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

Purpose

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. This study will consist of 2 sub-studies: Sub-Study 1 moderate to severe hidradenitis suppurativa and Sub-Study 2 moderate to severe atopic dermatitis. Approximate 60 participants will be enrolled in the study at approximately 2 sites in the US. In Sub-Study 1 HS participants will receive subcutaneous (SC) injections of lutikizumab for up to week 15 with a 70-day follow-up period. In Sub-Study 2 AD, participants will receive subcutaneous (SC) injections of lutikizumab for up to week 14 with a 70-day follow-up period. The study duration for Sub-Studies 1 and 2 is expected to last up to 30 weeks. Participants in Sub-Study 1 (HS) who complete Week 16 and showed a therapeutic benefit to lutikizumab, as confirmed by the investigator, will have the option to enter an open-label long-term extension (LTE) to continue to receive lutikizumab for up to an additional 140 weeks, followed by a 70-day follow-up period. 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.

Conditions

  • Hidradenitis Suppurativa
  • Atopic Dermatitis

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 assessment of HS (for Sub-Study 1) or AD (for Sub-Study 2), including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-Naïve 		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.
  • Drug: Lutikizumab
    Subcutaneous (SC) Injection
    Other names:
    • ABT-981
Experimental
SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate Response 		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.
  • Drug: Lutikizumab
    Subcutaneous (SC) Injection
    Other names:
    • ABT-981
Experimental
SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïve 		AD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
  • Drug: Lutikizumab
    Subcutaneous (SC) Injection
    Other names:
    • ABT-981
Experimental
SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR) 		AD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
  • Drug: Lutikizumab
    Subcutaneous (SC) Injection
    Other names:
    • ABT-981

Recruiting Locations

Physioseq, LLC /ID# 267266
Sacramento, California 95825
Contact:
Site Coordinator
916-603-2157 ext.2

University of Michigan Health System - Ann Arbor /ID# 267275
Ann Arbor, Michigan 48109

More Details

NCT ID
NCT06524635
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center