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Monoclonal Antibodies

Lutikizumab for Hidradenitis Suppurativa (Intrepid Trial)

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.

Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately week 62

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug called lutikizumab for the treatment of a skin condition called Hidradenitis suppurativa (HS), which causes painful lumps and abscess

Who is the study for?

This trial is for adults and adolescents with moderate to severe Hidradenitis Suppurativa (HS), a painful skin condition. Participants must have been diagnosed at least 6 months ago, have five or more abscesses or nodules, and HS lesions in two areas of the body, one being at least Hurley Stage II.

What is being tested?

The study tests Lutikizumab against a placebo in treating HS. Initially, participants are randomly assigned to receive either Lutikizumab or placebo injections weekly for 16 weeks. Afterwards, they may continue with different dosing schedules of Lutikizumab for up to 36 weeks.

What are the potential side effects?

Potential side effects include reactions at the injection site, increased risk of infections due to immune system suppression by Lutikizumab, headaches, nausea and potential unknown risks as it's an investigational drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My HS condition is at least at a moderate severity stage.

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I have HS lesions in two or more separate areas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately week 62

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately week 62

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately week 62 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)

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75

Secondary study objectives

Change from Baseline in Dermatology Life Quality Index (DLQI)

Change from Baseline in HSSA

Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Period 2: Placebo to Lutikizumab Group Every WeekExperimental Treatment1 Intervention

Participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52

Group II: Period 2: Placebo to Lutikizumab Group Every Other WeekExperimental Treatment2 Interventions

The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52

Group III: Period 2: Placebo to Lutikizumab GroupExperimental Treatment1 Intervention

Participants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week.

Group IV: Period 2: Lutikizumab Every WeekExperimental Treatment1 Intervention

Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52

Group V: Period 2: Lutikizumab Every Other WeekExperimental Treatment2 Interventions

Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52

Group VI: Period 1Experimental Treatment2 Interventions

Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met