Study on Tralokinumab for Moderate-to-Severe Atopic Hand Eczema in Patients Needing Systemic Therapy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Tralokinumab on a skin condition known as atopic hand eczema, which is a type of atopic dermatitis. Atopic hand eczema is a condition that causes the skin on the hands to become red, itchy, and inflamed. The study aims to evaluate how effective and safe Tralokinumab is when used as a treatment for people with moderate-to-severe atopic hand eczema who are candidates for systemic therapy, meaning they may need treatment that affects the entire body rather than just the skin.

Participants in the study will receive either Tralokinumab or a placebo, which is a substance with no active medication. The treatment involves receiving an injection of Tralokinumab every two weeks. The study will last for a period of 40 weeks, during which the participants’ skin condition will be monitored to see if there is an improvement in the severity and extent of their eczema. The goal is to determine if Tralokinumab can help clear or significantly reduce the symptoms of atopic hand eczema compared to the placebo.

Throughout the study, participants will be regularly assessed to track changes in their skin condition. The main focus will be on achieving a clear or almost clear skin condition by the 16th week of treatment. Additionally, the study will look at other improvements, such as a reduction in the severity of eczema symptoms. This research is important for understanding how well Tralokinumab works for treating atopic hand eczema and ensuring its safety for patients.

1 Joining the study

Upon joining the study, the patient will have already provided informed consent and met the necessary inclusion criteria, such as being 18 years or older and having a history of atopic dermatitis for at least 12 months.

The patient must have moderate-to-severe atopic hand eczema that has persisted for more than 3 months or returned multiple times within the last year.

2 Initial assessment

The patient will undergo an initial assessment to confirm the severity of the condition, which must be moderate-to-severe according to specific criteria.

The assessment will include a review of the patient’s medical history and current symptoms.

3 Treatment phase

The patient will receive tralokinumab 300 mg or a placebo every two weeks. The medication is administered through a subcutaneous injection.

This phase will last for 16 weeks, during which the patient will continue to receive the injections at the specified intervals.

4 Monitoring and evaluation

Throughout the treatment phase, the patient’s condition will be monitored regularly to evaluate the effectiveness of the treatment.

The primary goal is to achieve a score of 0 (clear) or 1 (almost clear) on a specific scale by Week 16.

5 Completion of treatment

At the end of the 16-week treatment period, the patient’s progress will be assessed to determine the overall effectiveness of the treatment.

Secondary outcomes include achieving significant reductions in specific eczema severity scores.

Who Can Join the Study?

  • You must sign and date a form that shows you understand the study and agree to participate.
  • You need to be at least 18 years old.
  • You should be willing to follow the rules and guidelines of the study.
  • You must have a diagnosis of atopic dermatitis, which is a type of skin condition, according to specific criteria.
  • You should have had atopic dermatitis for at least 12 months before joining the study.
  • You need to have atopic hand eczema that has lasted for more than 3 months or has come back at least twice in the last year, while avoiding things that irritate your skin.
  • Your skin condition should be considered moderate to severe at the start of the study.
  • You must have atopic dermatitis affecting at least one other part of your body besides your hands and wrists.
  • You need to follow a routine of using non-medicated skin care and avoid things that can irritate your skin throughout the study.
  • You should have a certain level of itchiness, measured by a score of 4 or higher, based on your itchiness over a week before starting the study.
  • You must have tried prescription creams or ointments for your hand eczema in the past year, but they didn’t work well enough, or you couldn’t use them due to side effects or safety concerns.
  • If you are a woman who can have children, you must use a very effective form of birth control during the study and for at least 16 weeks after the last treatment. This includes methods like certain birth control pills, devices, or procedures that are very reliable.

Who Cannot Join the Study?

  • Patients who do not have moderate-to-severe atopic hand eczema cannot participate. This means the skin condition on the hands must be of a certain severity.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
University Hospital Ostrava Ostrava Czechia
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Amphia Hospital Breda The Netherlands
Klinische Forschung Osnabrueck Osnabrück Germany
Saarland University Hospital Homburg Germany
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Mjoffndle Idkknhoofl Chjxdnpt Seacjtrf Snw z ojqv Warsaw Poland
Ccszqnivf Unjetqpbdwrsvf Spckkvrdj Woluwe-Saint-Lambert Belgium
Fvsdevba ncqfwgwhh Metwd a Hbybskn Prague Czechia
Umrbihverrznjbllxucxs Teildetpa Ato Tuebingen Germany
Eongyym Uqvnlyjfjwaa Mqxajxb Cmvldvu Ravkstwmf (irpwisz Mba Rotterdam The Netherlands
Nidxjdkib Amlg Natl Jqnvg arcr Novy Jicin Czechia
Snvntgboerz Ufbljjyuct Hxrrvxdhnvhgeeh Grmxehwiwtdadeqiz Gothenburg Sweden
Ujfgnugdmy Oy Apodius Edegem Belgium
Rlzcmn Opsqjbq Llfa Orebro Sweden
Umocprtguvvz Zathomkodm Gdjf Gent Belgium
Ursiqziqzint Mfjwquy Cbzqlbd Gpgrktfnd Groningen The Netherlands
Ckowkh Hqutuxzsenj Lcoz Sdj Pierre Benite France
Cbahdtf Nyznfnvargxq Tocqatw Dmggf Lvrrlm Sdk z omqr Cracow Poland
Cxmgrelk Bwvm Scrjculct Stm z oznh Sltq Lublin Poland
Mzypwanzm Ifgqr Ccrywjqpz Wroclaw Poland
Hbbzn Mznqhyv Ebmpbvuutv Cezxyl Mgtzk Mainz Germany
Dsnozlxgfylyuh azzgavuoh Predmesti Czechia
Gdiie Hlgtykf Dy Cqvfkddqb Gerpinnes Belgium
Dvsyuuuwj Cqgbmaxy Dp Sjsrnxx Di Svhjd Dse Ashmyd Toulon France
Cduvfc Hcatbwrneys Uachejdvztree Dl Dgpwl Dijon France
Abxhjqqzi Upv Amsterdam The Netherlands
Gkoegc Uzgajmqdth Fvldmqevq Frankfurt Germany
Cfrlex Hykzjhcpep Uccgllgqxnupe Dq Pfxhu Evltuq Porto Portugal
Kxoqaixpjo Uarofwdwbv Hfcqbrbs Stockholm Sweden
Kmixwavhcyr kguuqur nekpngdll awbn Karlovy Vary Czechia
Htxafoae Cuf Dyvvonybdxf Sxmd Lisbon Portugal
Tjbcxyuaxft ufg Sldxwnnmcad Blpiredc Ghti Bad Bentheim Germany
Cnkxdkc Mstxjpty Avzbeww Bpeednr Kbblwclki Cracow Poland
Dhupzoilvhmfvjrxan Fdyqvxtdpgtnxdb Gxcf Friedrichshafen Germany
Hpklkgxe Uvqncinvktieh Havdznje Tzmbt y Psxjxg Inyaomxz Cynbod dljochlmynuclcmhg (rffw Badalona Spain
Kzwpv awxzhuitk Kczmm Hznh ssfpum Hlouska Czechia
Chvhnln Kumsttgkgakkkfpjmv Jtjmlugmvir Bjgnilbvjnvkikyqsdltpylx Lkjlkxe szhyn Elblag Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
04.12.2023
Czechia Czechia
Not recruiting
04.12.2023
France France
Not recruiting
04.12.2023
Germany Germany
Not recruiting
04.12.2023
Poland Poland
Not recruiting
04.12.2023
Portugal Portugal
Not recruiting
04.12.2023
Spain Spain
Not recruiting
04.12.2023
Sweden Sweden
Not recruiting
04.12.2023
The Netherlands The Netherlands
Not recruiting
04.12.2023

Trial locations

Investigated Drugs:

Tralokinumab is a medication being studied for its effectiveness in treating moderate-to-severe atopic hand eczema. It is used as a monotherapy, which means it is given alone without any other medications. The goal of using tralokinumab in this trial is to see how well it can reduce the severity and spread of eczema on the hands. This medication is administered every two weeks to participants who are candidates for systemic therapy, meaning they need treatment that affects the entire body rather than just the skin.

Investigated Diseases:

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. Flare-ups can occur periodically, often triggered by environmental factors or stress. The condition is associated with a malfunction in the skin barrier and immune system, leading to increased sensitivity to irritants and allergens. It is commonly found in individuals with a family history of allergies or asthma.

Atopic Hand Eczema – Atopic hand eczema is a form of eczema that specifically affects the hands, causing them to become dry, itchy, and inflamed. It is often seen in individuals with a history of atopic dermatitis or other allergic conditions. The skin on the hands may crack, blister, or peel, leading to discomfort and difficulty in performing daily tasks. This condition can be exacerbated by frequent hand washing, exposure to irritants, or changes in weather. It tends to be persistent and may require ongoing management to control symptoms. The condition can significantly impact the quality of life due to its visibility and the functional importance of the hands.

Trial ID:
2022-502653-34-01
Protocol code:
LP0162-2328
Trial Phase:
Human Pharmacology (Phase I) – Other

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