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
- -
A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy
- Conditions
- Atopic DermatitisAtopic Hand Eczema
- Interventions
- Drug: PlaceboDrug: Tralokinumab
- First Posted Date
- 2023-07-24
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 402
- Registration Number
- NCT05958407
- Locations
- 🇬🇧
LEO Pharma Investigational Site, London, United Kingdom
🇪🇸LEO Investigational Site, Badalona, Barcelona, Spain
🇪🇸LEO Investigational site, Barcelona, Spain
Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
- First Posted Date
- 2023-07-10
- Last Posted Date
- 2023-07-10
- Lead Sponsor
- University of California, San Diego
- Target Recruit Count
- 900
- Registration Number
- NCT05938478
- Locations
- 🇺🇸
University of California San Diego (UCSD), La Jolla, California, United States
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
- First Posted Date
- 2022-05-24
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 24
- Registration Number
- NCT05388760
- Locations
- 🇬🇧
LEO Pharma Investigational Site, Sheffield, United Kingdom
Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA)
- First Posted Date
- 2022-01-18
- Last Posted Date
- 2024-08-01
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 136
- Registration Number
- NCT05194540
- Locations
- 🇺🇸
LEO Pharma Investigational Site, Hialeah, Florida, United States
🇺🇸LEO Pharma Investigator, Webster, Texas, United States
Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- First Posted Date
- 2020-10-14
- Last Posted Date
- 2024-08-14
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 106
- Registration Number
- NCT04587453
- Locations
- 🇯🇵
LEO Investigational Site, Fukuoka, Japan
Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function
- First Posted Date
- 2020-09-21
- Last Posted Date
- 2023-04-21
- Lead Sponsor
- Prof. Dr. Stephan Weidinger
- Target Recruit Count
- 16
- Registration Number
- NCT04556461
- Locations
- 🇩🇪
UKSH, Campus Kiel, Kiel, Schleswig-Holstein, Germany
Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7
- First Posted Date
- 2018-12-03
- Last Posted Date
- 2024-08-01
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 277
- Registration Number
- NCT03761537
- Locations
- 🇬🇧
Leo Pharma Investigationel Site, Wakefield, United Kingdom
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
- First Posted Date
- 2018-07-16
- Last Posted Date
- 2024-08-05
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 1672
- Registration Number
- NCT03587805
- Locations
- 🇯🇵
LEO Pharma Investigational Site 1, Osaka, Japan
🇯🇵LEO Pharma Investigational Site 2, Osaka, Japan
🇬🇧LEO Pharma Investigational Site, Walsall, United Kingdom
Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
- Conditions
- Atopic Dermatitis
- Interventions
- First Posted Date
- 2018-06-19
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 215
- Registration Number
- NCT03562377
- Locations
- 🇨🇦
LEO Pharma Investigational Site, Verdun, Quebec, Canada
🇺🇸Leo Pharma Investigational Site, Spokane, Washington, United States
Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4
- Conditions
- Atopic Dermatitis
- Interventions
- First Posted Date
- 2018-06-14
- Last Posted Date
- 2024-10-26
- Lead Sponsor
- LEO Pharma
- Target Recruit Count
- 40
- Registration Number
- NCT03556592
- Locations
- 🇳🇱
LEO Pharma Investigational Site, Leiden, Netherlands
Drug Development Updates
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