A Phase 2b Study to Evaluate Eltrekibart in Adults with Moderate to Severe Hidradenitis Suppurativa

Phase 2

Active, not recruiting

• Conditions: Moderate to Severe Hidradenitis Suppurativa
• Interventions: Drug: Placebo; Drug: Eltrekibart

• Registration Number: 2023-505608-43-00
• Lead Sponsor: Eli Lilly & Co.

Brief Summary

To test if eltrekibart is superior to placebo in inducing Hidradenitis Suppurativa Clinical Response (HiSCR50) in adult participants with moderate-to-severe HS

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2023-10-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-10
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1. Have a diagnosis of HS for at least 12 months. 2. Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be Hurley Stage II or III. 3. Have an (abscess plus inflammatory nodule) count of at least 5. 4. Agree to use topical antiseptics daily. 5. Had an inadequate response or intolerance to a 28-day course of oral antibiotics.

Exclusion Criteria

1. Have more than 20 draining fistulae. 2. Have had surgical treatment for HS in the last 4 weeks before randomization. 3. Have an active skin disease or condition, that could interfere with the assessment of HS. 4. Have a current or recent acute, active infection. 5. Are immunocompromised. 6. Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be given.
Eltrekibart Dose 1	Eltrekibart	Eltrekibart will be given subcutaneously (SC).
Eltrekibart Dose 2	Eltrekibart	Eltrekibart will be given SC.
Eltrekibart Dose 3	Eltrekibart	Eltrekibart will be given SC.

Primary Outcome Measures

Name	Time	Method
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Time Frame: Week 16]		Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Time Frame: Week 16]

Secondary Outcome Measures

Name	Time	Method
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules	Baseline, Week 16
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)	Baseline, Week 16
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart	Baseline through Week 16

Trial Locations

Locations (74)

Medical Dermatology Specialists; 🇺🇸 Phoenix, Arizona, United States

Saguaro Dermatology Associates, LLC - Probity - PPDS; 🇺🇸 Phoenix, Arizona, United States

Arkansas Research Trials, LLC; 🇺🇸 North Little Rock, Arkansas, United States

Northwest Arkansas Clinical Trials Center; 🇺🇸 Rogers, Arkansas, United States

First OC Dermatology Research Inc; 🇺🇸 Fountain Valley, California, United States

Center For Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Dermatology Institute and Skin Care Center; 🇺🇸 Santa Monica, California, United States

University of Connecticut; 🇺🇸 Farmington, Connecticut, United States

Direct Helpers Research Center; 🇺🇸 Hialeah, Florida, United States

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