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About
The main objective of the trial is to evaluate the efficacy of 2 dose regimens of dupilumab compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral Cyclosporine A (CSA), or when this treatment is currently not medically advisable.
The secondary objective is to assess the safety and tolerability of 2 dose regimens of dupilumab compared to placebo, administered with concomitant TCS, in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when this treatment is currently not medically advisable.
Enrollment
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Ages
Volunteers
Inclusion criteria
Male or female, 18 years or older
Severe, Chronic AD, (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]) for whom treatment with potent TCS is indicated
EASI score ≥20 at the screening and baseline visits
IGA score ≥3 (on the 0 to 4 IGA scale) at the screening and baseline visits
≥10% body surface area (BSA) of AD involvement at the screening and baseline visits
Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with TCS
Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit
Documented history by a physician of either:
No prior CSA exposure and not currently a candidate for CSA treatment due to:
Previously exposed to CSA, and CSA treatment should not be continued or restarted due to:
Exclusion criteria
Participation in a prior dupilumab clinical study
Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the screening visit
Hypersensitivity and/or intolerance to corticosteroids or to any other ingredients contained in the TCS product used in the study
Systemic CSA, systemic corticosteroids, or phototherapy within 4 weeks prior to screening, and azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors within 8 weeks prior to screening
Treatment with TCI within 1 week before the screening visit
Treatment with biologics as follows:
Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit
Treatment with a live (attenuated) vaccine within 12 weeks before the screening
Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the screening or superficial skin infections within 1 week before the screening visit. NOTE: patients may be rescreened no sooner than 2 weeks after infection resolves
Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, Listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment
Presence of any 1 of the following TB criteria:
NOTE: Any of these 3 TB tests will be performed on a country-by-country basis according to local guidelines only if required by regulatory authorities or ethics boards.
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab), or hepatitis C antibody (HCV Ab) at the screening visit
Primary purpose
Allocation
Interventional model
Masking
325 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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