A phase 3 trial to evaluate the efficacy and safety of tralokinumab in adults with moderate to severe atopic dermatitis (ECZTRA 2)

Phase 1

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

• Registration Number: EUCTR2016-004201-13-PL
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-10
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• Age 18 and above
• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
• Diagnosis of AD for =1 year.
• Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
• 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 numeric rating scale (NRS) average score of =4
during the week prior to baseline.
• Stable dose of emollient twice daily 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 740
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• 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 and/or TCI within 2 weeks prior to randomisation.
• 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