Phase 2
N=72
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT04493502 ↗Enrolled (actual)
72
Serious AEs
1.9%
Results posted
Apr 2023
Primary outcome: Primary: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 — 31.8; 48.9 percentage of participants — p=0.189
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); LY3041658 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 |
31.8; 48.9 | 0.189 |
| SECONDARY Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count |
-1.85; -6.52 | 0.024 sig |
| SECONDARY Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS) |
-1.83; -1.78 | 0.949 |
Summary
The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of HS for at least 6 months
- Have HS lesions in at least 2 different anatomic areas
- Have inadequate response or intolerance to a 28 day course of oral antibiotics
- Have a total count of abscesses and inflammatory nodules greater than or equal to 4
- Agree to use a topical antiseptic daily
- Agree to stop using topical antibiotics during the study. In certain cases, oral antibiotics will be allowed
Exclusion Criteria
- Have more than 20 draining fistulae
- Have received any biologic medication (adalimumab, etc.) for the treatment of HS
- Plan to use oral opioids for HS-related pain during the study
- Uncontrolled depression or suicidal thoughts
Data sourced from ClinicalTrials.gov (NCT04493502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.