Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults with Atopic Dermatitis
- Conditions
- Atopic DermatitisMedDRA version: 18.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-003725-17-PL
- Lead Sponsor
- MedImmune Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 184
Inclusion Criteria
- Age 18-75 years
- Physician diagnosis of atopic dermatitis for > 1 year
- Atopic dermatitis involvement of = 10% body surface area
- EASI score of = 12
- SCORAD of = 25
- IGA score of = 3
- Effective birth control in line with protocol details
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
Exclusion Criteria
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant or breastfeeding
- History of cancer
- Previous receipt of tralokinumab
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method