A Study of LY3041658 in Adults With Hidradenitis Suppurativa
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ClinicalTrials.gov Identifier: NCT04493502 |
Recruitment Status :
Completed
First Posted : July 30, 2020
Results First Posted : April 28, 2023
Last Update Posted : April 28, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hidradenitis Suppurativa | Drug: Placebo Drug: LY3041658 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 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 |
Actual Primary Completion Date : | March 15, 2022 |
Actual Study Completion Date : | October 13, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: LY3041658
Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
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Drug: LY3041658
Administered IV |
Placebo Comparator: Placebo
Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
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Drug: Placebo
Administered IV Drug: LY3041658 Administered IV |
- 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.
- 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.
- 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.

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

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 |
Documents provided by 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 |
Results First Posted: | April 28, 2023 |
Last Update Posted: | April 28, 2023 |
Last Verified: | April 1, 2023 |
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 Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |