Lutikizumab for Atopic Dermatitis

Recruiting at 1 trial location

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Malignancy, Active skin 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: 14-15 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, lutikizumab, to determine its effectiveness for moderate to severe skin conditions like hidradenitis suppurativa (HS) and atopic dermatitis (AD). The researchers aim to understand how the drug affects the skin and whether it alleviates symptoms such as pain and discomfort. In one part of the trial, participants with HS will receive injections, while those with AD will receive a different dose, both administered over several weeks. This study may suit individuals who have had HS for at least six months or AD for at least a year and have not responded well to other treatments. Participants should be prepared for frequent clinic visits and tests. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should be naïve to biologic treatments or have had an inadequate response to certain therapies, which might imply some restrictions. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that lutikizumab is likely to be safe for humans?

Research has shown that lutikizumab has been tested in individuals with moderate to severe skin conditions, such as hidradenitis suppurativa (HS) and atopic dermatitis (AD). In these studies, participants received varying doses of lutikizumab, and results indicated improvement in skin conditions for many patients.

Regarding safety, lutikizumab has generally been well-tolerated. Some side effects occurred, mostly mild, such as minor skin reactions at the injection site or mild flu-like symptoms. Serious side effects were rare.

The safety data from these studies suggest that lutikizumab is safe for use in these skin conditions, although ongoing research continues to evaluate its full safety profile. This information may help prospective trial participants feel more informed about the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for atopic dermatitis?

Researchers are excited about Lutikizumab for treating atopic dermatitis because it offers a fresh approach compared to existing options like corticosteroids and Dupilumab. Unlike other treatments, Lutikizumab targets specific inflammatory pathways by neutralizing interleukin-1 alpha and beta, which are proteins involved in inflammation. This new mechanism of action could offer better results for patients who haven't seen success with current treatments. Additionally, Lutikizumab might provide a more tailored treatment option for those who don't respond adequately to Dupilumab or have never tried biologics before, offering new hope for a wider range of patients.

What evidence suggests that this trial's treatments could be effective for hidradenitis suppurativa and atopic dermatitis?

This trial will evaluate the effectiveness of Lutikizumab for both hidradenitis suppurativa (HS) and atopic dermatitis (AD). Research has shown that Lutikizumab may help treat both conditions. For HS, studies found that patients taking Lutikizumab experienced less skin pain and fewer draining tunnels compared to those on a placebo. In cases of AD, Lutikizumab led to a noticeable decrease in eczema severity for some patients. These early results suggest that Lutikizumab could be a promising treatment option for individuals with moderate to severe HS and AD. Participants in this trial will receive different doses of Lutikizumab based on their specific condition and treatment history. ^{1 2 4 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with moderate to severe Hidradenitis Suppurativa (HS) or Atopic Dermatitis (AD), also known as eczema, can join this study. Participants will receive injections of a new drug called Lutikizumab and must be willing to undergo frequent medical assessments and tests.

Inclusion Criteria

I have never had biologic treatment for AD or didn't respond well to dupilumab after 8 weeks.

I have had moderate-to-severe hidradenitis suppurativa for at least 6 months.

I have had moderate-to-severe atopic dermatitis for at least a year.

Exclusion Criteria

I do not have a skin condition that could affect the study's assessment.

I haven't had any cancer except for skin cancer or localized cervical cancer in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of lutikizumab for up to 15 weeks in Sub-Study 1 and up to 14 weeks in Sub-Study 2

14-15 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Open-label extension (optional)

Participants in Sub-Study 1 who show therapeutic benefit may continue to receive lutikizumab for up to an additional 140 weeks

140 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lutikizumab

Trial Overview The trial is testing the effects of Lutikizumab on skin diseases HS and AD. It's divided into two parts: one for HS patients receiving injections up to week 15, another for AD patients up to week 14, followed by a follow-up period.

How Is the Trial Designed?

Group I: SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïve Experimental Treatment 1 Intervention

AD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.

Group II: SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR) Experimental Treatment 1 Intervention

AD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.

Group III: SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-Naïve Experimental Treatment 1 Intervention

HS Bio-naïve participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration, with the option to enter an open-label LTE to continue to receive Lutikizumab Dose B at Week 16 and every week thereafter.

Group IV: SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate Response Experimental Treatment 1 Intervention

Tumor Necrosis Factor-Inadequate Response (TNF-IR) participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration.

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

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. 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 ... Patients receiving lutikizumab 300 mg weekly and 300 mg every other week achieved higher rates of improved skin pain via NRS30 and HiSCR75, a higher threshold ...

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

A Study to Assess Molecular Changes in Adult Participants ... Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD. This study will consist of 2 sub-studies: Sub-Study 1 moderate ...

5. dermatologytimes.com dermatologytimes.com/view/lutikizumab-demonstrates-positive-results-in-phase-2-trial-for-hidradenitis-suppurativa

Lutikizumab Demonstrates Positive Results in Phase 2 ... Higher response rates were observed in patients treated with lutikizumab. The drug will now advance to phase 3 clinical trials.

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 ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-molecular-changes-in-adult-participants-with-moderate-to-severe-hidradenitis-suppu

A Study to Assess Molecular Changes in Adult Participants ... Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD. This study will consist of 2 sub-studies: Sub- ...