A Study of LY3041658 in Adults With Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3041658 in Adults With Moderate-to-Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04493502
• Other study ID #: 17497
• Secondary ID: I7P-MC-DSAD
• Status: Completed
• Phase: Phase 2
• Start date: August 26, 2020
• Est. completion date: October 13, 2022

Study information

• Verified date: April 1, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 13, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Placebo
Administered IV
• LY3041658
Administered IV

Locations

Country	Name	City	State
Australia	Sunshine Coast University Hospital	Birtinya	QID
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	Westmead Hospital	Northmead	New South Wales
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Holdsworth House Medical Practice	Sydney
United States	Allcutis Research, Inc.	Beverly	Massachusetts
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	UC Physicians Office Dermatology	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	First OC Dermatology	Fountain Valley	California
United States	Skin Care Research, Inc	Hollywood	Florida
United States	Dermatology Research Associates	Los Angeles	California
United States	Marietta Dermatology Clinical Research	Marietta	Georgia
United States	Nova Clinical Research, LLC	Miami	Florida
United States	ALLCUTIS Research	Portsmouth	New Hampshire
United States	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Advanced Medical Research	Sandy Springs	Georgia
United States	ForCare Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16	The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules [AN count]) with no increase in abscess count (A count) and no increase in draining fistulae count (DF count) relative to baseline. Non-responder imputation (NRI): Participants with missing data were considered non-responders.	Week 16
Secondary	Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count	Mean Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the Hidradenitis Suppurativa (HS) affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.	Baseline, Week 16
Secondary	Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)	The Skin Pain - HS Numeric Rating Scale (NRS) is a patient-administered, single-question, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no skin pain" and 10 representing "skin pain as bad as you can imagine." The recall period is 7 days.	Baseline, Week 16

External Links

•   A Study of LY3041658 in Adults With Hidradenitis Suppurativa