Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
Status: | Enrolling by invitation |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | Any - 17 |
Updated: | 3/27/2019 |
Start Date: | October 15, 2015 |
End Date: | November 16, 2023 |
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis
The primary objective of the study is to assess the long-term safety of dupilumab in
pediatric participants with AD.
The secondary objectives of the study are:
- To assess the long-term efficacy of dupilumab in pediatric participants with AD
- To assess the trough concentrations of functional dupilumab in serum and the
immunogenicity in pediatric participants with AD after re-treatment with dupilumab.
pediatric participants with AD.
The secondary objectives of the study are:
- To assess the long-term efficacy of dupilumab in pediatric participants with AD
- To assess the trough concentrations of functional dupilumab in serum and the
immunogenicity in pediatric participants with AD after re-treatment with dupilumab.
Key Inclusion Criteria:
1. Participated in a prior dupilumab study in pediatric patients with AD and adequately
completed the visits and assessments required for both the treatment and follow-up periods,
as defined in the prior study protocol
Key Exclusion Criteria:
1. Patients who, during their participation in a prior dupilumab study developed an
adverse event (AE) or serious adverse event (SAE) deemed related to study drug which
could indicate that continued treatment with study drug may present an unreasonable
risk for the patient
2. Patients, who during the participation in a prior Dupilumab study, developed an AE
that was deemed related to study drug and led to study treatment discontinuation,
which in the opinion of the investigator or medical monitor could indicate that
continued treatment with study drug may present an unreasonable risk for the patient
3. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within
5 half-lives (if known), whichever is longer, before the baseline visit
4. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the
baseline visit
5. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
6. Diagnosed active endoparasitic infections or at high risk of these infections
7. Severe concomitant illness(es) that, in the investigator's judgment, would adversely
affect the patient's participation in the study.
Note: Other protocol defined Inclusion / Exclusion criteria may apply
We found this trial at
48
sites
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