Recruiting
Phase 2

Lutikizumab

Sponsor:

AbbVie

Code:

NCT06524635

Conditions

Hidradenitis Suppurativa

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lutikizumab

Study Details

Brief summary:

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

Study ID

NCT06524635

Start date

Aug 14, 2024

Status verified date

Jan, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Lutikizumab

Subcutaneous (SC) Injection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Physioseq, LLC /ID# 267266

Recruiting

Sacramento, California, United States, 95825

Contacts

Site Coordinator

916-603-2157 ext.2

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

Recruiting

Ann Arbor, Michigan, United States, 48109

More Information

Sponsor

AbbVie

Last update posted

Jan 24, 2025

Last verified

Jan, 2025

Keywords

  • Hidradenitis Suppurativa (HS)
  • Atopic Dermatitis (AD)
  • Lutikizumab
  • ABT-981

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by AbbVie on 2025-01-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.