Tralokinumab for Atopic Hand Eczema (ADHAND Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: LEO Pharma
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.
What safety data is available for Tralokinumab in treating atopic dermatitis?Tralokinumab, also known as Adbry or Adtralza, has been evaluated in several phase III trials (ECZTRA 1, 2, 3, and 7) for its safety and efficacy in treating moderate to severe atopic dermatitis. The trials showed that Tralokinumab is generally well tolerated, with most adverse events being mild to moderate, such as injection-site reactions and conjunctivitis. Long-term safety data from an open-label extension trial indicated consistent symptom control over up to 2 years, with a tolerability profile consistent with the phase III trials.23458
Is the drug Tralokinumab a promising treatment for Atopic Hand Eczema?Yes, Tralokinumab is a promising drug for treating atopic hand eczema. It has been shown to improve symptoms and quality of life for people with moderate to severe atopic dermatitis, a condition similar to atopic hand eczema. Clinical trials have demonstrated its effectiveness and safety, leading to its approval in several countries.12367
What data supports the idea that Tralokinumab for Atopic Hand Eczema is an effective treatment?The available research shows that Tralokinumab is effective for treating atopic dermatitis, a condition similar to atopic hand eczema. In clinical trials, Tralokinumab improved symptoms like itching and sleep problems as early as the first week of treatment. Many patients maintained these improvements for up to a year. Compared to a placebo, Tralokinumab was more effective, even when used with minimal amounts of other treatments like topical corticosteroids. This suggests that Tralokinumab could be a promising option for managing atopic hand eczema as well.12367
Do I need to stop my current medications to join the trial?Yes, you may need to stop certain medications. You cannot use systemic immunosuppressive drugs, systemic corticosteroids, or certain topical treatments like corticosteroids and calcineurin inhibitors within specific periods before starting the trial.
Eligibility 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
I have been diagnosed with atopic dermatitis.
My skin condition affects at least one body part besides my hands and wrists.
My hand eczema has lasted over 3 months or returned twice in the last year despite avoiding irritants.
I am 18 years old or older.
I have had Alzheimer's disease for at least 1 year.
Exclusion Criteria
My hand eczema is not caused by allergies, irritants, or other skin conditions.
Treatment Details
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 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.
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.
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.
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.
Review of Tralokinumab in the Treatment of Atopic Dermatitis. [2023]To review pharmacokinetics, efficacy, and safety of tralokinumab in treatment of atopic dermatitis (AD).
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 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 Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials. [2023]Two phase III trials, ECZTRA 1 and 2, confirmed the efficacy and safety of tralokinumab versus placebo in adults with moderate-to-severe atopic dermatitis (AD). To further explore the long-term efficacy of tralokinumab for AD, a pooled analysis of these trials was conducted.