Lutikizumab for Eczema

(EMBARK Trial)

Recruiting at 34 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: Biologics, Systemic JAK inhibitors

Disqualifiers: Phototherapy, Herbal treatments, 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

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the effectiveness and safety of lutikizumab for treating moderate to severe eczema (also known as atopic dermatitis, a skin condition causing itchy rashes). Participants will receive regular injections of either lutikizumab or a placebo for a period, followed by lutikizumab for the remainder of the trial. The trial may require more frequent doctor visits and tests than usual eczema treatments. It is suitable for individuals with eczema symptoms persisting for over a year who have not improved with common topical treatments or have medical reasons to avoid them. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications before joining the trial. There are specific 'washout' periods (time without taking certain medications) for various treatments, such as systemic therapies, biologics, and topical treatments, ranging from 7 days to 16 weeks, depending on the medication.

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

Research has shown that lutikizumab has been tested in earlier studies for conditions like hidradenitis suppurativa, a skin disorder. In those studies, lutikizumab was generally well-tolerated. Patients who received doses similar to those planned for the eczema trial experienced better skin conditions and reported fewer side effects. Most side effects were mild, such as headaches or irritation at the injection site. However, some participants experienced more serious reactions, though these were less common.

Since this trial is in Phase 2, lutikizumab has already undergone initial safety testing in humans. This phase focuses on further evaluating the treatment's safety and effectiveness for eczema. If lutikizumab is approved for another condition, it suggests the treatment might be safe, but each condition can respond differently.

Participants should consider these findings and discuss any concerns with their healthcare provider before joining the trial. ^{1 2 3 4 5}

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

Researchers are excited about lutikizumab for eczema because it works differently from most current treatments, which typically involve topical corticosteroids or immunosuppressants. Lutikizumab is unique because it targets specific inflammatory proteins called interleukins, which play a key role in eczema flare-ups. This targeted approach could potentially reduce inflammation more effectively and with fewer side effects compared to broader-acting treatments. Additionally, lutikizumab's dosing schedule, with different doses over a period of time, offers a structured progression that might optimize its effectiveness and patient outcomes over the long term.

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

Research has shown that lutikizumab might help with skin conditions like eczema by reducing inflammation. In a study involving individuals with hidradenitis suppurativa, a condition similar to eczema, lutikizumab significantly reduced symptoms. This finding suggests it could also benefit those with moderate to severe eczema. In this trial, participants will receive either lutikizumab monotherapy or a placebo followed by lutikizumab. The primary aim of such studies is often to reduce skin problems by at least 75%, indicating the treatment's effectiveness. While more research is needed specifically for eczema, these results offer promise for those seeking new treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe atopic dermatitis (AD) that started at least a year ago. Participants should have tried and not responded well to standard AD treatments like topical steroids or systemic therapies, or cannot use them due to side effects.

Inclusion Criteria

I have been diagnosed with atopic dermatitis for over a year.

I've used a simple moisturizer twice a day for at least a week.

My skin condition didn't improve with creams or pills, or I can't use them due to side effects.

Exclusion Criteria

I haven't used any skin treatments except basic moisturizers in the last week.

I haven't taken any systemic therapy for my condition within the last 4 weeks or 5 half-lives, whichever is longer.

I haven't taken any biologic treatments recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive subcutaneous injections of lutikizumab or placebo every other week

16 weeks

Regular visits at a hospital or clinic

Treatment Period 2

Participants receive subcutaneous injections of lutikizumab every other week

32 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lutikizumab

Trial Overview The study tests the effectiveness of Lutikizumab, an investigational medication, compared to a placebo in treating AD. It involves initial treatment followed by extended therapy over a total of 52 weeks with regular hospital or clinic visits.

How Is the Trial Designed?

Group I: Sub-Study 1: Placebo to Lutikizumab Experimental Treatment 2 Interventions

In Period 1, participants will be receive a matching placebo Dose A at Baseline randomization, followed by matching placebo Dose B every other week starting at Week 2 for 16 weeks. At Week 16, participants that were assigned placebo will then enter Period 2 and receive open-label lutikizumab Dose A , followed by lutikizumab Dose B every other week starting at Week 18, and lutikizumab Dose C every other week starting at Week 32 until Week 52.

Group II: Sub-Study 1: Lutikizumab Monotherapy Experimental Treatment 1 Intervention

In Period 1, participants will be receive lutikizumab Dose A at Baseline randomization, followed by Dose B every other week starting at Week 2 for 16 weeks. participants will continue into Period 2 at Week 16 with Dose C every other week until Week 52.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a study of 60 patients with atopic dermatitis treated with dupilumab, serum TARC and LDH levels were strongly associated with changes in disease activity, indicating their potential as effective markers for monitoring treatment response.

The study highlights that the relevance of laboratory markers, such as IgE and eosinophil counts, varies depending on the treatment used, suggesting that dupilumab alters the relationship between these markers and disease activity compared to untreated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association study of transition of laboratory marker levels and transition of disease activity of atopic dermatitis patients treated with dupilumab. Mizuno, M., Horiguchi, G., Teramukai, S., et al.[2022]

In a phase 3 trial involving 211 patients with moderate-to-severe atopic dermatitis, lebrikizumab (LEB) combined with topical corticosteroids (TCS) significantly improved skin condition, with 41.2% of patients achieving a clear or almost clear skin score compared to 22.1% in the placebo group.

The safety profile of LEB was consistent with previous studies, with most adverse events being mild or moderate, and serious adverse events were similarly low in both the LEB and placebo groups, indicating that LEB is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). Simpson, EL., Gooderham, M., Wollenberg, A., et al.[2023]

Lebrikizumab, an interleukin 13 monoclonal antibody inhibitor, shows promising efficacy in treating atopic dermatitis, with rapid improvement in itching observed as early as 2 days after treatment.

The treatment is well tolerated and has an acceptable safety profile, with lower reported risks of infection compared to another treatment, dupilumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Atopic Dermatitis with Lebrikizumab - The Evidence to Date. Labib, A., Ju, T., Yosipovitch, G.[2022]

Dupilumab is a monoclonal antibody that specifically targets the IL-4Rα subunit of IL-4 and IL-13 receptors, effectively blocking the signaling pathways of these cytokines involved in type 2 inflammation.

Approved in March 2017 for atopic dermatitis, dupilumab offers a targeted treatment option for eczema by reducing the inflammatory response associated with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL-4Rα Inhibitor for Atopic Disease. Chang, HY., Nadeau, KC.[2019]

Lebrikizumab, an IL-13 inhibitor, showed significant efficacy in treating moderate-to-severe atopic dermatitis, with 60.6% of patients achieving a 75% improvement in eczema severity after 16 weeks, compared to only 24.3% in the placebo group.

Both lebrikizumab and tralokinumab demonstrated good safety profiles, with low rates of conjunctivitis (1.4%-3.8% for lebrikizumab) and comparable adverse events to placebo, suggesting they are promising alternatives to dupilumab for patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of IL-13: A New Pathway for Atopic Dermatitis [Formula: see text]. Ratnarajah, K., Le, M., Muntyanu, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06718101

NCT06718101 | A Study to Evaluate the Effectiveness and ... The purpose of this study is to evaluate the clinical efficacy and safety of single therapies and/or combination therapies for moderate to severe AD through ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/560036

A Study to Evaluate the Effectiveness and Safety of ... Primary outcome measures · Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12436573/

Efficacy and Safety of Lebrikizumab in Adult and Adolescent ... This open-label, phase IIIb study is the first to assess the efficacy and safety of lebrikizumab for moderate-to-severe atopic dermatitis ...

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-922

A Study to Assess Molecular Changes in Adult Participants ... A study to assess molecular changes in adult participants with moderate to severe hidradenitis Suppurativa or with moderate to severe atopic dermatitis ...

5. news.abbvie.com news.abbvie.com/2024-01-08-Lutikizumab-Showed-Positive-Results-in-a-Phase-2-Trial-of-Adults-with-Moderate-to-Severe-Hidradenitis-Suppurativa-as-Program-Advances-to-Phase-3

Lutikizumab Showed Positive Results in a Phase 2 Trial of ... The study's primary endpoint was an achievement of HiSCR 50 at week 16, and the secondary endpoint was skin pain NRS30 at week 16 among subjects ...

6. go.drugbank.com go.drugbank.com/indications/DBCOND0067007/clinical_trials/DB16224?phase=2&status=recruiting

Atopic Dermatitis (AD) Recruiting Phase 2 Trials for ... Atopic Dermatitis (AD) Recruiting Phase 2 Trials for Lutikizumab (DB16224) ; NCT06718101. A Study to Evaluate the Effectiveness and Safety of Treatments, Either ...