Tralokinumab for Eczema

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Psoriasis Treatment Center of Central New Jersey

Must be taking: Dupilumab

Must not be taking: Systemic steroids, Cyclosporine

Disqualifiers: Tralokinumab exposure, Uncontrolled major disease, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Tralokinumab, an antibody therapy, for individuals with eczema, specifically atopic dermatitis, who have previously used Dupilumab. The goal is to evaluate Tralokinumab's effectiveness over 24 weeks for those who didn't fully respond to Dupilumab or experienced side effects. Suitable participants have used Dupilumab for at least 12 weeks and stopped due to insufficient effectiveness or adverse effects. As a Phase 4 trial, this research aims to understand how this FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using certain systemic therapies for atopic dermatitis, like systemic steroids or oral JAK inhibitors, at least 4 weeks before starting. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What is the safety track record for Tralokinumab?

Research has shown that tralokinumab is generally well-tolerated. In studies, participants using tralokinumab experienced fewer cases of skin inflammation and asthma compared to those receiving a placebo, with rates reduced by about half. Over 4.5 years of use, no new safety concerns have emerged, and the occurrence of unwanted effects has remained stable, suggesting that tralokinumab is safe for long-term use.

Some studies have also demonstrated that tralokinumab significantly improves eczema symptoms. For instance, many patients achieved a 75% or greater improvement in their Eczema Area and Severity Index scores. Although there are known side effects, these studies confirm that tralokinumab has a strong safety profile for treating atopic dermatitis, a type of eczema. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tralokinumab is unique because it targets a specific protein called IL-13, which plays a key role in the inflammation and itchiness associated with eczema. This is different from most current eczema treatments, like corticosteroids and calcineurin inhibitors, which broadly suppress the immune system. By focusing on IL-13, tralokinumab aims to reduce symptoms with potentially fewer side effects. Researchers are excited because this targeted approach could offer a more effective and safer long-term solution for eczema patients.

What is the effectiveness track record for Tralokinumab in treating eczema?

Research shows that tralokinumab, the treatment under study in this trial, effectively treats atopic dermatitis, commonly known as eczema. Studies have found that people using tralokinumab experienced significant improvements, with eczema symptoms reducing by 50%, 75%, and even 90%. Many continued to benefit even after 16 weeks of treatment. Additionally, tralokinumab has proven safe and effective for older adults with moderate-to-severe eczema. Overall, it offers a promising treatment option for those with this skin condition. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with atopic dermatitis previously treated with dupilumab but needing alternative therapy can join. They must be in good health, not pregnant or lactating, and willing to use contraception. Excluded are those recently on systemic eczema therapies, non-compliant with Dupixent, using tanning/phototherapy, or have uncontrolled diseases.

Inclusion Criteria

I am not pregnant and will use birth control if there's a risk of getting pregnant.

I have been treated with dupilumab for my skin condition.

I am eligible for treatment that affects my whole body.

Exclusion Criteria

Patient non-compliant with Dupixent dosing based on investigator discretion

I haven't used any systemic treatments for eczema in the last 4 weeks.

I haven't used tanning beds or undergone phototherapy in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tralokinumab 600mg at week 0 followed by 300mg every 2 weeks for 24 weeks

24 weeks

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 Tralokinumab as an alternative for atopic dermatitis patients who didn't respond well to Dupilumab. Participants receive a starting dose of 600mg followed by 300mg every two weeks for six months to evaluate its effectiveness and safety.

How Is the Trial Designed?

Group I: Tralokinumab Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Psoriasis Treatment Center of Central New Jersey

Lead Sponsor

Trials

18

Recruited

530+

LEO Pharma

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

Tralokinumab Efficacy Over 1 Year in Adults with Moderate ... These results demonstrate that many tralokinumab-treated patients continue to improve beyond Week 16, and highlight that efficacy results at ...

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. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/all.16414

Tralokinumab Treatment in Adult Atopic Dermatitis Patients ... All primary outcomes significantly improved during 28 weeks of tralokinumab treatment and the probability of achieving EASI ≤ 7 and NRS-pruritis ...

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

Real-world experience of tralokinumab for atopic dermatitis While its efficacy and safety have been demonstrated in clinical trials, real-world data remain limited., Herein, we provide evidence regarding tralokinumab use ...

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2808887

Safety and Efficacy of Tralokinumab in Older Adults With ... The results of this post hoc analysis suggest that tralokinumab is well tolerated and efficacious in patients 65 years or older with moderate-to-severe AD.

6. 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 ...

7. academic.oup.com academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljaf309/8243959

Safety of tralokinumab in patients with moderate-to-severe ... No new safety signals were observed through 4.5 years of tralokinumab treatment, and the rates of adverse events and adverse events of special ...

8. 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 ...