Lutikizumab for Hidradenitis Suppurativa

Recruiting in Palo Alto (17 mi)

+78 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AbbVie

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called lutikizumab to help adults with a painful skin condition called hidradenitis suppurativa (HS) who haven't been helped by other treatments. The drug works by reducing inflammation in the skin.

Eligibility Criteria

Adults with moderate to severe Hidradenitis Suppurativa (HS) who didn't get better with anti-TNF therapy can join. They must have at least 5 abscesses and nodules in two different body areas, been diagnosed with HS for a year or more, and not tried biologic treatments yet.

Inclusion Criteria

I have tried anti-TNF treatment for HS without success.

I have HS lesions in at least two different body areas.

Total abscess and inflammatory nodule (AN) count of >= 5 at Baseline

+2 more

Exclusion Criteria

I have no active skin conditions that could affect HS assessment.

Participant Groups

The trial is testing Lutikizumab (ABT-981), an experimental drug, against a placebo. Participants will be randomly assigned to receive either the drug or placebo through weekly injections for up to 16 weeks in the main study, and possibly longer in a sub-study.

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Sub-study: Group 2Experimental Treatment1 Intervention

Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.

Group II: Sub-study: Group 1Experimental Treatment1 Intervention

Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.

Group III: Main Study: Lutikizumab Dose CExperimental Treatment1 Intervention

Lutikizumab Dose C every other week

Group IV: Main Study: Lutikizumab Dose BExperimental Treatment1 Intervention

Lutikizumab Dose B every other week

Group V: Main Study: Lutikizumab Dose AExperimental Treatment1 Intervention