Tralokinumab + Topical Corticosteroids for Eczema
(TRAPEDS 2 Trial)
Recruiting in Palo Alto (17 mi)
+45 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: Immunosuppressants, Corticosteroids, Calcineurin inhibitors, others
Disqualifiers: Active infections, Hepatitis B or C, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.
The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.
The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.
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.
What data supports the effectiveness of the drug Tralokinumab + Topical Corticosteroids for eczema?
The research shows that topical corticosteroids are effective in treating skin conditions like psoriasis and eczema, as they help reduce inflammation and heal the skin. While the studies focus on psoriasis, the effectiveness of corticosteroids in reducing skin inflammation suggests they may also be beneficial when used with Tralokinumab for eczema.
12345Is Tralokinumab + Topical Corticosteroids safe for treating eczema?
Topical corticosteroids are generally safe for treating eczema, but a small number of people may develop a contact allergy to them. This is uncommon, but if eczema worsens or doesn't improve, an allergy test might be needed.
678910How does the drug Tralokinumab differ from other eczema treatments?
Tralokinumab is unique because it targets and blocks a specific protein called interleukin-13 (IL-13), which plays a key role in the inflammation associated with eczema, unlike traditional treatments that often use topical corticosteroids. This approach may reduce the risk of side effects commonly associated with long-term steroid use.
37111213Eligibility Criteria
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.
+6 more
Trial Timeline
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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: Tralokinumab + TCS for subjects aged 6 months to <2 yearsExperimental Treatment1 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 yearsExperimental Treatment1 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 yearsExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Leo Pharma Investigational siteBirmingham, AL
Leo Pharma Investigational siteNorth Little Rock, AR
Leo Pharma Investigational siteWaterford, MI
Leo Pharma Investigational siteTulsa, OK
More Trial Locations
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Who Is Running the Clinical Trial?
LEO PharmaLead Sponsor
References
Medical adherence to topical corticosteroid preparations prescribed for psoriasis: A systematic review. [2018]Topical corticosteroids and corticosteroid combinations are the principal treatments in psoriasis. The aim of this study was to investigate published literature dealing with medical adherence to topical corticosteroid or corticosteroid combinations in patients with psoriasis.
Non steroid treatment for eczema: results from a controlled and randomized study. [2015]This study assesses the efficacy of a new non steroid anti-inflammatory product in comparison to Hydrocortisone Butyrate 0.1% Cream in healing eczematous dermatitis.
Treatment of psoriasis and other dermatoses with a single application of a corticosteroid left under a hydrocolloid occlusive dressing for one week. [2004]Lotions of five different corticosteroids were applied on 3 X 4 cm areas of large infiltrated chronic psoriatic plaque in eight patients, and left occluded with a hydrocolloid dressing (Actiderm) for one week. Area treated with clobetasol, betamethasone and triamcinolone were clinically healed within one week in four patients, but slight residual erythema was observed in the other four. Hydrocortisone-treated areas showed better improvement than the non-steroid-treated control area, where infiltration and erythema remained unchanged. In 44 patients with psoriasis, lichen planus, chronic lichenified eczema, discoid lupus erythematosus and necrobiosis lipoidica, treatment with betamethasone applied 1-3 times under Actiderm once a week healed the lesions. The skin-coloured Actiderm is easy to apply and wear and does not loosen when taking a shower or hot bath.
Therapeutic response to a dermatologic patch and betamethasone valerate 0.1 percent cream in the management of chronic plaques in psoriasis. [2013]The efficacy of a hydrocolloid dermatologic patch (Actiderm) in conjunction with topical beta-methasone valerate 0.1 percent cream was studied in outpatients with chronic plaque-type psoriasis treated for three weeks, and observed for an additional two weeks after therapy. A significant degree (p less than 0.05) of lesion resolution occurred at the site treated with the dermatologic patch plus steroid cream, whereas sites treated with either agent alone showed mild but insignificant change. It was concluded that the patch was a highly effective adjunct in the treatment of chronic plaques of psoriasis.
Corticosteroid phobia (corticophobia) in parents of young children with atopic dermatitis and their health care providers. [2019]Adherence to topical corticosteroids is low among atopic dermatitis patients and their parents. This can lead to treatment failure and decreased quality of life.
Safety of topical corticosteroids in atopic eczema: an umbrella review. [2023]An umbrella review summarising all safety data from systematic reviews of topical corticosteroids (TCS) in adults and children with atopic eczema.
[Contact allergy to local steroids. Contact allergy to corticosteroids among consecutively tested patients with eczema]. [2006]We studied the frequency of contact dermatitis to corticosteroids in consecutive eczema patients and the relevance of positive patch test reactions. Of 2,742 patients patch tested at the Dermatology Clinic at Odense University Hospital between June 1991 and December 1995, 65 patients (47 women and 18 men) or 2.4% had a positive reaction to one or more of the corticosteroids tested. Forty (1.45%) had a positive reaction to budesonide 1% pet. in the standard series. For a one-year period 662 consecutive eczema patients were routinely patch tested with a corticosteroid series consisting of five steroid allergens, and 17 had a positive reaction to at least one of these (2.6%). Budesonide allergy was most often encountered, followed by hydrocortisone, tixocortol pivalate and hydrocortisone-17-butyrate. Betamethasone valerate, triamcinolone acetonide and clobetasol propionate rarely caused contact allergy. The corticosteroid allergy was of current relevance in about one third of the cases. Corticosteroid contact allergy is an uncommon adverse effect, in relation to the number of patients with inflammatory skin diseases who are treated with topical corticosteroids. In patients with longstanding eczematous skin disease, who do not improve or deteriorate during topical corticosteroid therapy, contact allergy to these drugs should be suspected and relevant patch tests should be performed to sort out concomitant reactions. Future treatment with corticosteroids must take into account possible cross-reactions.
Methotrexate vs. ciclosporin in the treatment of severe atopic dermatitis in children: a critical appraisal. [2022]El-Khalawany et al. (Eur J Pediatr 2012; 172: 351-6) aimed to compare the efficacy and safety of methotrexate vs. ciclosporin in the treatment of children with severe atopic eczema.
Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. [2022]In two randomized, double-blind, multicenter studies, a total of 631 adult patients with moderate to severe atopic dermatitis applied tacrolimus ointment (0.03% or 0.1%) or vehicle twice daily for up to 12 weeks. The mean percent body surface area (%BSA) affected at baseline was 45%, and 56% of patients had severe atopic dermatitis. As previously reported, these studies showed that tacrolimus ointment was superior to vehicle for all efficacy parameters measured. This report focuses on the safety of tacrolimus ointment in these studies. The most common adverse events were the sensation of skin burning, pruritus, flu-like symptoms, skin erythema, and headache. Skin burning and pruritus were more common among patients with severe or extensive disease; these events were usually brief and were resolved during the first few days of treatment. Common adverse events with a significantly higher incidence in one or both of the tacrolimus ointment groups than in the vehicle group included skin burning, flu-like symptoms, and headache. More patients in the vehicle group discontinued the study because of an adverse event than in either of the tacrolimus ointment groups. There were no notable or consistent changes in any laboratory variables. Tacrolimus was not detected in 80% of blood samples collected. Measurable concentrations of tacrolimus were transitory and were not associated with adverse events. Tacrolimus ointment is a safe therapy for the treatment of adult patients with atopic dermatitis on the face, neck, or other body regions.
The efficacy and safety of tacrolimus ointment: a clinical review. [2013]Topical tacrolimus ointment was approved for the treatment of atopic dermatitis in Japan in 1999, the United States in 2000, and Europe in 2001. The safety and efficacy of tacrolimus ointment was established in vehicle-controlled, randomized, 12-week clinical trials; 1-year open-label trials; and comparative studies with topical steroids. Although an extensive database exists on the safety and efficacy of tacrolimus ointment based on the global development program, clinicians desire additional information on the long-term safety and efficacy of this novel agent. In this supplement, additional studies are reported that extend the safety and efficacy profile of tacrolimus ointment in patients with atopic dermatitis, including long-term safety studies for up to 4 years. The studies presented in this supplement address important questions regarding the selection and use of tacrolimus ointment in the treatment of patients with atopic dermatitis.
[Urea in combination with corticosteroids in treating eczema]. [2015]Tar distillates and topical corticosteroids are still being used to treat chronic eczema. With the use of halogenised corticosteroids local and systemic side-effects are increasing. There fore this both doctor and patient often reject treatment. To avoid this a local treatment with corticosteroids should be effective without having side-effects. In a double-blind investigation we compared a new preparation of 1% hydrocortisone plus 10% urea with hydrocortisone 17-valerate in the treatment of atopic dermatitis. There was no difference between the two preparations concerning the improvement of symptoms and the course of the disease. However, as opposed to the monopreparation, the combination of hydrocortisone and urea caused no side-effects.
Off-Label studies on anakinra in dermatology: a review. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">Anakinra (Kineret®) is an interleukin-1 receptor antagonist (IL-1Ra) FDA approved for use in rheumatoid arthritis and in neonatal-onset multisystem inflammatory disease (NOMID). It has been used off-label for a variety of dermatologic conditions. A review of the available studies and cases of these off-label uses would be valuable to the dermatologist considering alternative treatments for these oftentimes poorly studied conditions.
Topical tacrolimus for atopic dermatitis. [2023]Atopic dermatitis (AD) (or atopic eczema) is a chronic inflammatory skin condition that affects children and adults and has an important impact on quality of life. Topical corticosteroids (TCS) are the first-line therapy for this condition; however, they can be associated with significant adverse effects when used chronically. Tacrolimus ointment (in its 2 manufactured strengths of 0.1% and 0.03%) might be an alternative treatment. Tacrolimus, together with pimecrolimus, are drugs called topical calcineurin inhibitors (TCIs).