A Study of LY3041658 in Adults With Hidradenitis Suppurativa
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04493502 |
Recruitment Status :
Recruiting
First Posted : July 30, 2020
Last Update Posted : January 20, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hidradenitis Suppurativa | Drug: Placebo Drug: LY3041658 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 26, 2020 |
Estimated Primary Completion Date : | December 6, 2021 |
Estimated Study Completion Date : | July 4, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: LY3041658
LY3041658 given intravenously (IV).
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Drug: LY3041658
Given IV |
Placebo Comparator: Placebo
Placebo given IV. Participants will switch to LY3041658 given IV after week 16.
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Drug: Placebo
Given IV Drug: LY3041658 Given IV |
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 16 ]Percentage of Participants Achieving HiSCR
- Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules [ Time Frame: Baseline, Week 16 ]Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
- Mean Change from Baseline in Skin Pain on the HS Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 16 ]Mean Change from Baseline in Skin Pain on the HS NRS

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493502
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | ClinicalTrials.gov@lilly.com |

Study Director: | 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) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04493502 |
Other Study ID Numbers: |
17497 I7P-MC-DSAD ( Other Identifier: Eli Lilly and Company ) |
First Posted: | July 30, 2020 Key Record Dates |
Last Update Posted: | January 20, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Skin Diseases, Infectious Infection Suppuration |