402 Participants Needed

Tralokinumab for Atopic Hand Eczema

(ADHAND Trial)

Recruiting at 66 trial locations
CD
Overseen ByClinical Disclosure
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

Is 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.12367

How 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.12345

Research Team

ME

Medical Expert

Principal Investigator

LEO Pharma

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

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.
See 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.
See 2 more

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)

Treatment Details

Interventions

  • Tralokinumab
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

LEO Pharma

Lead Sponsor

Trials
275
Recruited
189,000+
Christophe Bourdon profile image

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug profile image

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD

Findings from Research

Tralokinumab is an effective treatment for adults with moderate to severe atopic dermatitis, showing significant improvements in symptoms and quality of life in pivotal phase III trials involving subcutaneous administration over 16 weeks.
The treatment was well tolerated, with most adverse events being mild to moderate, and it provided consistent symptom control for up to 2 years, indicating its long-term efficacy and safety.
Tralokinumab in Atopic Dermatitis: A Profile of Its Use.Blair, HA.[2022]
Tralokinumab is a new systemic therapy that effectively inhibits interleukin-13, showing promise in treating moderate-to-severe atopic dermatitis (AD) in adults, as supported by clinical trials.
It has been approved by Health Canada and the US FDA for use alone or in combination with topical corticosteroids, indicating its potential as a safe and effective treatment option for patients with limited existing therapies.
Tralokinumab for Moderate-to-Severe Atopic Dermatitis in Adults.Abduelmula, A., Rankin, BD., Mufti, A., et al.[2023]
Tralokinumab is a monoclonal antibody that effectively targets and neutralizes IL-13, a key cytokine involved in the development of atopic dermatitis, thereby inhibiting its harmful effects.
Based on the results from the ECZTRA 1-3 trials, tralokinumab has been approved in the EU for treating moderate-to-severe atopic dermatitis in adults, marking a significant advancement in systemic therapy options for this condition.
Tralokinumab: First Approval.Duggan, S.[2022]

References

Tralokinumab in Atopic Dermatitis: A Profile of Its Use. [2022]
Tralokinumab for Moderate-to-Severe Atopic Dermatitis in Adults. [2023]
Tralokinumab: First Approval. [2022]
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 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]
Review of Tralokinumab in the Treatment of Atopic Dermatitis. [2023]
New Drug for Atopic Dermatitis. [2023]