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)
- Conditions
- Atopic DermatitisMedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-002065-21-BE
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 369
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
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
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that tralokinumab in combination with TCS is superior to placebo in combination with TCS in treating moderate-to-severe AD.;<br> Secondary Objective: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS.<br><br> To assess safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.<br> ;<br> Primary end point(s): Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16.<br> At least 75% reduction in Eczema Area and Severity Index (EASI) score from baseline (EASI75) at Week 16.<br> ;Timepoint(s) of evaluation of this end point: Week 16
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16.<br> Reduction of Worst Daily Pruritus numeric rating scale (NRS) (weekly average) of at least 4 from baseline to Week 16.<br> Change in Dermatology Life Quality Index (DLQI) from baseline to Week 16.<br> ;Timepoint(s) of evaluation of this end point: Week 16