Dupilumab Phase 4 Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 6/30/2018 |
| Start Date: | October 16, 2017 |
| End Date: | March 31, 2027 |
Dupilumab Registry Study
The investigators will monitor for the incidence of adverse-events in a prospective,
longitudinal, non-interventional and observational real-world sub-study of adults patients
with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.
longitudinal, non-interventional and observational real-world sub-study of adults patients
with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.
The investigators will conduct a prospective, longitudinal, non-interventional and
observational sub-study of patients receiving dupilumab as normal standard-of-care treatment
to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the
treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid
health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab
will lead to improved long-term control and decreased severity of AD, and that long-term
monitoring will shed light on the incidence of adverse drug events.
observational sub-study of patients receiving dupilumab as normal standard-of-care treatment
to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the
treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid
health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab
will lead to improved long-term control and decreased severity of AD, and that long-term
monitoring will shed light on the incidence of adverse drug events.
Inclusion Criteria:
- Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are
using dupilumab therapy as part of standard of care.
- Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis
and are receiving dupilumab off-label for the management of AD.
Exclusion Criteria:
- Patients not on dupilumab
- Those who do not comply with the study requirements
- Those who do not provide informed consent
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