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

NCT06524635 | Recruiting Phase 2 FDA Drug

• 1 other identifier: M24-922
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  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.

  Up to Approximately 30 weeks

Study Arms (4)

SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-Naïve

EXPERIMENTAL

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

SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate Response

EXPERIMENTAL

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

SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïve

EXPERIMENTAL

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

Drug: Lutikizumab

SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR)

EXPERIMENTAL

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

Drug: Lutikizumab

Interventions

Lutikizumab DRUG

Subcutaneous (SC) Injection

Also known as: ABT-981

SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate Response; SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-Naïve; SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR); SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïve

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

Physioseq, LLC /ID# 267266

Sacramento, California, 95825, United States

RECRUITING

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

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Hidradenitis Suppurativa; Dermatitis, Atopic

Interventions

lutikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (2)