A phase 3 trial to evaluate the efficacy and safety of tralokinumab in adults with moderate to severe atopic dermatitis
- 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
- EUCTR2016-004200-65-FR
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 780
• 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
• 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
- Primary Outcome Measures
Name Time Method <br> Main Objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate-to-severe Atopic dermatitis.<br> <br> ;<br> Secondary Objective: During the initial treatment period:<br> - To evaluate the efficacy of tralokinumab on severity and extent of AD, itch,<br> and health related quality of life compared with placebo.<br> <br> During the maintenance treatment period:<br> - To evaluate maintenance of effect with continued tralokinumab dosing up to<br> 52 weeks compared to placebo for subjects achieving clinical response at 16 weeks.<br> ;<br> Primary end point(s): For the initial treatment period:<br> - IGA score of 0 (clear) or 1 (almost clear) at Week 16<br> - EASI75 at Week 16<br> ;Timepoint(s) of evaluation of this end point: Bi-weekly throughout study.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Bi-weekly throughout study for assessment conducted by the HCP. For Puritus the assessment is done on a daily basis using an eDiary. For DLQI completed by the subject every 2, 4 or 8 weeks.;<br> Secondary end point(s): For the initial treatment period:<br> Severity and extent of AD: Change in SCORAD from baseline to Week 16 <br> Itch: Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4<br> from baseline to Week 16. <br> Quality of life: Change in DLQI score from baseline to Week 16<br> <br> For the maintenance treatment period:<br> IGA of 0/1 at Week 52 among subjects with IGA of 0/1 at Week 16 after initial randomisation to tralokinumab<br> EASI75 at Week 52 among subjects with EASI75 at Week 16 after initial randomisation to tralokinumab<br>