Tralokinumab for Atopic Hand Eczema

(ADHAND Trial)

Recruiting at 80 trial locations

Overseen By Clinical Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: LEO Pharma

Must not be taking: Immunosuppressives, Corticosteroids, Biologics, others

Disqualifiers: Contact dermatitis, Phototherapy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

235 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tralokinumab (also known as Adbry or Adtralza) is safe and effective for treating moderate-to-severe atopic hand eczema, a condition that causes itchy and inflamed skin on the hands. Participants will receive either tralokinumab or a placebo (a dummy treatment) for the first 16 weeks, followed by tralokinumab for another 16 weeks. The trial seeks individuals who have had atopic hand eczema for more than three months or have experienced multiple recurrences in the past year and have tried other prescription treatments without success. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that tralokinumab is likely to be safe for humans?

Research shows that tralokinumab is generally safe for people. Previous studies on atopic dermatitis (a type of eczema) indicate that most people tolerate the treatment well. Common side effects are mild and may include reactions at the injection site or symptoms similar to a cold. Importantly, no serious side effects have been commonly reported.

The FDA has approved tralokinumab for another type of eczema, suggesting its safety for similar conditions. This approval means it has been tested and found safe for related cases. However, individual reactions can vary. Always consult a healthcare provider about potential risks before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for atopic hand eczema, such as topical steroids and calcineurin inhibitors, focus on reducing inflammation but often come with side effects like skin thinning or irritation. Tralokinumab is unique because it specifically targets and neutralizes IL-13, a key cytokine involved in the inflammatory process of eczema. This targeted approach not only reduces the potential for side effects associated with broader immune suppression but also offers a novel method of controlling eczema symptoms. Researchers are excited because tralokinumab's precision could lead to more effective and safer long-term management of atopic hand eczema.

What evidence suggests that tralokinumab might be an effective treatment for atopic hand eczema?

Research has shown that tralokinumab effectively treats conditions like atopic dermatitis, which resembles atopic hand eczema. In this trial, participants will receive either tralokinumab or a placebo for the first 16 weeks. One study found that tralokinumab significantly improved hand eczema symptoms compared to a placebo. Patients experienced a decrease in the severity and size of their eczema, with noticeable relief from itching. Another report indicated that tralokinumab can reduce itching within 48 hours and maintain these benefits for up to three years. These findings suggest that tralokinumab could be a promising option for managing moderate-to-severe atopic hand eczema. ^{2 3 5 6 7}

Who Is on the Research Team?

Medical Expert

Principal Investigator

LEO Pharma

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Tralokinumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Tralokinumab Experimental Treatment 1 Intervention

Tralokinumab is administered for 32 weeks (16 weeks double-blinded period + 16 weeks open-label period)

Group II: Placebo + tralokinumab Placebo Group 1 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

Who Is Running the Clinical Trial?

LEO Pharma

Lead Sponsor

Trials

275

Recruited

189,000+

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD

Published Research Related to This Trial

Tralokinumab, a monoclonal antibody targeting interleukin-13, was found to be well tolerated in a pooled analysis of 2285 patients with moderate-to-severe atopic dermatitis, showing similar rates of adverse events compared to placebo over treatment periods of up to 52 weeks.

While some common adverse events like respiratory infections and conjunctivitis occurred more frequently with tralokinumab, serious adverse events were less common compared to placebo, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Simpson, EL., Merola, JF., Silverberg, JI., et al.[2023]

Tralokinumab-ldrm (Adbry) is an approved treatment for moderate to severe atopic dermatitis in adults who do not respond to topical therapies, highlighting its efficacy in managing this skin condition.

Patients need to be educated on the proper subcutaneous administration of Tralokinumab, including the requirement for multiple injections to achieve the full prescribed dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug for Atopic Dermatitis. Aschenbrenner, DS.[2023]

Tralokinumab has been shown to be effective in treating moderate-to-severe atopic dermatitis (AD), with significant improvements in the Investigator's Global Assessment (IGA) scores in phase 2 and phase 3 trials involving multiple subjects, demonstrating its efficacy both as a standalone treatment and in combination with topical corticosteroids.

Tralokinumab is considered a safe systemic treatment option for AD, lacking the black-box warnings associated with some other treatments, making it a favorable choice for patients, especially those who cannot use oral cyclosporine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Tralokinumab in the Treatment of Atopic Dermatitis. Singh, R., Taylor, A., Shah, MA., et al.[2023]

In two phase III trials involving adults with moderate-to-severe atopic dermatitis, tralokinumab monotherapy significantly outperformed placebo, with more patients achieving an Investigator's Global Assessment score of 0 or 1 and a 75% improvement in eczema severity by week 16.

Tralokinumab was well tolerated over 52 weeks, with a similar rate of adverse events compared to placebo, indicating its safety as a long-term treatment option for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Wollenberg, A., Blauvelt, A., Guttman-Yassky, E., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tralokinumab in Atopic Dermatitis: A Profile of Its Use. Blair, HA.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tralokinumab: First Approval. Duggan, S.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tralokinumab for Moderate-to-Severe Atopic Dermatitis in Adults. Abduelmula, A., Rankin, BD., Mufti, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12033154/

Long-Term Efficacy and Potential Predictors of ... Based on our results, tralokinumab appears to be a safe and effective therapeutic option for patients > 65 years old with moderate-to-severe AD, ...

2. adbryhcp.com adbryhcp.com/efficacy-results/adult

Adbry® for Adults: Efficacy & Long-Term Control Itch reduction was observed with Adbry at 48 hours, 16 weeks, and up to 3 years · WEEK 1 RESULTS · WEEK 16 RESULTS · 3 YEAR RESULTS ...

3. medicaljournalssweden.se medicaljournalssweden.se/actadv/article/view/42275/49592

Effectiveness and Safety of Tralokinumab in Atopic Dermatitis Primary outcomes included 50%, 75%, and 90% improvement in Eczema Area and Severity Index score (EASI50, EASI75, EASI90, respectively) and ...

4. dermatologytimes.com dermatologytimes.com/view/tralokinumab-shows-hand-relief-in-adhand-trial

Tralokinumab Shows Hand Relief in ADHAND Trial Tralokinumab met all primary and secondary endpoints, showing significant improvements in atopic dermatitis on the hands compared to placebo.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05958407

Study Details | NCT05958407 | A 32-week Trial to Evaluate ... The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40077977/?utm_source=SimplePie&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1DqqIY7i9Icf9J_BIwh0PRg_lq4ZdpZVa2NCCBt_Z5SBUCUY-a&fc=20220524054013&ff=20250313114748&v=2.18.0.post9+e462414

Effectiveness and Safety of Tralokinumab in Atopic Dermatitis Primary outcomes included 50%, 75%, and 90% improvement in Eczema Area and Severity Index score (EASI50, EASI75, EASI90, respectively) and ...

7. thedermdigest.com thedermdigest.com/tralokinumab-adbry-leo-pharma-shows-efficacy-and-safety-in-moderate-to-severe-hand-ad/

Tralokinumab (Adbry, Leo Pharma) Shows Efficacy and ... The trial met the primary endpoint and all secondary endpoints, demonstrating a statistically significant improvement in atopic dermatitis on the hands after 16 ...