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Taking people in United StatesPhase 2

Studies lutikizumab's effect on molecules in two inflammatory skin diseases

Tests lutikizumab injections in adults with hidradenitis suppurativa or atopic dermatitis.

Key facts

Who runs it
AbbVie
Where
Ann Arbor and Sacramento, United StatesSee the 2 sites
Trial code
Registry title
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
Status
Recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
14 Aug 2024
Expected to end
Feb 2027
Type of study
Interventional, 4 groups
Treatments tested
  • Lutikizumab
Record updated
24 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate-to-severe hidradenitis suppurativa (HS) or moderate-to-severe atopic dermatitis (AD). It studies molecular changes during lutikizumab injections.

Age
18 Years to 75 Years
Sex
All sexes
Disease stage
Moderate-to-severe HS, diagnosed at least 6 months before the start. Or moderate-to-severe AD, with symptoms starting at least 1 year before the start.
Earlier treatment
People with HS must have had no biologic treatment for HS, or an inadequate or lost response to anti-TNF therapy (at least 12 weeks). People with AD must have had no biologic treatment for AD, or an inadequate or lost response to dupilumab (at least 8 weeks).

Main reasons for not taking part

  • Any cancer in the last 5 years, except successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix
  • Another active skin disease that could interfere with judging HS or AD
  • Skin infection needing systemic treatment within 4 weeks of the start

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United States

  • University of Michigan Health System - Ann Arbor /ID# 267275Ann Arbor, United StatesTaking people
  • Physioseq, LLC /ID# 267266Sacramento, United StatesContact: Site CoordinatorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-NaïveTreatment being tested

    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.

    Treatment: Lutikizumab

  • SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate ResponseTreatment being tested

    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.

    Treatment: Lutikizumab

  • SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïveTreatment being tested

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

    Treatment: Lutikizumab

  • SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR)Treatment being tested

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

    Treatment: Lutikizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter Open-Label Interventional Biomarker Study of Lutikizumab in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa or Adult Subjects With Moderate-to-Severe Atopic Dermatitis
Plain-language title
Studies lutikizumab's effect on molecules in two inflammatory skin diseasesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06524635, who can take part
Record updated
24 January 2025