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Monoclonal Antibodies

Lutikizumab for Atopic Dermatitis

Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 30 weeks
Awards & highlights

Summary

"This trial aims to study molecular changes in adults with moderate to severe hidradenitis suppurativa (HS) or atopic dermatitis (AD). The study will test an investigational drug called

Who is the study for?
Adults with moderate to severe Hidradenitis Suppurativa (HS) or Atopic Dermatitis (AD), also known as eczema, can join this study. Participants will receive injections of a new drug called Lutikizumab and must be willing to undergo frequent medical assessments and tests.
What is being tested?
The trial is testing the effects of Lutikizumab on skin diseases HS and AD. It's divided into two parts: one for HS patients receiving injections up to week 15, another for AD patients up to week 14, followed by a follow-up period.
What are the potential side effects?
Possible side effects from Lutikizumab are not specified here but may include reactions at the injection site, increased risk of infection due to immune system changes, or other inflammatory responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have never had biologic treatment for AD or didn't respond well to dupilumab after 8 weeks.
Select...
I have not tried or did not respond well to anti-TNF therapy for HS after 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 30 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Events (AEs)

Trial Design

4Treatment groups
Experimental Treatment
Group I: SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïveExperimental Treatment1 Intervention
AD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
Group II: SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR)Experimental Treatment1 Intervention
AD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
Group III: SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-NaïveExperimental Treatment1 Intervention
HS Bio-naïve participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration.
Group IV: SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate ResponseExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,718 Total Patients Enrolled
13 Trials studying Hidradenitis Suppurativa
4,228 Patients Enrolled for Hidradenitis Suppurativa
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
156,038 Total Patients Enrolled
6 Trials studying Hidradenitis Suppurativa
3,165 Patients Enrolled for Hidradenitis Suppurativa
~40 spots leftby Feb 2027
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