NCT06524635 · AbbVie
A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab
What this study is about
Hidradenitis suppurativa (HS) and atopic dermatitis (AD) are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort. The purpose of this study is to assess molecular changes in adult participants with moderate to severe HS or with moderate to severe AD.
View original scientific description
Hidradenitis suppurativa (HS) and atopic dermatitis (AD) are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort. The purpose of this study is to assess molecular changes in adult participants with moderate to severe HS or with moderate to severe AD. Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD.
Interventions
DRUG
Lutikizumab
Subcutaneous (SC) Injection
Primary outcome measures
Number of Participants With Adverse Events (AEs)
Time frame: Up to Approximately 30 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Sub-Study 1 hidradenitis suppurativa (HS):
- Participants with a diagnosis of moderate-to-severe HS for at least 6 months prior to Baseline as determined by the investigator
- Participants naïve to biologic treatment for HS or must have a prior inadequate response or loss of response to anti-TNF therapy for HS (\>= 12 weeks of therapy).
- Sub-Study 2 atopic dermatitis (AD):
- Participants with a diagnosis of moderate-to-severe AD with onset of symptoms at least 1 year prior to Baseline.
- Participants naïve to biologic treatment for AD or must have a prior inadequate response or loss of response to dupilumab for AD (defined as \>= 8 weeks of therapy with dupilumab).
Exclusion criteria
- History of any malignancy within the last 5 years except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
- History of active skin disease (other than HS for Sub-Study 1 or AD for Sub-Study 2) that could interfere with the as
Where
- Sacramento, California
- Ann Arbor, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 24, 2025 · Source of record for eligibility and locations