Phase 2
Completed N=31
Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)
Source: ClinicalTrials.gov NCT01639040 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) — 70.0; 57.1; 40.0; 28.6 percentage of participants
Summary
The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) |
70.0; 57.1; 40.0; 28.6; 10.0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients aged 18 years or older
- Chronic AD that had been present for at least 2 years
Exclusion Criteria
- Prior treatment with Dupilumab
- Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
- AD lesions located on face, flexural, and genital areas
- Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- Treatment with an investigational drug within 8 weeks
- Known history of human immunodeficiency virus (HIV) infection
- Presence of certain laboratory abnormalities at the screening visit
- History of certain opportunistic infections or certain clinical parasite infections
- History of malignancy within 5 years before the baseline visit, with certain exceptions
- Pregnant or breast-feeding women
- Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
- History of alcohol or drug abuse within 2 years of the screening visit
- Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
Data sourced from ClinicalTrials.gov (NCT01639040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.