Lutikizumab for Eczema

Recruiting in Rolling Meadows (>99 mi)

+17 other 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

Trial Summary

What is the purpose of this trial?

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. 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 multiple substudies. This study will consist of multiple sub-studies, Sub-Study 1 will have a randomized, placebo controlled period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio. In Sub-Study 1, participants will receive subcutaneous (SC) injections of lutikizumab or matching placebo every other week for 16 weeks followed by an additional 32 weeks of subcutaneous (SC) injections of lutikizumab every other week for a total of 52 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.

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.

How does the drug Lutikizumab differ from other eczema treatments?

Lutikizumab is unique because it specifically targets interleukin 13, a key protein involved in the inflammation process of eczema, potentially offering a more focused approach compared to other treatments like dupilumab, which targets both interleukin 4 and 13. This specificity might result in fewer side effects, such as conjunctivitis, which is more common with broader-targeting drugs. ^{1 2 3 4 5}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Managing Atopic Dermatitis with Lebrikizumab - The Evidence to Date. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Inhibition of IL-13: A New Pathway for Atopic Dermatitis [Formula: see text]. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

IL-4Rα Inhibitor for Atopic Disease. [2019]

4. United States 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). [2023]

5. Australia 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. [2022]