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 appar...

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

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

and more 1 locations

Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT

Recruiting
Conditions
Interventions
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)

Phase 2
Active, not recruiting
Conditions
Interventions
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)

Phase 3
Completed
Conditions
Interventions
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

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

Phase 2
Completed
Conditions
Interventions
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

Phase 3
Completed
Conditions
Interventions
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

Phase 3
Completed
Conditions
Interventions
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)

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

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

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