Hidradenitis SuppurativaPhase 2NCT04493502
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
A Phase 2 study testing LY3041658 in people with Hidradenitis Suppurativa, run by Eli Lilly and Company at 20 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- LY3041658
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 26 Aug 2020to 13 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States15 sites
Allcutis Research, Inc.
Beverly, Massachusetts, 01915
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
UC Physicians Office Dermatology
Cincinnati, Ohio, 45267
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
First OC Dermatology
Fountain Valley, California, 92708
Skin Care Research, Inc
Hollywood, Florida, 33021
Dermatology Research Associates
Los Angeles, California, 90045
Marietta Dermatology Clinical Research
Marietta, Georgia, 30060
Nova Clinical Research, LLC
Miami, Florida, 33125
ALLCUTIS Research
Portsmouth, New Hampshire, 03801
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Advanced Medical Research
Sandy Springs, Georgia, 30328
Washington University School of Medicine
St Louis, Missouri, 63110
ForCare Clinical Research
Tampa, Florida, 33613-1244
Australia5 sites
Sunshine Coast University Hospital
Birtinya, QID, 4575
Fremantle Dermatology
Fremantle, Western Australia, 6160
Westmead Hospital
Northmead, New South Wales, 2152
The Royal Melbourne Hospital
Parkville, Victoria, 03050
Holdsworth House Medical Practice
Sydney, 2010
About this study
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
The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Placebo, LY3041658
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Administered IV
LY3041658Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3041658 | Experimental | Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W). Receives: Drug: LY3041658 |
| Placebo | Placebo comparator | Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16. Receives: Drug: Placebo; Drug: LY3041658 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (2)
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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start26 Aug 2020
- Primary completion15 Mar 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493502
- Sponsor's protocol ID
- 17497
- Other IDs
- I7P-MC-DSAD
- Status last verified
- 1 Apr 2023
- First submitted
- 29 Jul 2020
- Last updated
- 28 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41061970
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04493502
- Acronym / sponsor ID
- 17497
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Posted 28 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3041658 | Experimental | Drug: LY3041658Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W). |
| Placebo | Placebo comparator | Drug: Placebo, Drug: LY3041658Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAdministered IV | Drug | Placebo |
| LY3041658Administered IV | Drug | LY3041658, Placebo |
Primary outcome
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.
2 secondary outcomes
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 to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41061970Forman 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.
- A Study of LY3041658 in Adults With Hidradenitis SuppurativaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3041658 in people with Hidradenitis Suppurativa, run by Eli Lilly and Company at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04493502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.