECAP) score (6-11 years)
Recap of atopic eczema (RECAP) is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. Patient's who turn 12 years during the course of study will continue to complete RECAP.
Measured: From baseline to Week 52
Secondary outcomes (46)
Incidence of treatment emergent adverse events (TEAEs) during the observation period
Treatment emergent AEs and SAEs reported
Measured: From baseline up to 24 months
Incidence of dupilumab-related TEAEs during the observation period.
Treatment emergent AEs and SAEs reported
Measured: From baseline up to 24 months
Event rate (per patient year) by type of TEAEs during the observation period.
Measured: From baseline up to 24 months
Event rate (per patient year) by type of dupilumab related TEAEs during the observational period
Measured: From Baseline up to 24 months
Treating physician reported effectiveness data: Change from baseline in IGA score after 6, 12, and 24 months dupilumab therapy
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity
Measured: From baseline up to 24 months
Treating physician reported effectiveness data.: Number of patients achieving EASI-75 (improvement in EASI score from baseline of ≥ 75%) after 6, 12 and 24 months of dupilumab therapy
EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders are the participants who achieved ≥75% improvement from baseline.
Measured: From baseline up to 24 months
Treating physician reported effectiveness data: Absolute change from baseline in EASI score after 6, 12 and 24 months of dupilumab therapy
EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of AD, The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
Measured: From baseline up to 24 months
Treating physician reported effectiveness data: Percentage change from baseline in EASI score after 6, 12, and 24 months of dupilumab therapy
EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Measured: From baseline up to 24 months
Treating physician reported effectiveness data: Absolute change from baseline in IGA score after 6, 12, and 24 months of dupilumab therapy
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Measured: From baseline up to 24 months
Treating physician reported effectiveness data: Change from baseline in body surface area (BSA) after 6, 12, and 24 months of dupilumab therapy
Affected body surface area is measured.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on quality of life (QoL) data: Mean absolute change from baseline in Atopic Dermatitis Control Test (ADCT) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy
ADCT is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision making. The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in ADCT score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy
ADCT is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision-making. The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Recap of atopic eczema (RECAP) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy
Recap of atopic eczema (RECAP) is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. The RECAP can range from 0 to 28, where a lower score indicates a better outcome.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in RECAP score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy
RECAP is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. The RECAP can range from 0 to 28, where a lower score indicates a better outcome.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM) score after 6, 12, and 24 months of dupilumab therapy
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28, the higher score indicating higher severity.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in POEM score after 6, 12, and 24 months of dupilumab therapy
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28, the higher score indicating higher severity.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Dermatology Life Quality Index/Children's Dermatology Life Quality Index (DLQI/CDLQI) score after 6, 12, and 24 months of dupilumab therapy.
The Dermatology Quality of Life Index (DLQI) is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patient's ≥ 16 years of age) and the CDLQI for patients \< 16 years of age. Each question is scored on a four-point Likert scale.The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (CDLQI) score after 6, 12, and 24 months of dupilumab therapy
The Dermatology Quality of Life Index (DLQI) is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patient's ≥ 16 years of age) and the CDLQI for patients \< 16 years of age. Each question is scored on a four-point Likert scale.The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean Absolute Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance score after 6, 12, and 24 months of dupilumab therapy.
Patient-Reported Outcomes Measurement Information System® (PROMIS®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS® Sleep Disturbance Scale was developed to assess self-reported perceptions of sleep quality, sleep depth, and any perceived difficulties related to getting and staying asleep over a 7-day period. Response options for the sleep quality item range from: "Very poor (1)" to "Very good (5)" or from "Not at all (1)" to "Very much (5).
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean Percent Change from baseline in PROMIS sleep disturbance score after 6, 12, and 24 months of dupilumab therapy
Patient-Reported Outcomes Measurement Information System® (PROMIS®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS® Sleep Disturbance Scale was developed to assess self-reported perceptions of sleep quality, sleep depth, and any perceived difficulties related to getting and staying asleep over a 7-day period. Response options for the sleep quality item range from: "Very poor (1)" to "Very good (5)" or from "Not at all (1)" to "Very much (5).
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in At baseline Questionnaire on Experience with Skin complaints (QES) score after 6, 12, and 24 months of dupilumab therapy
The Questionnaire on Experience with Skin Complaints (QES) [8] is a fully standardized self-rating instrument that focuses on the feelings of stigmatization of patients with different skin diseases and the coping with the stigma experience.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in At baseline Questionnaire on Experience with Skin complaints (QES) score after 6, 12, and 24 months of dupilumab therapy
The Questionnaire on Experience with Skin Complaints (QES) [8] is a fully standardized self-rating instrument that focuses on the feelings of stigmatization of patients with different skin diseases and the coping with the stigma experience.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Patient Global Assessment (PtGA) score after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
The Global Patient Assessment is a 2-component questionnaire on symptom severity and the patient's overall satisfaction with their treatment.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in Patient Global Assessment (PtGA) score after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
The Global Patient Assessment is a 2-component questionnaire on symptom severity and the patient's overall satisfaction with their treatment
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: : Mean percent change from baseline in Asthma control questionnaire-5 (ACQ-5)-Scores, assessed only in patients with co-existing Asthma after 3, 6, 9,12, 15, 18, and 24 months of dupilumab therapy
The ACQ-5 assesses asthma control using the 5-item ACQ-5 questionnaire.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Asthma control questionnaire-5 (ACQ-5)-Scores, assessed only in patients with co-existing Asthma) after 3, 6, 9,12, 15, 18, and 24 months of dupilumab therapy
The ACQ-5 assesses asthma control using the 5-item ACQ-5 questionnaire.
Measured: From baseline up to 24 months
Mean absolute change from baseline in Allergic Visual analogue Scales ([Allergic-VAS] only patients with co-existing overall allergic symptoms) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Patient reported effectiveness and impact on QoL data: will be assessed. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.
Measured: From baseline up to 24 months
Mean percent change from baseline in Allergic Visual Analogue Scales ([Allergic-VAS] only patients with co-existing overall allergic symptoms) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Patient reported effectiveness and impact on QoL data: will be assessed. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.
Measured: From Baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in MACVIA-ARIA Sentinel Network Rhinitis Visual Analog Score (MASK-Rhinitis VAS score).
Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in MACVIA-ARIA Sentinel Network Rhinitis Visual Analog Score (MASK-Rhinitis VAS score)
Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in MACVIA-ARIA Sentinel Network conjunctivitis Visual Analog Score (MASK-conjunctivitis VAS score), after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy.
Only assessed in patients with co-existing allergic conjunctivitis. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.
Measured: From baseline up to 24 months
Mean percent change from baseline in MACVIA-ARIA Sentinel Network conjunctivitis Visual Analog Score (MASK-conjunctivitis VAS score) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Only assessed in patients with co-existing allergic conjunctivitis. Patient reported effectiveness and impact on QoL data: will be aVisual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. VAS is usually a horizontal 100 mm long scale with two opposing descriptors at its end points. The lower numbers indicate less severity, and the higher numbers indicate greater severity.
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Sinus Control Test (SCT) score, only assessed in patients with co-existing chronic rhinosinusitis after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
The SCT involves four questions, three of which are answered using a 5-point Likert scale and one dichotomous question. The SCT total score is used to categorize patient control status into three groups: controlled (total score 0-3), partially controlled (total score 4-11), and uncontrolled (total score 12-16).
Measured: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in SCT score, only assessed in patients with co-existing chronic rhinosinusitis after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
The SCT involves four questions, three of which are answered using a 5-point Likert scale and one dichotomous question. The SCT total score is used to categorize patient control status into three groups: controlled (total score 0-3), partially controlled (total score 4-11), and uncontrolled (total score 12-16).
Measured: From baseline up to 24 months
Patient and treatment characteristics reported by the physician or patient: Socio -demographic data
Measured: At baseline
Patient and treatment characteristics reported by the physician or patient: Medical history of disease
Measured: At baseline
Patient and treatment characteristics reported by the physician or patient: Comorbidities/smoker status/alcohol usage
Measured: At baseline
Patient and treatment characteristics reported by the physician or patient: Prior systemic AD treatment (including balneophototherapy and/or UV therapy)
Measured: At baseline
Patient and treatment characteristics reported by the physician or patient: Current topical and/or systemic AD treatment of the last 4 weeks before baseline visit (dosage, type)
Measured: At baseline
Patient and treatment characteristics reported by the physician or patient: Current treatment for co-existing type 2 inflammatory and atopic diseases
Data reported for dosage and type of current treatment for co-existing type 2 inflammatory and atopic diseases.
Measured: At baseline
Patient and treatment characteristics reported by the physician or patient: Reasons for initiating dupilumab treatment
Measured: At baseline
Patient and treatment characteristics reported by the physician or patient: Reasons for discontinuation of dupilumab treatment (if the discontinuation was before end of study)
Reasons for discontinuation of dupilumab treatment (if the discontinuation was before end of study) will be collected at the discontinuation visit.
Measured: Up to 24 months
Patient and treatment characteristics reported by the physician or patient: Number of sick-leave days away from work/school due to AD
Measured: From baseline up to 24 months
Patient and treatment characteristics reported by the physician or patient: Number of medical appointments due to AD
Measured: From baseline up to 24 months
Patient and treatment characteristics reported by the physician or patient: Number of visits to alternative practitioners and complementary care physicians
Measured: From baseline upto 24 months
Patient and treatment characteristics reported by the physician or patient: Cost of non-reimbursable supplementary therapy [€/month]
Measured: From baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start7 Mar 2023
- Primary completion8 Mar 2028 (estimated)
- Study completion8 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039241
- Sponsor's protocol ID
- OBS17251
- Other IDs
- U1111-1293-5998
- Acronym
- PROTYPE2
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional, Observational Study for Multi-dimensional Assessment of Signs, Symptoms, Quality of Life and Disease Control of Long-term Treatment With Dupilumab in Patients With Atopic Dermatitis (≥6 Years)
- ClinicalTrials.gov ID
- NCT06039241
- Acronym / sponsor ID
- PROTYPE2 / OBS17251
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 572 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 8 Mar 2028 (estimated)
- Study completion
- 8 Mar 2028 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD patients treated with dupilumab | – | –Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their severe AD (6-11 years) or moderate to severe AD (adult and adolescent patients ≥12 years of age) based on the patient's medical requirements and standards of best medical practice. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their severe AD (6-11 years) or moderate to severe AD (adult and adolescent patients ≥12 years of age) according to the Summary of Product Characteristics. The decision to initiate treatment with dupilumab will be made by the attending physician based on the patient's medical requirements and standards of best medical practice. This decision will be made independent of and prior to data collection in this non-interventional study (NIS).
Key inclusion criteria (4 listed)
- Patients are at least 6 years of age at the baseline visit.
- Initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe AD, or in children 6 to 11 years of age with severe AD according to the Summary of Product Characteristics.
- Patients or their guardians are able to understand and complete the study-related questionnaires.
- Signing a written informed consent form by the patients before the initiation of documentation within the framework of this NIS or informed consent of parents/guardian, if applicable.
Key exclusion criteria (5 listed)
- Patients who have a contraindication for dupilumab based on the current Summary of Product Characteristics.
- Patients who have already been treated with dupilumab for more than 7 days.
- Any acute or chronic diseases, which, in the opinion of the attending physician, would impair the patient's ability to complete questionnaires or participate in this study or could affect the interpretation of the results.
- Participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who maintain Eczema Area and Severity Index (EASI) ≤ 7 OR peak pruritus Numerical Rating Scale (NRS) ≤ 4 OR Dermatology Life Quality Index (DLQI) ≤ 5
Time frame: From Month 6 to Month 12
EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. DLQI is a questionaire with a score system of 0 to 30 the high score is indicative of poor QoL
Mean percent change from baseline in Atopic Dermatitis Control Tools (ADCT) score (≥12 years)
Time frame: From baseline to Week 52
Atopic dermatitis control tool (ADCT) is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision- making. ADCT questionnaire assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control. ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.
Mean percent change from baseline in Recap of atopic eczema (RECAP) score (6-11 years)
Time frame: From baseline to Week 52
Recap of atopic eczema (RECAP) is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. Patient's who turn 12 years during the course of study will continue to complete RECAP.
46 secondary outcomes
Incidence of treatment emergent adverse events (TEAEs) during the observation period
Time frame: From baseline up to 24 months
Incidence of dupilumab-related TEAEs during the observation period.
Time frame: From baseline up to 24 months
Event rate (per patient year) by type of TEAEs during the observation period.
Time frame: From baseline up to 24 months
Event rate (per patient year) by type of dupilumab related TEAEs during the observational period
Time frame: From Baseline up to 24 months
Treating physician reported effectiveness data: Change from baseline in IGA score after 6, 12, and 24 months dupilumab therapy
Time frame: From baseline up to 24 months
Treating physician reported effectiveness data.: Number of patients achieving EASI-75 (improvement in EASI score from baseline of ≥ 75%) after 6, 12 and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Treating physician reported effectiveness data: Absolute change from baseline in EASI score after 6, 12 and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Treating physician reported effectiveness data: Percentage change from baseline in EASI score after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Treating physician reported effectiveness data: Absolute change from baseline in IGA score after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Treating physician reported effectiveness data: Change from baseline in body surface area (BSA) after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on quality of life (QoL) data: Mean absolute change from baseline in Atopic Dermatitis Control Test (ADCT) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in ADCT score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Recap of atopic eczema (RECAP) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in RECAP score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM) score after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in POEM score after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Dermatology Life Quality Index/Children's Dermatology Life Quality Index (DLQI/CDLQI) score after 6, 12, and 24 months of dupilumab therapy.
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (CDLQI) score after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean Absolute Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance score after 6, 12, and 24 months of dupilumab therapy.
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean Percent Change from baseline in PROMIS sleep disturbance score after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in At baseline Questionnaire on Experience with Skin complaints (QES) score after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in At baseline Questionnaire on Experience with Skin complaints (QES) score after 6, 12, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Patient Global Assessment (PtGA) score after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in Patient Global Assessment (PtGA) score after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: : Mean percent change from baseline in Asthma control questionnaire-5 (ACQ-5)-Scores, assessed only in patients with co-existing Asthma after 3, 6, 9,12, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Asthma control questionnaire-5 (ACQ-5)-Scores, assessed only in patients with co-existing Asthma) after 3, 6, 9,12, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Mean absolute change from baseline in Allergic Visual analogue Scales ([Allergic-VAS] only patients with co-existing overall allergic symptoms) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Mean percent change from baseline in Allergic Visual Analogue Scales ([Allergic-VAS] only patients with co-existing overall allergic symptoms) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Time frame: From Baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in MACVIA-ARIA Sentinel Network Rhinitis Visual Analog Score (MASK-Rhinitis VAS score).
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in MACVIA-ARIA Sentinel Network Rhinitis Visual Analog Score (MASK-Rhinitis VAS score)
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in MACVIA-ARIA Sentinel Network conjunctivitis Visual Analog Score (MASK-conjunctivitis VAS score), after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy.
Time frame: From baseline up to 24 months
Mean percent change from baseline in MACVIA-ARIA Sentinel Network conjunctivitis Visual Analog Score (MASK-conjunctivitis VAS score) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Sinus Control Test (SCT) score, only assessed in patients with co-existing chronic rhinosinusitis after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in SCT score, only assessed in patients with co-existing chronic rhinosinusitis after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy
Time frame: From baseline up to 24 months
Patient and treatment characteristics reported by the physician or patient: Socio -demographic data
Time frame: At baseline
Patient and treatment characteristics reported by the physician or patient: Medical history of disease
Time frame: At baseline
Patient and treatment characteristics reported by the physician or patient: Comorbidities/smoker status/alcohol usage
Time frame: At baseline
Patient and treatment characteristics reported by the physician or patient: Prior systemic AD treatment (including balneophototherapy and/or UV therapy)
Time frame: At baseline
Patient and treatment characteristics reported by the physician or patient: Current topical and/or systemic AD treatment of the last 4 weeks before baseline visit (dosage, type)
Time frame: At baseline
Patient and treatment characteristics reported by the physician or patient: Current treatment for co-existing type 2 inflammatory and atopic diseases
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Sanofi at 55 sites in Germany.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of patients who maintain Eczema Area and Severity Index (EASI) ≤ 7 OR peak pruritus Numerical Rating Scale (NRS) ≤ 4 OR Dermatology Life Quality Index (DLQI) ≤ 5 (time frame: From Month 6 to Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.