Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Han… (NCT06283550) | Clinical Trial Compass
CompletedPhase 2
Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy
Canada, Poland82 participantsStarted 2024-05-31
Plain-language summary
This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult subject, 18 years of age or older, at the time of consent.
✓. Subject has a history of moderate to severe CHE for at least 6 months prior to Day 1.
✓. Subject has refractory hand eczema
✓. Subject has moderate to severe CHE at screening and Day 1, as defined by a hand PGA of 3 or 4.
✓. Contraceptive use by women of childbearing potential or their male partners during the study and until ≥ 4 weeks after the last study product administration
✓. Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1.
✓. Subject is willing to participate and is capable of giving informed consent.
✓. Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
Exclusion criteria
✕. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
✕. Subject has known or suspected allergic contact dermatitis of the hands and is unable to avoid exposure to the causative allergen or subjects with suspected or expected changes in irritant or allergen exposures from screening through the end of the study.
✕. Subject has active skin infections of the hands.
What they're measuring
1
Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)
. Subject has a history or has current active psoriasis.
✕. Subject has a history of eczema herpeticum within 12 months prior to screening, and/or a history of 2 or more episodes of eczema herpeticum in the past.
✕. Subject has a history of skin disease or presence of skin condition.
✕. Subject has a history of cancer prior to Day 1.
✕. Subject has any clinically significant medical condition (including psychiatric condition) or physical/laboratory/vital signs abnormality.