Dermatology · Clinical trials
Hidradenitis Suppurativa Clinical Trials
Approved therapies, the pivotal-trial endpoints they were judged on, the magnitude of benefit — and the drugs that failed their endpoints, and why.
Indication overview
About hidradenitis suppurativa — and why its trials are hard
Hidradenitis suppurativa (HS) is a chronic, painful, inflammatory skin disease of the hair follicle affecting intertriginous areas such as the axillae, groin, buttocks, and inframammary folds. It is characterized by recurrent deep-seated nodules, abscesses, draining sinus tracts, and progressive scarring. The disease carries a substantial burden of pain, malodorous discharge, impaired mobility, and profound effects on quality of life and mental health, and it is associated with obesity, smoking, and metabolic and inflammatory comorbidities. Pathogenesis involves follicular occlusion followed by rupture and a dysregulated innate and adaptive immune response, with tumor necrosis factor and the IL-17 axis heavily implicated. Management combines lifestyle measures, topical and systemic antibiotics, hormonal therapy, surgery, and increasingly biologics. Adalimumab became the first FDA-approved biologic for moderate-to-severe HS in 2015 based on the PIONEER trials. The IL-17A inhibitor secukinumab was approved in 2023 (SUNSHINE/SUNRISE), and the dual IL-17A/F inhibitor bimekizumab was approved in 2024, expanding targeted options for this historically undertreated condition.
Approved therapies & pivotal evidence
What's been approved — and by how much it moved the endpoint
| Drug (brand) | Approved | Setting | Pivotal trial | Primary endpoint | Magnitude of benefit |
|---|---|---|---|---|---|
| Adalimumab (Humira) | 2015 | First FDA-approved biologic for moderate-to-severe HS (anti-TNF) | PIONEER I and PIONEER II (Phase 3, NEJM 2016) | Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12 | HiSCR achieved by ~42% (PIONEER I) and ~59% (PIONEER II) with weekly adalimumab vs ~26% and ~28% with placebo |
| Secukinumab (Cosentyx) | 2023 | Moderate-to-severe HS (IL-17A inhibitor) | SUNSHINE and SUNRISE (Phase 3, Lancet 2023) | HiSCR at week 16 | HiSCR ~42-45% with secukinumab every 2 weeks vs ~31-34% with placebo (significant in both trials for the q2w regimen) |
| Bimekizumab (Bimzelx) | 2024 | Moderate-to-severe HS (dual IL-17A and IL-17F inhibitor) | BE HEARD I and BE HEARD II (Phase 3) | HiSCR50 at week 16 | HiSCR50 achieved by roughly half of bimekizumab-treated patients, significantly above placebo in the pooled Phase 3 program |
Where trials have failed
Drugs that missed their endpoint — and what contributed
The most instructive lessons in hidradenitis suppurativa development come from programmes that failed the endpoint that mattered.
| Drug / trial | Endpoint outcome | What contributed |
|---|---|---|
| Bermekimab (anti-IL-1 alpha) — Phase 2 program in HS (Janssen) | Failed to demonstrate the expected efficacy over placebo, and development in HS was discontinued | IL-1 alpha blockade appeared insufficient as a target in HS; a high placebo response and heterogeneous disease likely contributed to the lack of separation |
Choosing the right endpoint
Primary endpoints that matter in hidradenitis suppurativa trials
- Hidradenitis Suppurativa Clinical Response (HiSCR) — Primary endpoint across HS biologic trials: >=50% reduction in abscess and inflammatory nodule count with no increase in abscesses or draining fistulas
- HiSCR50/75/90 — Graded response thresholds; higher cutoffs (75/90) reflect more stringent skin clearance and were emphasized in bimekizumab trials
- Skin pain (numeric rating scale) — Patient-reported outcome capturing pain, a dominant symptom and key quality-of-life driver in HS
- Flare and abscess/nodule count — Objective lesion counts and flare frequency used to quantify inflammatory disease activity
How iNGENū runs hidradenitis suppurativa trials
Physician-led design, built for FDA submission
Endpoint & biomarker strategy
Board-certified specialists design endpoints and patient selection aligned to current FDA guidance for this indication.
FDA-ready data
Built to ICH-GCP and 21 CFR 312.120, with direct FDA submission — data accepted by the FDA, EMA and MHRA.
Faster, lower-cost delivery
~4-week ethics via the TGA CTN scheme, up to 43.5% R&D rebate, and 80–90% below US CRO cost.
Request a fixed-milestone proposal and a tailored endpoint & feasibility summary for this indication.
Frequently asked questions
Hidradenitis Suppurativa clinical trials — FAQs
What does HiSCR measure and why is it the standard endpoint?
How did treatment options evolve after adalimumab?
Is HS managed with medication alone?
Ready to discuss your hidradenitis suppurativa trial?
Talk to our physician-led team about an FDA-ready, cost-efficient trial design.
Request a proposal