Tralokinumab for Atopic Hand Eczema
(ADHAND Trial)
Recruiting in Palo Alto (17 mi)
+66 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: LEO Pharma
Must not be taking: Immunosuppressives, Corticosteroids, Biologics, others
Disqualifiers: Contact dermatitis, Phototherapy, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life.
The trial will last for up to 40 weeks. There will be up to 15 visits, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants are off the drug for safety follow-up.
Will I have to stop taking my current medications?
Yes, you may need to stop certain medications. The trial requires stopping some treatments like systemic immunosuppressive drugs, corticosteroids, and certain topical treatments before starting the trial.
What data supports the effectiveness of the drug Tralokinumab for treating atopic hand eczema?
Tralokinumab has been shown to be effective in treating moderate-to-severe atopic dermatitis, a similar skin condition, by improving symptoms and quality of life in clinical trials. It works by targeting and neutralizing interleukin-13, a protein involved in inflammation, and has been approved for use in adults with atopic dermatitis.
12345Is Tralokinumab safe for humans?
Tralokinumab, also known as Adbry or Adtralza, has been shown to be generally well tolerated in adults with moderate to severe atopic dermatitis. Most side effects, like injection-site reactions and conjunctivitis (eye inflammation), were mild to moderate in severity.
12367How is the drug Tralokinumab unique for treating atopic hand eczema?
Tralokinumab is unique because it is a monoclonal antibody that specifically targets and neutralizes interleukin-13, a protein involved in inflammation, which is different from traditional treatments like topical corticosteroids. This targeted approach may offer a new option for patients with atopic hand eczema, especially those who need systemic therapy.
12345Eligibility Criteria
Adults over 18 with moderate-to-severe atopic hand eczema, unresponsive to or unsuitable for topical treatments, and a history of atopic dermatitis. Participants must have had eczema on their hands for more than 3 months or recurrent episodes and other body areas affected. They should not have used certain therapies before joining the trial.Inclusion Criteria
My skin condition didn't improve with prescribed creams or they were not suitable for me.
I have been diagnosed with atopic dermatitis.
You have an average weekly itch score of 4 or higher at the beginning of the study.
+5 more
Exclusion Criteria
I haven't taken any biological therapy, including dupilumab, in the last 3-6 months.
I haven't used tanning beds, phototherapy, or bleach baths on my hands or wrists recently.
My hand eczema is not caused by allergies, irritants, or other skin conditions.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
1 visit (in-person)
Treatment (Double-blinded)
Participants receive either tralokinumab or placebo injections every two weeks
16 weeks
6 visits (in-person), 2 visits (phone)
Treatment (Open-label)
All participants receive tralokinumab injections every two weeks
16 weeks
6 visits (in-person), 1 visit (phone)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
The study tests Tralokinumab's safety and effectiveness against placebo in treating atopic hand eczema over 32 weeks. Initially, participants receive either Tralokinumab or placebo biweekly for 16 weeks; afterwards, all get Tralokinumab for another 16 weeks.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TralokinumabExperimental Treatment1 Intervention
Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period)
Group II: Placebo + tralokinumabPlacebo Group1 Intervention
Placebo is administered for 16 weeks (double-blinded period) prior to roll-over to a 16 weeks open-label period where tralokinumab is administered
Tralokinumab is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Adbry for:
- Moderate-to-severe atopic dermatitis
🇪🇺 Approved in European Union as Adtralza for:
- Moderate-to-severe atopic dermatitis
🇨🇦 Approved in Canada as Adtralza for:
- Moderate-to-severe atopic dermatitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
LEO Investigational SiteDetroit, MI
LEO Pharma Investigational SiteSan Antonio, TX
LEO Pharma Investigational SiteHialeah, FL
LEO Pharma Investigational SiteSacramento, CA
More Trial Locations
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Who Is Running the Clinical Trial?
LEO PharmaLead Sponsor
References
Tralokinumab in Atopic Dermatitis: A Profile of Its Use. [2022]Tralokinumab (tralokinumab-ldrm) [Adbry™ (USA); Adtralza® (EU)], a human IgG4 monoclonal antibody that binds specifically to interleukin (IL)-13, is an effective and generally well tolerated treatment option for adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. In pivotal phase III trials, subcutaneous tralokinumab improved the clinical signs and symptoms of atopic dermatitis as well as quality of life (QOL). In ECZTRA 1 and 2, tralokinumab monotherapy was superior to placebo in the first 16 weeks of treatment, with improvements in pruritus and sleep scores seen as early as week 1. Many patients who met the criteria for clinical response at week 16 maintained this response at week 52. Tralokinumab was also more effective than placebo when used in combination with 'as needed' topical corticosteroids (TCS) in ECZTRA 3 and 7; most tralokinumab recipients used no or very little amounts of TCS. In an open-label extension trial, tralokinumab provided consistent symptom control over the longer term (up to 2 years). The majority of adverse events with tralokinumab, including injection-site reactions and conjunctivitis, were of mild to moderate severity. The tolerability profile of tralokinumab longer term was consistent with that in the phase III trials.
Tralokinumab for Moderate-to-Severe Atopic Dermatitis in Adults. [2023]Atopic dermatitis (AD) is a common, chronic, recurrent, immune-mediated inflammatory skin disease. Targeted treatment options remain limited. Tralokinumab (Adtralza®) is a promising, new systemic therapy that inhibits interleukin-13. It was recently approved by Health Canada and the US FDA for the treatment of moderate-to-severe AD in adults and may be used alone or with topical corticosteroids. Herein, we review the efficacy and safety of tralokinumab in adults, as demonstrated in clinical trials.
Tralokinumab: First Approval. [2022]Tralokinumab (Adtralza®) is a human IgG4 monoclonal antibody being developed by LEO Pharma for the treatment of atopic dermatitis. The T-helper cytokine IL-13 is thought to play a key role in the pathogenesis of atopic dermatitis. Tralokinumab specifically binds with high affinity to IL-13, inhibiting its interaction with the IL-13 receptor and thereby neutralising the biological activity of the cytokine. Based on results from the ECZTRA 1-3 trials, tralokinumab has recently been approved in the EU for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. This article summarizes the milestones in the development of tralokinumab leading to this first approval for atopic dermatitis.
Safety of tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled phase II and phase III trials. [2023]Tralokinumab is a fully human monoclonal antibody that neutralizes the activity of interleukin-13, a key pathogenic driver of atopic dermatitis (AD). Clinical trials including adults with moderate-to-severe AD, of up to 52 weeks' duration, showed tralokinumab was efficacious and well tolerated.
Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). [2021]Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin-13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms.
Review of Tralokinumab in the Treatment of Atopic Dermatitis. [2023]To review pharmacokinetics, efficacy, and safety of tralokinumab in treatment of atopic dermatitis (AD).
New Drug for Atopic Dermatitis. [2023]Tralokinumab-ldrm (Adbry) is now approved for the treatment of moderate to severe atopic dermatitis in adults whose disease has not been controlled by topical therapies.Nurses and NPs should teach patients how to administer the drug subcutaneously and that more than one injection is needed to fulfill the prescribed dose.