Tralokinumab + Topical Corticosteroids for Eczema

(TRAPEDS 2 Trial)

Recruiting at 68 trial locations

Overseen By Clinical Disclosure

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: LEO Pharma

Must not be taking: Immunosuppressants, Corticosteroids, Calcineurin inhibitors, others

Disqualifiers: Active infections, Hepatitis B or C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 2

Duration: 196 weeks

195 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment combining tralokinumab (an injectable medication) with topical corticosteroids (skin creams) is safe and effective for moderate-to-severe eczema in young children and infants. The study will compare the effectiveness of this treatment against a placebo (a non-active treatment) combined with skin creams for children, while infants will receive only the active treatment. Children and infants who have had eczema for 3 to 12 months and have not responded well to standard creams might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants early access to a potentially effective treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop certain medications before joining the trial. Specifically, you must stop using topical corticosteroids, calcineurin inhibitors, phosphodiesterase-4 inhibitors, and Janus kinase inhibitors at least 1 week before starting, and systemic immunosuppressive drugs and corticosteroids 4 weeks before starting.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tralokinumab has been studied for its safety in treating eczema, particularly in older children and adults. These studies indicate that tralokinumab has a similar safety profile in children aged 12 to 17 as in adults, with comparable types and frequencies of side effects.

One study found that tralokinumab might reduce rates of skin inflammation and asthma compared to a placebo. Some known side effects include eye problems, though these are less common.

While this trial focuses on younger children and infants, it builds on previous safety findings in older age groups. The advanced stage of this trial suggests that tralokinumab has been well-tolerated so far, which is promising for its use in younger children and infants. However, monitoring any new data from this trial remains important. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for eczema?

Researchers are excited about tralokinumab for eczema because it offers a fresh approach to managing this itchy and often frustrating condition. Unlike standard treatments that primarily rely on topical corticosteroids to reduce inflammation, tralokinumab is a monoclonal antibody that targets and neutralizes a specific protein involved in the inflammation process, called IL-13. This targeted mechanism may lead to more effective and longer-lasting relief with potentially fewer side effects. Additionally, tralokinumab's ability to address eczema in younger patients, including those as young as six months, could be a game-changer, offering a new option for families seeking alternatives to traditional therapies.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Research shows that tralokinumab, when combined with topical corticosteroids (TCS), effectively treats moderate-to-severe atopic dermatitis (AD). Studies have found that tralokinumab targets interleukin-13, a part of the immune system involved in AD. It is both effective and well-tolerated in teenagers. In trials, many patients experienced significant improvement in their eczema, with at least a 75% reduction in severity according to the Eczema Area and Severity Index (EASI). Another study found that some patients experienced up to a 90% reduction in eczema severity. This trial will evaluate tralokinumab combined with TCS in children and infants, aiming to determine its effectiveness in relieving symptoms of moderate-to-severe AD in these age groups. ^{6 7 8 9 10}

Who Is on the Research Team?

Medical Expert

Principal Investigator

LEO Pharma

Are You a Good Fit for This Trial?

This trial is for children and infants aged 6 months to under 12 years with moderate-to-severe atopic dermatitis (eczema) who haven't improved with mid-strength topical corticosteroids. They must weigh at least 9 kg, have had AD for a minimum of 3-12 months depending on age, and show significant itchiness or scratching.

Inclusion Criteria

My skin condition didn't improve after using a prescribed cream in the last 6 months.

My body weight is at least 9 kg.

I am between 6 months and 12 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Children receive tralokinumab + TCS or placebo + TCS for 16 weeks, then all receive tralokinumab + TCS; infants receive open-label tralokinumab + TCS

196 weeks

Visits every 2 weeks for the first year, then every 6 weeks; some visits by phone

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tralokinumab

Trial Overview

The trial tests if tralokinumab injections plus topical corticosteroids are more effective than placebo plus TCS in treating eczema. Children will be randomly assigned to treatments for the first 16 weeks; then all get tralokinumab + TCS. Infants receive only the actual drug from the start.

How Is the Trial Designed?

Group I: Tralokinumab + TCS for subjects aged 6 months to <2 years Experimental Treatment 1 Intervention

Dose and dosing frequency for each subject will depend on the subject's body weight.

Group II: Tralokinumab + TCS for subjects aged 2 to <12 years Experimental Treatment 1 Intervention

Dose and dosing frequency for each subject will depend on the subject's body weight.

Group III: Placebo + TCS for subjects aged 2 to <12 years Experimental Treatment 1 Intervention

Dose and dosing frequency for each subject will depend on the subject's body weight.

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

A double-blind study found that a new treatment combining 1% hydrocortisone with 10% urea was as effective as hydrocortisone 17-valerate in improving symptoms of atopic dermatitis in patients.

Importantly, the combination treatment with hydrocortisone and urea did not cause any side effects, making it a safer alternative to traditional corticosteroid treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Urea in combination with corticosteroids in treating eczema]. Drosner, M.[2015]

In a study of 2,742 eczema patients, only 2.4% had a positive patch test reaction to corticosteroids, indicating that contact dermatitis from these medications is relatively uncommon.

Budesonide was the most frequently identified allergen among corticosteroids, suggesting that while corticosteroid contact allergy is rare, it should be considered in patients with persistent eczema who do not respond to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contact allergy to local steroids. Contact allergy to corticosteroids among consecutively tested patients with eczema]. Vestergaard, L., Andersen, KE.[2006]

Topical corticosteroids (TCS) used for atopic eczema showed no significant increased risk of skin thinning in short-term studies, indicating they are generally safe for use in both adults and children.

While TCS may have a higher relative risk of skin thinning compared to topical calcineurin inhibitors, the overall long-term safety data is limited, suggesting that intermittent use of TCS is safe but requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. Axon, E., Chalmers, JR., Santer, M., et al.[2023]

In two studies involving 631 adults with moderate to severe atopic dermatitis, tacrolimus ointment (0.03% or 0.1%) was found to be effective, significantly outperforming the vehicle in all measured efficacy parameters over 12 weeks.

While some patients experienced mild adverse events like skin burning and pruritus, these were generally brief and resolved quickly; importantly, tacrolimus ointment was deemed safe, with no significant laboratory changes and low systemic absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. Soter, NA., Fleischer, AB., Webster, GF., et al.[2022]

Tacrolimus 0.1% ointment is more effective than low-potency corticosteroids and pimecrolimus 1% in treating moderate to severe atopic dermatitis, based on a systematic review of 20 studies involving 5885 participants.

Both formulations of tacrolimus (0.1% and 0.03%) appear to be safe, with no evidence of increased risk for malignancies or skin atrophy, and serious adverse events were rare and generally unrelated to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical tacrolimus for atopic dermatitis. Cury Martins, J., Martins, C., Aoki, V., et al.[2023]

In a randomized controlled trial involving 40 children with severe atopic eczema, both methotrexate and ciclosporin showed similar efficacy in reducing eczema severity after 12 weeks, with no significant difference in the SCORAD index scores (P = 0.93).

Both treatments were associated with minor adverse effects, indicating that they are relatively safe and well tolerated for managing severe atopic eczema in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methotrexate vs. ciclosporin in the treatment of severe atopic dermatitis in children: a critical appraisal. Tsakok, T., Flohr, C.[2022]

Topical tacrolimus ointment has been shown to be effective for treating atopic dermatitis, with its safety and efficacy established through various clinical trials lasting up to 12 weeks and comparative studies with topical steroids.

Long-term safety studies extending up to 4 years provide additional reassurance about the use of tacrolimus ointment, addressing clinicians' concerns regarding its prolonged use in patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tacrolimus ointment: a clinical review. Beck, LA.[2013]

A systematic review of 11 studies found that nonadherence to topical corticosteroids in psoriasis patients varied widely, with rates ranging from 8% to 88.3%, highlighting a significant challenge in treatment effectiveness.

The study identified 34 factors contributing to nonadherence and noted that a disease management program improved adherence, suggesting that targeted interventions could enhance treatment outcomes for psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical adherence to topical corticosteroid preparations prescribed for psoriasis: A systematic review. Svendsen, MT., Andersen, F., Hansen, J., et al.[2018]

In a pilot study involving Italian adults with eczema, the new non-steroid anti-inflammatory cream showed effectiveness in reducing eczema severity, with recovery rates of 58.3% in the non-steroid group compared to 91.7% in the Hydrocortisone group when following the treatment protocol closely.

While Hydrocortisone Butyrate 0.1% Cream was more effective overall, the non-steroid cream demonstrated significant clinical improvement at each assessment point, suggesting it could be a viable long-term treatment option for eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non steroid treatment for eczema: results from a controlled and randomized study. De Waure, C., Cadeddu, C., Venditti, A., et al.[2015]

In a study involving outpatients with chronic plaque-type psoriasis, the combination of a hydrocolloid dermatologic patch (Actiderm) and topical beta-methasone valerate cream led to significant lesion resolution after three weeks of treatment.

In contrast, using either the patch or the steroid cream alone resulted in only mild and insignificant improvements, highlighting the patch's effectiveness as an important addition to psoriasis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic response to a dermatologic patch and betamethasone valerate 0.1 percent cream in the management of chronic plaques in psoriasis. Wilkinson, RD., Ohayon, M.[2013]

Corticophobia, or fear of using topical corticosteroids, is prevalent among both parents of children with atopic dermatitis and health care professionals, with parents and public health care nurses scoring equally high at 44%.

The study found that general practitioners and pediatricians had lower corticophobia scores (39% and 31%, respectively), indicating that the type of profession and personal experience with atopic dermatitis significantly influence beliefs about corticosteroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid phobia (corticophobia) in parents of young children with atopic dermatitis and their health care providers. Bos, B., Antonescu, I., Osinga, H., et al.[2019]

Anakinra, an interleukin-1 receptor antagonist, shows promising efficacy for various dermatologic conditions, particularly hidradenitis suppurativa, Bechet's disease, Muckle-Wells syndrome, and SAPHO syndrome, based on a review of available studies and case reports.

With a relatively benign adverse effect profile, anakinra may be a valuable treatment option for patients with difficult-to-treat dermatologic diseases that do not respond to standard therapies, although more high-quality research is needed to better define its role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label studies on anakinra in dermatology: a review. Tegtmeyer, K., Atassi, G., Zhao, J., et al.[2022]

In a study involving eight patients with chronic psoriatic plaques, clobetasol, betamethasone, and triamcinolone were effective in healing lesions within one week when occluded with a hydrocolloid dressing, while hydrocortisone showed better results than the untreated control area.

In a larger group of 44 patients with various skin conditions, betamethasone applied weekly under the same dressing led to healing of lesions, demonstrating the efficacy of this treatment method for multiple dermatological issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of psoriasis and other dermatoses with a single application of a corticosteroid left under a hydrocolloid occlusive dressing for one week. Juhlin, L.[2004]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10116386/

Efficacy and Safety of Tralokinumab in Adolescents With ...

This trial showed that interleukin-13–targeted treatment with tralokinumab was efficacious and well tolerated in adolescents with moderate to severe atopic ...

2.

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 ...

3.

link.springer.com

link.springer.com/article/10.1007/s13555-025-01484-1

Clinically Meaningful Improvements in Adolescents with ...

Clinically meaningful responses were defined as either ≥50% improvement from baseline in Eczema Area and Severity Index (EASI-50), ≥3-point ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06311682

NCT06311682 | A Trial to Evaluate the Efficacy and Safety ...

Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening. The EASI is a validated measure ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40142885/

Effectiveness of Tralokinumab Across Atopic Dermatitis ...

By week 24, generalized lichenoid reached 100% EASI improvement, significantly outperforming other phenotypes. The highest EASI-75 rates were ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39193341/

Assessing the real-world safety of tralokinumab for atopic ...

This study has provided preliminary safety data on the real-world application of tralokinumab, confirming some known adverse reactions and revealing additional ...

7.

adbry.com

adbry.com/about-adbry/adbry-side-effects

Adbry® Side Effects & Safety | What to Know Before Starting

Safety of Adbry in children (ages 12-17) was similar to the safety data in adults with moderate-to-severe eczema . Safety was measured at 16 weeks and 52 weeks.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40879371/

Safety of tralokinumab in patients with moderate-to-severe ...

Dermatitis atopic and asthma occurred at lower rates with tralokinumab vs. placebo (IRR=0.51 and 0.57, respectively). AESI eye disorders ...

9.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1458438/full

Assessing the real-world safety of tralokinumab for atopic ...

This study has provided preliminary safety data on the real-world application of tralokinumab, confirming some known adverse reactions and revealing additional ...

10.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2023/761180s001lbl.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION

The safety of tralokinumab was assessed in a trial of 289 pediatric subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis (ECZTRA 6). The ...