Status:
COMPLETED
Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adeq...
Eligibility Criteria
Inclusion
- Key
- Age 18 and above
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
- History of AD for 1 year or more
- Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
- AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
- Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
- Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation
- Key
Exclusion
- Subjects for whom TCSs are medically inadvisable in the opinion of the investigator
- Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
- Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
- Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
- Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
- History of any active skin infection within 1 week prior to randomisation
- History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
- A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
- Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
- History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2020
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT03761537
Start Date
December 13 2018
End Date
September 28 2020
Last Update
March 11 2025
Active Locations (74)
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1
Leo Pharma Investigationel Site
Brussels, Belgium, 1090
2
Leo Pharma Investigationel Site
Brussels, Belgium, 1200
3
Leo Pharma Investigationel Site
Edegem, Belgium, 2650
4
Leo Pharma Investigationel Site
Ghent, Belgium, 9000