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

No Placebo-Only Group

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

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I have never had biologic treatment for AD or didn't respond well to dupilumab after 8 weeks.

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I have not tried or did not respond well to anti-TNF therapy for HS after 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 30 weeks

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met