A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Abrocitinib in Subjects with Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

Conditions

Moderate to severe chronic hand eczema

Brief summary

Percent change from baseline in hand mTLSS at Week 16

Detailed description

Percent change from baseline in hand mTLSS at Weeks 2, 4, and 12, Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in hand PGA at Weeks 2, 4, 12, and 16, Proportion of subjects achieving at least a 2-grade reduction from baseline in hand PGA at Weeks 2, 4, 12, and 16, Percent change from baseline in HESCI at Weeks 2, 4, 12, and 16, Percent change from baseline in Extent of Disease affected with moderate to severe CHE at Weeks 2, 4, 12 and 16., Actual PaGA measeruments at Weeks 2, 4, 12 and 16, Percent change from baseline in hand DLQI at Weeks 2, 4, 12 and 16, Percent change from baseline in QOLHEQ at Weeks 2, 4, 12 and 16, Percent change from baseline in pain NRS at Weeks 2, 4, 12 and 16, Percent change from baseline in itch NRS at Weeks 2, 4, 12 and 16, Number of TEAEs, Number of treatment-related TEAEs, Vital signs and safety laboratory tests

Related papers

No related papers found yet.

Interventions

DRUGCibinqo 100 mg film-coated tablets

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in hand mTLSS at Week 16	—

Secondary

Measure	Time frame
Percent change from baseline in hand mTLSS at Weeks 2, 4, and 12, Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in hand PGA at Weeks 2, 4, 12, and 16, Proportion of subjects achieving at least a 2-grade reduction from baseline in hand PGA at Weeks 2, 4, 12, and 16, Percent change from baseline in HESCI at Weeks 2, 4, 12, and 16, Percent change from baseline in Extent of Disease affected with moderate to severe CHE at Weeks 2, 4, 12 and 16., Actual PaGA measeruments at Weeks 2, 4, 12 and 16, Percent change from baseline in hand DLQI at Weeks 2, 4, 12 and 16, Percent change from baseline in QOLHEQ at Weeks 2, 4, 12 and 16, Percent change from baseline in pain NRS at Weeks 2, 4, 12 and 16, Percent change from baseline in itch NRS at Weeks 2, 4, 12 and 16, Number of TEAEs, Number of treatment-related TEAEs, Vital signs and safety laboratory tests	—

Measure

Time frame

Percent change from baseline in hand mTLSS at Weeks 2, 4, and 12, Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in hand PGA at Weeks 2, 4, 12, and 16, Proportion of subjects achieving at least a 2-grade reduction from baseline in hand PGA at Weeks 2, 4, 12, and 16, Percent change from baseline in HESCI at Weeks 2, 4, 12, and 16, Percent change from baseline in Extent of Disease affected with moderate to severe CHE at Weeks 2, 4, 12 and 16., Actual PaGA measeruments at Weeks 2, 4, 12 and 16, Percent change from baseline in hand DLQI at Weeks 2, 4, 12 and 16, Percent change from baseline in QOLHEQ at Weeks 2, 4, 12 and 16, Percent change from baseline in pain NRS at Weeks 2, 4, 12 and 16, Percent change from baseline in itch NRS at Weeks 2, 4, 12 and 16, Number of TEAEs, Number of treatment-related TEAEs, Vital signs and safety laboratory tests

—

Countries

Poland

Outcome results

None listed