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A Phase 2, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502827-23-00
Acronym
INCB 18424-226
Enrollment
51
Registered
2023-09-11
Start date
2023-10-12
Completion date
2024-12-13
Last updated
2024-06-07

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

Conditions

Chronic Hand Eczema

Brief summary

Proportion of participants achieving IGA-CHE-TS at Week 16.

Detailed description

Proportion of participants achieving ITCH4 response at Week 16, Proportion of participants achieving ITCH4 response at Week 4, Proportion of participants achieving ITCH4 response at Week 1 (Day 7)., Proportion of participants achieving IGA-CHE-TS at each postbaseline visit., Proportion of participants achieving ITCH4 response at Day 3., Change from baseline in CHE-related Itch NRS score at each postbaseline visit., Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score., Change from baseline in CHE-related Skin Pain NRS score at each postbaseline visit., Proportion of participants achieving ≥ 2-point improvement in CHE related Skin Pain NRS score from baseline to Week 16., Time to ≥ 2-point improvement from baseline in CHE-related Skin Pain NRS score., Percentage change in HECSI from baseline to Week 16., PGIC score at each postbaseline visit., Change from baseline in DLQI score at Weeks 2, 4, 8, 12, 16, 24, and 32., Change from baseline in EQ-5D-5L score at Weeks 2, 4, 8, 12, 16, 24, and 32., Change from baseline in QOLHEQ score at Weeks 2, 4, 8, 12, 16, 24, 32, and follow-up., Change from baseline in WPAI-ChHD score at Weeks 2, 4, 8, 12, 16, 24, 32, and follow-up., The type, frequency, and severity of AEs as well as changes in vital signs and laboratory data for hematology and serum chemistry.

Interventions

Sponsors

Incyte Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants achieving IGA-CHE-TS at Week 16.

Secondary

MeasureTime frame
Proportion of participants achieving ITCH4 response at Week 16, Proportion of participants achieving ITCH4 response at Week 4, Proportion of participants achieving ITCH4 response at Week 1 (Day 7)., Proportion of participants achieving IGA-CHE-TS at each postbaseline visit., Proportion of participants achieving ITCH4 response at Day 3., Change from baseline in CHE-related Itch NRS score at each postbaseline visit., Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score., Change from baseline in CHE-related Skin Pain NRS score at each postbaseline visit., Proportion of participants achieving ≥ 2-point improvement in CHE related Skin Pain NRS score from baseline to Week 16., Time to ≥ 2-point improvement from baseline in CHE-related Skin Pain NRS score., Percentage change in HECSI from baseline to Week 16., PGIC score at each postbaseline visit., Change from baseline in DLQI score at Weeks 2, 4, 8, 12, 16, 24, and 32., Change from baseline in EQ-5D-5L score at Weeks 2,

Countries

Germany, Poland

Outcome results

None listed

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