Testing eltrekibart for treating moderate to severe hidradenitis suppurativa in adults
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This study is testing a new medication called eltrekibart to see if it can help adults with moderate to severe hidradenitis suppurativa feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 75 sites (Phoenix, Arizona and 74 other locations) |
| Trial ID | NCT06046729 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of eltrekibart in adults diagnosed with moderate to severe hidradenitis suppurativa (HS). Participants will receive either eltrekibart or a placebo over approximately 62 weeks, with up to 31 visits to assess the appropriate dosing and frequency. The study aims to determine the optimal treatment regimen for further clinical development in managing HS.
Who should consider this trial
Good fit: Ideal candidates are adults with a diagnosis of hidradenitis suppurativa for at least 12 months and specific lesion characteristics.
Not a fit: Patients with more than 20 draining fistulae or recent surgical treatment for HS may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of hidradenitis suppurativa, leading to better patient outcomes.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating hidradenitis suppurativa with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Phoenix, Arizona and 74 other locations
- Medical Dermatology Specialists — Phoenix, Arizona, United States (Recruiting)
- Saguaro Dermatology Associates, LLC - Probity - PPDS — Phoenix, Arizona, United States (Recruiting)
- Arkansas Research Trials, LLC — North Little Rock, Arkansas, United States (Recruiting)
- Northwest Arkansas Clinical Trials Center — Rogers, Arkansas, United States (Recruiting)
- First OC Dermatology Research Inc — Fountain Valley, California, United States (Recruiting)
- Center For Dermatology Clinical Research, Inc. — Fremont, California, United States (Not_yet_recruiting)
- Dermatology Research Associates — Los Angeles, California, United States (Recruiting)
- Dermatology Institute and Skin Care Center — Santa Monica, California, United States (Recruiting)
- University of Connecticut — Farmington, Connecticut, United States (Recruiting)
- Direct Helpers Research Center — Hialeah, Florida, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Skin Research of South Florida — Miami, Florida, United States (Recruiting)
- ForCare Clinical Research — Tampa, Florida, United States (Recruiting)
- Alliance Clinical Research of Tampa — Tampa, Florida, United States (Recruiting)
- Olympian Clinical Research — Tampa, Florida, United States (Recruiting)
- Advanced Medical Research, PC — Sandy Springs, Georgia, United States (Recruiting)
- NorthShore Medical Group Dermatology - Skokie — Skokie, Illinois, United States (Recruiting)
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (Recruiting)
- Equity Medical - Bowling Green — Bowling Green, Kentucky, United States (Recruiting)
- Derm Research LLC — Louisville, Kentucky, United States (Not_yet_recruiting)
- Care Access-Marriottsville — Marriottsville, Maryland, United States (Not_yet_recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Revival Research Institute - Troy — Troy, Michigan, United States (Recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
- Skin Specialists, P.C — Omaha, Nebraska, United States (Recruiting)
- ActivMed Practices & Research, Inc. — Portsmouth, New Hampshire, United States (Recruiting)
- Darst Dermatology — Charlotte, North Carolina, United States (Recruiting)
- Dermatology Specialists of Charlotte — Charlotte, North Carolina, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Apex Clinical Research Center — Mayfield Heights, Ohio, United States (Recruiting)
- DermDox Centers for Dermatology — Camp Hill, Pennsylvania, United States (Recruiting)
- DermDox Dermatology Centers — Sugarloaf, Pennsylvania, United States (Not_yet_recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Columbia Dermatology & Aesthetics — Columbia, South Carolina, United States (Recruiting)
- International Clinical Research - Tennessee (IC Research) — Murfreesboro, Tennessee, United States (Recruiting)
- Advanced Research Experts — Nashville, Tennessee, United States (Recruiting)
- Modern Research Associates — Dallas, Texas, United States (Recruiting)
- North Texas Clinical Research — Frisco, Texas, United States (Recruiting)
- Jordan Valley Dermatology Center — South Jordan, Utah, United States (Recruiting)
- Dermatology Specialists of Spokane — Spokane, Washington, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- East Sydney Doctors — Darlinghurst, New South Wales, Australia (Recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
- Sunshine Coast University Hospital — Birtinya, Queensland, Australia (Not_yet_recruiting)
- Sinclair Dermatology - East Melbourne — East Melbourne, Victoria, Australia (Recruiting)
- Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Fremantle Dermatology — Fremantle, Western Australia, Australia (Recruiting)
- Holdsworth House Medical Practice — Sydney, Australia (Recruiting)
- Beacon Dermatology — Calgary, Alberta, Canada (Recruiting)
+25 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.