A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults with Moderate to Severe Hidradenitis Suppurativa – The CEDAR Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515959-38-00

Acronym

INS1007-231

Enrollment

116

Registered

2025-02-24

Start date

2025-03-06

Completion date

Unknown

Last updated

2025-09-22

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

Conditions

Hidradenitis Suppurativa

Brief summary

Percent change from Baseline in total abscess and inflammatory nodule count (AN count) at Week 16

Detailed description

• Responder status for achieving HiSCR50 and HiSCR75 at Week 16 • Continuous secondary efficacy endpoints will be analyzed in the same fashion as the primary endpoint. For the detailed information on the secondary endpoint, please check the Protocol v1.0,12Jul2024, section 9.6, Secondary Endpoint Analyses

Interventions

DRUGBRENSOCATIB

DRUGThe placebo used the same excipients as that used in IMP without active drug substance. The placebo was developed as film-coated tablet same in size and appearance to the IMP.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from Baseline in total abscess and inflammatory nodule count (AN count) at Week 16	—

Secondary

Measure	Time frame
• Responder status for achieving HiSCR50 and HiSCR75 at Week 16 • Continuous secondary efficacy endpoints will be analyzed in the same fashion as the primary endpoint. For the detailed information on the secondary endpoint, please check the Protocol v1.0,12Jul2024, section 9.6, Secondary Endpoint Analyses	—

Countries

Bulgaria, France, Germany, Greece, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026