Tralokinumab
- Generic Name
- Tralokinumab
- Brand Names
- Adbry, Adtralza
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1044515-88-9
- Unique Ingredient Identifier
- GK1LYB375A
- Background
Atopic dermatitis (AD) is an inflammatory skin disorder that causes skin inflammation, skin barrier dysfunction, and chronic pruritus. It is estimated to affect up to 20% of adults and children worldwide, and is frequently associated with other atopic conditions such as asthma or allergic rhinitis. While AD is a heterogenous condition with a variety of apparent genetic and environmental causes, it is primarily driven by the pro-inflammatory cytokine interleukin-13 (IL-13).
Tralokinumab is a fully human IgG4 monoclonal antibody targeted against IL-13. It neutralizes IL-13 activity by inhibiting its ability to bind with receptors, thus helping to alleviate AD symptoms. Tralokinumab was first approved for the treatment of atopic dermatitis by the EMA in June 2021, under the brand name Adtralza (Leo Pharma), and was subsequently approved in Canada in October 2021 and the US in December 2021.
- Indication
Tralokinumab is indicated in Canada, the US, and the EU for the treatment of moderate-to-severe atopic dermatitis in patients who are candidates for systemic therapy and are inadequately controlled with topical interventions. In Canada and US, tralokinumab is only approved for adults. In Europe, it is approved for use in patients 12 years of age and older.
- Associated Conditions
- Moderate to Severe Atopic Dermatitis
- Associated Therapies
- -
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
- First Posted Date
- 2018-05-16
- Last Posted Date
- 2024-08-29
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 301
- Registration Number
- NCT03526861
- Locations
- 🇬🇧
Leo Pharma Investigationel Site, London, United Kingdom
🇧🇪Leo Pharma Investigational Site, Maldegem, Belgium
🇨🇦LEO Pharma Investigational Site, Saskatoon, Saskatchewan, Canada
Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
- First Posted Date
- 2017-12-06
- Last Posted Date
- 2024-08-01
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 380
- Registration Number
- NCT03363854
- Locations
- 🇪🇸
Fundación Hospital Alcorcón, Madrid, Spain
🇪🇸Hospital General de Valencia, Valencia, Spain
🇩🇪St. Josef-Hospital, Ruhr-Universitet, Bochum, Germany
Molecular Signatures in Inflammatory Skin Disease
- Conditions
- Atopic DermatitisPsoriasis
- Interventions
- First Posted Date
- 2017-11-30
- Last Posted Date
- 2024-12-04
- Lead Sponsor
- Prof. Dr. Stephan Weidinger
- Target Recruit Count
- 300
- Registration Number
- NCT03358693
- Locations
- 🇩🇪
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany
Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)
- First Posted Date
- 2017-05-19
- Last Posted Date
- 2024-08-01
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 794
- Registration Number
- NCT03160885
- Locations
- 🇺🇸
Modern Research Associates, PLLC, Dallas, Texas, United States
🇺🇸USC Department of Dermatology, Los Angeles, California, United States
🇺🇸Paddington Testing Company, Inc., Philadelphia, Pennsylvania, United States
Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)
- First Posted Date
- 2017-04-27
- Last Posted Date
- 2024-08-01
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 802
- Registration Number
- NCT03131648
- Locations
- 🇺🇸
Dermatology Research Associates, Los Angeles, California, United States
🇺🇸PMG Research of Christie Clinic, Chicago, Illinois, United States
🇺🇸University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata
- First Posted Date
- 2016-02-17
- Last Posted Date
- 2020-01-07
- Lead Sponsor
- Emma Guttman
- Target Recruit Count
- 22
- Registration Number
- NCT02684097
- Locations
- 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
- First Posted Date
- 2011-12-01
- Last Posted Date
- 2016-04-05
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 147
- Registration Number
- NCT01482884
- Locations
- 🇬🇧
Research Site, Shrewsbury, United Kingdom
Drug Development Updates
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