A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523259-72-00

Enrollment

195

Registered

2026-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-21

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

Conditions

Hidradenitis Suppurativa (HS)

Brief summary

Occurrence of treatment-emergent Adverse Events (TEAEs)

Detailed description

• Achievement of AN50/75/90. • Percentage change from baseline in IHS4 • Achievement of HiSCR50/75/90. • Achievement of NRS30 among participants with baseline NRS ≥ 3 (in the main studies).

Interventions

DRUGPlacebo to Remibrutinib (LOU064) XX mg film-coated tablet

DRUGLOU064

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of treatment-emergent Adverse Events (TEAEs)	—

Secondary

Measure	Time frame
• Achievement of AN50/75/90. • Percentage change from baseline in IHS4 • Achievement of HiSCR50/75/90. • Achievement of NRS30 among participants with baseline NRS ≥ 3 (in the main studies).	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 22, 2026