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NCT06524635 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Atopic Dermatitis and Hidradenitis Suppurativa, sponsored by AbbVie.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
2
Study locations

NCT06524635 is a Phase 2 study of Atopic Dermatitis and Hidradenitis Suppurativa that is actively recruiting participants, run by AbbVie. The registered enrollment target is 60 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT06524635, a Phase 2 study of Atopic Dermatitis and Hidradenitis Suppurativa, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
2
Study locations

Study 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 Studied

Atopic Dermatitis Hidradenitis Suppurativa

Interventions

  • DRUG Lutikizumab

Study Locations (2)

California

  • Physioseq, LLC /ID# 267266 - Sacramento

Michigan

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

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-08-14
Est. Completion 2027-02
Phase Phase 2

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06524635

The ClinicalTrials.gov registry entry for NCT06524635 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (90% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Lutikizumab is the first listed.

NCT06524635 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Michigan.

Frequently Asked Questions

What is clinical trial NCT06524635 about?

NCT06524635 is a clinical study titled "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". 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 mod...

What is the current status of trial NCT06524635?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-08-14. Estimated completion is 2027-02.

What conditions does trial NCT06524635 study?

This clinical trial studies the following conditions: Atopic Dermatitis, Hidradenitis Suppurativa.

What interventions are being tested in trial NCT06524635?

The interventions under investigation include: Lutikizumab (DRUG).

Who is sponsoring clinical trial NCT06524635?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06524635 being conducted?

This trial has 2 study locations across California, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.