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| ID | Type | Description | Link |
|---|---|---|---|
| I7P-MC-DSAD | Other Identifier | Eli Lilly and Company |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3041658 | Experimental | Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W). |
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| Placebo | Placebo Comparator | Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered IV |
| |
| LY3041658 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Arkansas Clinical Trials Center | Rogers | Arkansas | 72758 | United States | ||
| First OC Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41061970 | Derived | Forman S, Patel DR, Kimball AB, Jaleel T, Laquer V, Wang T, Zhang Y, Shen L, Nirula A, Klekotka P. A randomized, double-blind, placebo-controlled phase 2 study of eltrekibart, a novel septa-specific monoclonal antibody to CXCR1/2 ligands, in adults with hidradenitis suppurativa. J Am Acad Dermatol. 2026 Feb;94(2):530-538. doi: 10.1016/j.jaad.2025.10.015. Epub 2025 Oct 6. |
| Label | URL |
|---|---|
| A Study of LY3041658 in Adults With Hidradenitis Suppurativa | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants were randomized in a 2:1 ratio to receive either 600 milligram (mg) LY3041658, or placebo in the double blind period (16 weeks).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/600 mg LY3041658 | Participants received placebo administered intravenously (IV) once every 2 weeks (Q2W) for 16 weeks in double blind period. Participants who previously assigned to placebo in double blind period received 600 mg LY3041658 administered IV Q2W until the last dosing visit in open-label period. Follow-up Period: Participants did not receive study drug during this period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Treatment (Week 0 - 16) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2021 | Mar 13, 2023 |
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| Drug |
Administered IV |
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| 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 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Skin Care Research, Inc | Hollywood | Florida | 33021 | United States |
| Nova Clinical Research, LLC | Miami | Florida | 33125 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613-1244 | United States |
| Marietta Dermatology Clinical Research | Marietta | Georgia | 30060 | United States |
| Advanced Medical Research | Sandy Springs | Georgia | 30328 | United States |
| Allcutis Research, Inc. | Beverly | Massachusetts | 01915 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| ALLCUTIS Research | Portsmouth | New Hampshire | 03801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| UC Physicians Office Dermatology | Cincinnati | Ohio | 45267 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Westmead Hospital | Northmead | New South Wales | 2152 | Australia |
| Sunshine Coast University Hospital | Birtinya | QID | 4575 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 03050 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | 6160 | Australia |
| Holdsworth House Medical Practice | Sydney | 2010 | Australia |
| FG001 | 600 mg LY3041658 / 600 mg LY3041658 | Participants received 600 mg LY3041658 administered IV Q2W in double blind and open-label period. Follow-up Period: Participants did not receive study drug during this period. |
| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Open-label Extension (Week 16 - 36) |
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| Post-treatment Follow-up (10 Weeks) |
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All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/600 mg LY3041658 | Participants received placebo administered intravenously (IV) once every 2 weeks (Q2W) for 16 weeks in double blind period. Participants who previously assigned to placebo in double blind period received 600 mg LY3041658 administered IV Q2W until the last dosing visit in open-label period. |
| BG001 | 600 mg LY3041658 / 600 mg LY3041658 | Participants received 600 mg LY3041658 administered IV Q2W in double blind and open-label period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Modified Intent-to-Treat (mITT) Population: All randomized participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
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| 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. | mITT Population: All randomized participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | count of abscess and inflammatory nodule | Baseline, Week 16 |
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| 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. | mITT Population: All randomized participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 16 |
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|
Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 600 mg LY3041658 _Double-Blind Treatment Period | Participants received 600 mg LY3041658 IV Q2W for 16 weeks. | 0 | 45 | 0 | 45 | 10 | 45 |
| EG001 | Placebo_Double-Blind Treatment Period | Participants received placebo IV Q2W for 16 weeks. | 0 | 22 | 2 | 22 | 2 | 22 |
| EG002 | 600 mg LY3041658_Open-Label Extension | Participants received 600 mg IV LY3041658 Q2W from week 16-34 weeks. | 0 | 49 | 1 | 49 | 13 | 49 |
| EG003 | Follow-Up Period | Participants did not receive study drug during this period. | 0 | 39 | 0 | 39 | 2 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Balanoposthitis | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
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| Scrotal operation | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-595-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2021 | Mar 13, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| Withdrawal by Subject |
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| Withdrawal by Subject |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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