Tralokinumab in combination with topical corticosteroids in subjects with severe atopic dermatitis who are not adequately controlled with or have contraindications to oral cyclosporine A ECZTRA 7 (ECZema TRAlokinumab trial no. 7)

Phase 1

• Conditions: Atopic Dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-000747-76-CZ
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-10
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

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.
* AD involvement of =10% body surface area at screening and baseline according to component A of SCORAD.
* Subjects who have a recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medications.
*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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

* Subjects for whom TCSs are medically inadvisable e.g., due to important side effects or safety risks
* 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 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.
* Known primary immunodeficiency disorder.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified