A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab

Atopic Dermatitis Clinical Trial

— DUPILAB  

Official title:

French Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169527
• Other study ID #: OBS17668
• Secondary ID: U1111-1279-3469O
• Status: Recruiting
• Start date: November 28, 2023
• Est. completion date: November 29, 2027

Study information

• Verified date: December 2023
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a long-term study to collect data over 3 years in order to find out what is likely to happen in the future regarding participants 6 years of age and older who receive dupilumab for Atopic Dermatitis (AD) commonly known as Eczema, and to characterize real-world effectiveness, safety and use patterns of dupilumab in real world setting in France. Patients will be invited to participate if initiating treatment with dupilumab for AD according to French-specific prescribing information. The decision of initiation of the treatment is independent to the study's participation. The study will be conducted in approximately 50 centers in France to evaluate a representative sample of patients treated in France. At each participating site, all AD participants who receive an initial prescription for dupilumab will be invited to participate in this study, until the enrollment goal is achieved.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 29, 2027
• Est. primary completion date: November 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Male or female, 6 years or older.
• Initiating treatment with dupilumab for AD according to French-specific prescribing information (= 12 years old: moderate to severe AD versus 6-11 years old: severe AD). The decision of initiation of the treatment is independent to the study's participation.
• Able to understand and complete study-related questionnaires.
• Signed informed consent form. For participants <18 years old, Informed consent form signed by the parent/legal guardian and participant's assent obtained.

Exclusion Criteria:

• Patients who have a contraindication to the drug according to the French-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 comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments.
• Patients currently participating in any interventional clinical trial.
• Patients previously treated with dupilumab.
• Patients under tutorship or curatorship; patients under safeguard of justice or deprived of his/her liberty by an administrative or court decision.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Dupilumab
Dupilumab cohort

Locations

Country	Name	City	State
France	Investigational Site Number: 2500021	Argenteuil
France	Investigational Site Number: 2500006	Clermont Ferrand
France	Investigational Site Number: 2500016	Pau
France	Investigational Site Number: 2500026	Saint Nazaire

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic characteristics of participants who receive dupilumab for AD	Including age, gender, educational level, socio-professional category	At baseline
Primary	Weight characteristics of participants who receive dupilumab for AD		At baseline
Primary	Height characteristics of participants who receive dupilumab for AD		At baseline
Primary	Medical history characteristics of participants who receive dupilumab for AD	including previous treatments for AD, relevant medical history, family history of atopy	At baseline
Primary	Comorbidities and treatments change from baseline		At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Atopic comorbidities and treatments change from baseline		At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change from baseline in lifestyle habits of participants who receive dupilumab for AD	Including alcohol, tobacco, CBD and cannabis consumption	At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36 if applicable
Primary	Change from baseline in dupilumab dose		At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change from baseline in dupilumab administration		At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change from baseline in dupilumab compliance with treatment		At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change from baseline in dupilumab temporary or permanent discontinuation		At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change from baseline in dupilumab treatment switch to another therapy		At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change from baseline in dupilumab treatment for concomitant AD treatments		At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in patient's treatment satisfaction score using the Patient Global Assessment of Treatment Effect (PGATE)	PGATE for patients = 12 years of age: an internally developed and validated instrument allowing patients to rate their opinion and perceived treatment effect. Ratings are on a 5-point Likert scale from 1 being "Poor" and 5 being "Excellent".	At month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in eczema severity using the Eczema Area and Severity Index (EASI)	EASI is a validated measure used to assess severity and extent of AD at each body region by multiplying the lesions characteristics score x the body area score x multiplier. Four AD disease characteristics -erythema, thickness (induration, population, and oedema), scratching (excoriation), and lichenification - will each be assessed for severity by the observing physician, as follows: 0 = none, absent; 1=mild (just perceptible); 2=Moderate (obvious); 3=Severe. The area score ranges from 0 to 6 is determined as follows: 0= 0% (no active eczema in region); 1= 1-9%; 2= 10-29%; 3= 30-49%; 4= 50-69%; 5= 70-89%; 6= 90-100% (entire region affected by eczema). The multiplier is determined according to the region affected and the age of the patient: 0.1 or 0.2 for patients < 8 years old (head/neck), 0.2 (upper limbs), 0.3 (trunk), 0.4 or 0.3 for patients < 8 years old (lower limbs). A higher score means higher AD severity. Scores range from 0 (no disease) to 72 (maximal disease severity).	At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in AD disease control using the Atopic Dermatitis Control Tool (ADCT)	ADCT for patients aged = 12 years of age: a validated, brief and easily scored tool consisting of six concise questions allowing to rate the different dimensions of patient-perceived AD control, to foster communication between patients and their physicians and help appropriate decision-making. The instrument includes 6 items, with a 7-day recall period: overall severity of symptoms, frequency of intense episodes of itching, severity of bother, frequency of sleep impact, severity of daily activities impact and severity of mood or emotions impact. Each item is rated on a 5-point Likert scale, ranging from 0 (none/ not at all/ no nights) to 4 (very severe/ everyday/ extremely/ every night); the total score ranges from 0 to 24, which is the summation of the responses to all the items. A total score of =7 points was derived as the threshold to identify patients "not in control", based on optimal sensitivity/ specificity values. The higher the score, the less AD is controlled.	At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in Worst-Itch Numeric Rating Scale (WI-NRS)	WI-NRS will be rated from 0 to 10 on average during the past 7 days (adult, pediatric and adolescent patients), completed by the observing physician after questioning of patient; 0 = no itch and 10 = the worst imaginable itch.	At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in sleep disturbance NRS	NRS sleep disturbance will be rated from 0 to 10 on average during the past 7 days (adult, pediatric and adolescent patients), completed by the observing physician after questioning of patient; 0 = "sleep not disturbed at all" (best possible sleep) and 10 = "sleep extremely disturbed (worst possible sleep)".	At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in global patient's disease evaluation using the Patient Global Assessment of Disease Severity (PGADS)	PGADS for patients = 12 years of age: an internally developed and validated instrument allowing to the patients to rate their AD-related overall well-being. Patients will be asked: "Considering all the ways in which your eczema affects you, how well are you doing?" Response choices will be from 1 being "Poor" to 5 being "Excellent".	At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in global patient's disease evaluation using the Caregiver Global Assessment of Disease (CGAD)	CGAD for patients 6 to 11 years of age: an internally developed and validated instrument allowing to the caregivers to rate their child's AD-related overall well-being. Caregivers will be asked: "Considering all the way in which the eczema affects your child, how well is your child doing?". Response choices will be 1 being "Poor" to 5 being "Excellent".	At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in Dermatology Life Quality Index (DLQI)	DLQI for patients = 16 years (or cDLQI for patients < 16 at baseline) are 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life in adults and pediatrics, respectively. The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 items, which assess quality of life over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor quality of life. Patients 6-11 years old will be assisted for questionnaire completion. A cDLQI's cartoon version could be also used for patients from 6 to 11 years old. If a patient turns 16 years old during the study, they will switch to DLQI.	At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in European Quality of Life-5 Dimensions-3 level score (EQ-5D-3L)	The EQ-5D-3L consists of 2 parts: The EQ-5D descriptive system has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 3 levels: no problems, some problems, and extreme problems. The patient selects the most appropriate statement in each of the five dimensions, resulting in a 1-digit number for each dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.; The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scale is numbered 0 to 100. A higher value represents better health and a lower value represents worse health.	At baseline, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change in Work Productivity and Activity Impairment Questionnaire, Atopic Dermatitis (WPAI-AD)	WPAI-AD for adults and WPAI-CIQ-AD for adolescents is a questionnaire designed to assess the impact of AD on the patient's productivity. The WPAI-AD is the version of the original generic WPAI that is specific to AD. It is a 6-item, validated questionnaire to measure impairments in work and activities over a 7-day recall period. The WPAI-AD outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. If a patient turns 18 years old during the study, this one will switch to WPAI-AD.	At month 6, month 12, month 18, month 24, month 30, month 36
Primary	Number of Adverse Events (AE)	AEs for dupilumab and/or concomitant treatments will be collected throughout the study.	At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Primary	Change from baseline in Drug Survival	Drug survival is defined as the time from the start of treatment to the end or discontinuation of treatment with no changes. If a patient has multiple drug survival events for the same treatment, the longest drug survival will be used in the data summarization. The drug survival will be illustrated using a Kaplan-Meier plot.	At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36