Clinical trial NCT04493502: A Study of LY3041658 in Adults With Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count
timeFrame: Baseline, Week 16
measure: Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Hollywood
country: United States
facility: Skin Care Research, Inc
state: Florida
city: Miami
country: United States
facility: Nova Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Beverly
country: United States
facility: Allcutis Research, Inc.
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Portsmouth
country: United States
facility: ALLCUTIS Research
state: New Hampshire
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: UC Physicians Office Dermatology
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Northmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: QID
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: