A phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroid in adults with moderate to severe atopic dermatitis. ECZTRA 3 (ECZema TRAlokinumab trial no. 3)

Phase 1

• Conditions: Atopic Dermatitis; MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-002065-21-ES
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-30
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 492

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
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

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.
Known primary immunodeficiency disorder.

Study & Design

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