NL-OMON46483
Completed
Phase 3
A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy - ECZTRA 3
TFS Trial Form Support BV0 sites43 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- TFS Trial Form Support BV
- Enrollment
- 43
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Age 18 and above.
- •\* Diagnosis of AD as defined by the Hanifin and Rajka (1980\) criteria for AD.
- •\* History of AD for \*1 year.
- •\* Subjects who have a recent history of inadequate response to treatment with topical medications.
- •\* AD involvement of \*10% body surface area at screening and baseline.
- •\* An EASI score of \*12 at screening and 16 at baseline.
- •\* An IGA score of \*3 at screening and at baseline.
- •\* A Worst Daily Pruritus NRS average score of \*4 during the week prior to baseline.
- •\* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
Exclusion Criteria
- •\* Subjects for whom TCSs are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
- •\* Active dermatologic conditions that may confound the diagnosis of AD.
- •\* Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
- •\* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
- •\* Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE\-4\) inhibitor within 2 weeks prior to randomisation.
- •\* Receipt of any marketed biological therapy (i.e. immunoglobulin, anti\- immunoglobulin E) including dupilumab or investigational biologic agents.
- •\* Active skin infection within 1 week prior to randomisation.
- •\* Clinically significant infection within 4 weeks prior to randomisation.
- •\* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- •\* Tuberculosis requiring treatment within the 12 months prior to screening.
Outcomes
Primary Outcomes
Not specified
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