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

Part of paid clinical trials in Sacramento, California.

Sponsor
AbbVie
Study ID
NCT06524635
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 14, 2024
Status verified
Jan 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Approximately 30 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Physioseq, LLC /ID# 267266SacramentoCalifornia95825
Site Coordinator
916-603-2157 ext.2
University of Michigan Health System - Ann Arbor /ID# 267275Ann ArborMichigan48109-

Find similar trials in Sacramento, CA

By condition
Atopic dermatitis / eczemaHidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Physioseq, LLC· Sacramento, CAUniversity of Michigan Health System - Ann Arbor· Ann Arbor, MI

Related Studies