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OpenTrials
Completed

NCT Number: NCT04493502

A Study of LY3041658 in Adults With Hidradenitis Suppurativa

The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Westmead Hospital, Northmead, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Administered IV

LY3041658

Drug

Administered IV

Primary outcomes

  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

    Time frame: 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.

Secondary outcomes

  1. Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count

    Time frame: Baseline, Week 16

    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.

  2. Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)

    Time frame: Baseline, Week 16

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 30, 2020
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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