Lutikizumab for Atopic Dermatitis
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.12345Why 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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
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?
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Treatment groups
Experimental Treatment
AD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
AD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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
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 ...
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 ...
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 ...
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-suppurativaLutikizumab 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=recruitingAtopic 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-suppuA 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- ...
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