Hidradenitis SuppurativaPhase 2NCT06046729
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study testing Eltrekibart in people with Hidradenitis Suppurativa, run by Eli Lilly and Company at 74 sites in 6 countries.
Trial summary
This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Eltrekibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 74 sitesin 6 countries
- Study dates
- 23 Oct 2023to 17 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of HS for at least 12 months.
- Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.
- Have an (abscess plus inflammatory nodule) count of at least 5.
- Agree to use topical antiseptics daily.
- Had an inadequate response or intolerance to a 28-day course of oral antibiotics.
Who cannot join
- Have more than 20 draining fistulae.
- Have had surgical treatment for HS in the last 4 weeks before randomization.
- Have an active skin disease or condition, that could interfere with the assessment of HS.
- Have a current or recent acute, active infection.
- Are immunocompromised.
- Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.
Trial locations and contacts
74 sites in 6 countries.
74 sites in 6 countries
United States42 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Equity Medical - Bowling Green
Bowling Green, Kentucky, 42104
DermDox Centers for Dermatology
Camp Hill, Pennsylvania, 17011
Medical University of South Carolina
Charleston, South Carolina, 29425
Darst Dermatology
Charlotte, North Carolina, 28277-8014
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Columbia Dermatology & Aesthetics
Columbia, South Carolina, 29212-8623
Modern Research Associates
Dallas, Texas, 75231
Duke University Medical Center
Durham, North Carolina, 27710-3038
University of Connecticut
Farmington, Connecticut, 06032
First OC Dermatology Research Inc
Fountain Valley, California, 92708
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
North Texas Clinical Research
Frisco, Texas, 75034
Direct Helpers Research Center
Hialeah, Florida, 33012
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Dermatology Research Associates
Los Angeles, California, 90045
Derm Research LLC
Louisville, Kentucky, 40217
Care Access-Marriottsville
Marriottsville, Maryland, 21104
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
University of Miami
Miami, Florida, 33125
Skin Research of South Florida
Miami, Florida, 33173-1407
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Clinical Research - Tennessee (IC Research)
Murfreesboro, Tennessee, 37130
Advanced Research Experts
Nashville, Tennessee, 37211
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117
Skin Specialists, P.C
Omaha, Nebraska, 68144
Medical Dermatology Specialists
Phoenix, Arizona, 85006
Saguaro Dermatology Associates, LLC - Probity - PPDS
Phoenix, Arizona, 85008
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, 03801
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Advanced Medical Research, PC
Sandy Springs, Georgia, 30328
Dermatology Institute and Skin Care Center
Santa Monica, California, 90404
NorthShore Medical Group Dermatology - Skokie
Skokie, Illinois, 60077-1049
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Dermatology Specialists of Spokane
Spokane, Washington, 99202-1332
Washington University School of Medicine
St Louis, Missouri, 63110
DermDox Dermatology Centers
Sugarloaf, Pennsylvania, 18249
ForCare Clinical Research
Tampa, Florida, 33613-1244
Alliance Clinical Research of Tampa
Tampa, Florida, 33615
Olympian Clinical Research
Tampa, Florida, 33615
Revival Research Institute - Troy
Troy, Michigan, 48084
Germany8 sites
Hautzentrum Friedrichshain - Dermatologie
Berlin, 10247
Hautarztpraxis Mahlow
Blankenfelde-Mahlow, Brandenburg, 15827
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
Bochum, North Rhine-Westphalia, 44791
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Hautklinik Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60596
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20251
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, Westfalen, 48149
Australia7 sites
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
East Sydney Doctors
Darlinghurst, New South Wales, 2010
Sinclair Dermatology - East Melbourne
East Melbourne, Victoria, 3002
Fremantle Dermatology
Fremantle, Western Australia, 6160
Alfred Hospital
Melbourne, Victoria, 3004
Holdsworth House Medical Practice
Sydney, 2010
Westmead Hospital
Westmead, New South Wales, 2145
Canada7 sites
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Beacon Dermatology
Calgary, Alberta, T3E 0B2
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3
Brunswick Dermatology Center
Fredericton, New Brunswick, E3B 1G9
DermEffects - Probity - PPDS
London, Ontario, N6H 5L5
Center de Recherche St Louis
Québec, Quebec, G1W 4R4
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
Poland7 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, 40-081
Dermoklinika-Centrum Medyczne s.c
Lodz, Łódź Voivodeship, 90-436
Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki
Malbork, Pomeranian Voivodeship, 82-200
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, Masovian Voivodeship, 02-507
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, 50-566
Wro Medica
Wroclaw, Lower Silesian Voivodeship, 51-685
Greece3 sites
Hospital of Venereal and Skin Diseases A.Syggros
Athens, Attica, 16121
University General Hospital of Heraklion Loc. 1
Heraklion, Irakleío, 711 10
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 56429
About this study
Official title: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Eltrekibart, Placebo
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrekibartDrug
Also called LY3041658
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Eltrekibart Dose 1 | Experimental | Eltrekibart will be given subcutaneously (SC). Receives: Drug: Eltrekibart |
| Eltrekibart Dose 2 | Experimental | Eltrekibart will be given SC. Receives: Drug: Eltrekibart |
| Eltrekibart Dose 3 | Experimental | Eltrekibart will be given SC. Receives: Drug: Eltrekibart |
| Placebo | Placebo comparator | Placebo will be given. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Measured: Week 16
Secondary outcomes (3)
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
Measured: Baseline, Week 16
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
Measured: Baseline, Week 16
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
Measured: Baseline through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 Oct 2023
- Primary completion30 Sep 2025
- Study completion17 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Phase 2b
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 352 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
- NCT06046729
- Sponsor's protocol ID
- 18518
- Other IDs
- I7P-MC-DSAF, 2023-505608-43-00, U1111-1292-6255, 2023
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT06046729
- Acronym / sponsor ID
- 18518
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Phase 2b
| Arm | Type | Receives |
|---|---|---|
| Eltrekibart Dose 1 | Experimental | Drug: EltrekibartEltrekibart will be given subcutaneously (SC). |
| Eltrekibart Dose 2 | Experimental | Drug: EltrekibartEltrekibart will be given SC. |
| Eltrekibart Dose 3 | Experimental | Drug: EltrekibartEltrekibart will be given SC. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be given. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of HS for at least 12 months.
- Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.
- Have an (abscess plus inflammatory nodule) count of at least 5.
- Agree to use topical antiseptics daily.
- Had an inadequate response or intolerance to a 28-day course of oral antibiotics.
Key exclusion criteria (6 listed)
- Have more than 20 draining fistulae.
- Have had surgical treatment for HS in the last 4 weeks before randomization.
- Have an active skin disease or condition, that could interfere with the assessment of HS.
- Have a current or recent acute, active infection.
- Are immunocompromised.
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 |
|---|---|---|
| EltrekibartAlso: LY3041658Administered SC | Drug | Eltrekibart Dose 1, Eltrekibart Dose 2, Eltrekibart Dose 3 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time frame: Week 16
3 secondary outcomes
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
Time frame: Baseline, Week 16
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
Time frame: Baseline, Week 16
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
Time frame: Baseline through Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe 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.
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
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
74 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltrekibart in people with Hidradenitis Suppurativa, run by Eli Lilly and Company at 74 sites in 6 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 5 inclusion and 6 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Germany, Australia, Canada, Poland and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.