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A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa: Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS2)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517633-40-00
Acronym
INCB018424-325
Enrollment
68
Registered
2025-08-05
Start date
2025-09-18
Completion date
Unknown
Last updated
2025-12-09

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 binary response status of HiSCR75 (defined as ≥ 75% reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count) at Week 16.

Detailed description

Additional endpoints for EU–Treatment-IR Population: HiSCR75 at Week 16. The binary response status of ≥ 1 HS flare during the DBVC period. The binary response status of participants with baseline Skin Pain NRS score ≥ 3 who achieve Skin Pain NRS30 at Week 16. More endpoints in protocol.

Interventions

Sponsors

Incyte Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The binary response status of HiSCR75 (defined as ≥ 75% reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count) at Week 16.

Secondary

MeasureTime frame
Additional endpoints for EU–Treatment-IR Population: HiSCR75 at Week 16. The binary response status of ≥ 1 HS flare during the DBVC period. The binary response status of participants with baseline Skin Pain NRS score ≥ 3 who achieve Skin Pain NRS30 at Week 16. More endpoints in protocol.

Countries

Belgium, Bulgaria, France, Germany, Netherlands, Poland, Spain

Outcome results

None listed

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