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Monoclonal Antibodies
Dupilumab SAR231893 for Atopic Dermatitis (PELISTAD Trial)
Phase 4
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Awards & highlights
PELISTAD Trial Summary
This trial is looking at how well a medication works in treating atopic dermatitis in children. The medication will be given to children with atopic dermatitis, and then the children's skin will be tested for improvement.
Eligible Conditions
- Atopic Dermatitis
PELISTAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16
Secondary outcome measures
Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197
Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197
Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197
+37 moreSide effects data
From 2021 Phase 4 trial • 52 Patients • NCT0444741712%
Ecchymosis
8%
Limb Injury
8%
Myalgia
8%
Medical Device Site Haemorrhage
4%
Abdominal Pain
4%
Upper Respiratory Tract Infection
4%
Medical Device Site Pain
4%
Anxiety
4%
Dental Restoration Failure
4%
Petechiae
4%
Medical Device Site Urticaria
4%
Back Pain
4%
Pain In Extremity
4%
Covid-19
4%
Food Poisoning
4%
Tooth Abscess
4%
Dermatitis
4%
Medical Device Site Erythema
4%
Blood Pressure Abnormal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteer
Atopic Dermatitis Patients
PELISTAD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Atopic Dermatitis ParticipantsExperimental Treatment1 Intervention
Pediatric participants with moderate-to-severe atopic dermatitis (AD) and with baseline body weight more than or equal to (>=) 15 kilograms (kg) and less than (<) 30 kg received a subcutaneous (SC) loading dose of dupilumab 600 milligrams (mg) (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection every 4 weeks (Q4W), from Week 4 to Week 12. Pediatric participants with body weight >=30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection every 2 weeks (Q2W), from Week 2 to Week 14.
Group II: Healthy VolunteersActive Control1 Intervention
Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD participants, received no treatment, but were monitored in a similar way as AD participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab SAR231893
2021
Completed Phase 4
~2070
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,162 Previous Clinical Trials
3,512,032 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,793 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,915 Total Patients Enrolled
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