Adalimumab Treatment for Patients with Hidradenitis Suppurativa at high risk of Progressing to Severe Disease: An Unblinded Randomized, Controlled Trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522505-37-00

Enrollment

100

Registered

2026-08-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis suppurativa

Brief summary

The primary outcome: Development of severe HS over a two-year period Endpoint: Percentage of subjects with non-severe HS at baseline who progress to severe HS at any time from baseline (Week 0) until visit 10 (Week 104) in the Adalimumab arm compared with the SOC arm. For this purpose, severe HS will be defined as having either: 1. Hurley stage 3: Multiple interconnected sinus tracts and nodules/abscesses throughout the affected area. or 2. an IHS4 score ≥11 points

Interventions

DRUGDOXYCYCLINE

DRUGADALIMUMAB

DRUGResorcinol

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary outcome: Development of severe HS over a two-year period Endpoint: Percentage of subjects with non-severe HS at baseline who progress to severe HS at any time from baseline (Week 0) until visit 10 (Week 104) in the Adalimumab arm compared with the SOC arm. For this purpose, severe HS will be defined as having either: 1. Hurley stage 3: Multiple interconnected sinus tracts and nodules/abscesses throughout the affected area. or 2. an IHS4 score ≥11 points	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 25, 2026