Tralokinumab for Atopic Dermatitis

(INJECZTRA Trial)

No longer recruiting at 30 trial locations

Overseen By Clinical Disclosure

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: LEO Pharma

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

Disqualifiers: Active skin infections, Tuberculosis, 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: Unknown

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called tralokinumab, an injectable medication administered through an autoinjector, to determine its effectiveness for moderate to severe atopic dermatitis (a type of eczema). The trial aims to assess both the treatment's efficacy and safety. Participants will begin with a 600 mg dose, followed by 300 mg every other week for 14 weeks. This trial may suit individuals aged 12 and older who have had atopic dermatitis for at least a year and have not found success with topical treatments. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting. You must not use systemic immunosuppressive drugs, systemic corticosteroids, or certain topical treatments for a specified period before the trial begins.

Is there any evidence suggesting that tralokinumab administered by autoinjector is likely to be safe?

Research has shown that tralokinumab, administered as an injection under the skin, is generally safe and well-tolerated. Studies lasting up to 52 weeks produced results consistent with earlier findings, indicating a positive safety profile. However, some serious side effects, such as allergic reactions, including a severe one called anaphylaxis, have been reported. Participants should be aware of these potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for atopic dermatitis?

Tralokinumab is unique because it targets the IL-13 cytokine, a key player in the inflammation seen in atopic dermatitis. Unlike standard treatments like topical corticosteroids or calcineurin inhibitors, tralokinumab is administered via an autoinjector, which could make it more convenient for patients to use at home. Researchers are particularly excited because this method of delivery might improve compliance and patient comfort, potentially leading to better management of moderate to severe atopic dermatitis.

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

Research has shown that tralokinumab helps treat moderate to severe atopic dermatitis (AD), a type of eczema. Patients using tralokinumab have experienced skin improvement over time, with benefits lasting up to a year. Itch relief can begin as soon as 48 hours after starting treatment and continues to improve by week 16, with effects lasting up to three years. Although tralokinumab may not be as effective as some other treatments, it still provides significant relief for many individuals. Overall, tralokinumab is a reliable option for managing AD symptoms over the long term. ^{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?

Inclusion Criteria

Age 12 years and above

Subject able and willing to self-administer tralokinumab with Device A

A recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medication or for whom topical treatments are otherwise medically inadvisable

Exclusion Criteria

Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment

Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to baseline

Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to baseline

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an initial SC dose of 600 mg tralokinumab at baseline, followed by 300 mg every other week for 14 weeks

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tralokinumab

How Is the Trial Designed?

Group I: Tralokinumab subcutaneous dosing by an autoinjector Experimental Treatment 1 Intervention

An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.

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

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK608444/

Pharmacoeconomic Review - Tralokinumab (Adtralza) - NCBI These findings align with the available indirect clinical evidence suggesting that tralokinumab is less effective than dupilumab at 16 weeks. The key drivers of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05194540

NCT05194540 | Efficacy and Safety of Tralokinumab ... The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0190962225001318

Real-world experience of tralokinumab for atopic dermatitis In a subgroup analysis, effectiveness outcomes were numerically lower for patients utilizing tralokinumab monotherapy (exclusion of concomitant treatments) ...

4. 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37682422/

Tralokinumab Efficacy Over 1 Year in Adults with Moderate ... Conclusions: Tralokinumab treatment provides progressive and sustained improvement over 1 year in the extent and severity of AD in patients with ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761180s006lbl.pdf

ADBRY® (tralokinumab-ldrm) injection, for subcutaneous use The safety profile of ADBRY in these subjects, assessed through the initial treatment period of 16 weeks and the long-term period of 52 weeks, was comparable to ...

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

Adbry® Side Effects & Safety | What to Know Before Starting ADBRY can cause serious side effects, including: Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis.

8. mayoclinic.org mayoclinic.org/drugs-supplements/tralokinumab-ldrm-subcutaneous-route/description/drg-20528296

Tralokinumab-ldrm (subcutaneous route) - Side effects & ... Dosing · Adults—At first, 600 milligrams (mg) (two 300 mg injections) injected under the skin at different injection sites. · Children 12 to 17 ...

9. ema.europa.eu ema.europa.eu/en/documents/product-information/adtralza-epar-product-information_en.pdf

Adtralza, INN-tralokinumab - European Medicines Agency There is no specific treatment for tralokinumab overdose. In clinical studies with tralokinumab, single intravenous doses of up to 30 mg/kg and ...

10. medcentral.com medcentral.com/drugs/monograph/183293-322008/tralokinumab-ldrm-subcutaneous

Tralokinumab-ldrm: uses, dosing, warnings, adverse ... Results revealed that tralokinumab-ldrm 300 mg as an initial dose followed by 150 mg every other week was associated with a substantial increase in patients ...