EUCTR2017-002065-21-DE
Active, not recruiting
Phase 1
A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroid in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy
EO Pharma A/S0 sites369 target enrollmentFebruary 6, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- EO Pharma A/S
- Enrollment
- 369
- Status
- Active, not recruiting
- Last Updated
- 7 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.
- •Are the trial subjects under 18? no
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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