Clinical trial NCT06283550: Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Hand Eczema
Keywords: abrocitinib
corticosteroid therapy
eczema
atopic dermatitis
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This randomized, double-blind, placebo-controlled, multicenter, phase 2 study aims to evaluate the efficacy of abrocitinib in 84 adult subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.

Eligibility criteria: Inclusion Criteria:

1. Adult subject, 18 years of age or older, at the time of consent.
2. Subject has a history of moderate to severe CHE for at least 6 months prior to Day 1.
3. Subject has refractory hand eczema
4. Subject has moderate to severe CHE at screening and Day 1, as defined by a hand PGA of 3 or 4.
5. Contraceptive use by women of childbearing potential or their male partners during the study and until ≥ 4 weeks after the last study product administration
6. Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1.
7. Subject is willing to participate and is capable of giving informed consent.
8. Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

Exclusion Criteria:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
2. 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.
3. Subject has active skin infections of the hands.
4. Subject has a history or has current active psoriasis.
5. 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.
6. Subject has a history of skin disease or presence of skin condition.
7. Subject has a history of cancer prior to Day 1.
8. Subject has any clinically significant medical condition (including psychiatric condition) or physical/laboratory/vital signs abnormality.
9. Subject has a current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction.
10. Subject has a current or recent clinically significant viral, bacterial, fungal, or parasitic infection.
11. Subject has a history of clinically significant heart disease.
12. Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots (in the opinion of the investigator).
13. Presence of laboratory abnormalities at the screening visit.
14. Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1.
15. Subject has used any topical treatments that could have an impact on CHE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, topical retinoids, crisaborole, calcineurin inhibitors, ruxolitinib, tars, bleach, bleach baths, antimicrobials, medical devices.
16. Subject has a known hypersensitivity to abrocitinib or its excipients.
17. Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1.

Primary outcomes:
measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)
timeFrame: Week 16
Secondary outcomes:
measure: Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)
timeFrame: Weeks 2, 4 and 12
measure: Reduction from baseline in hand Physician's Global Assessment (PGA)
timeFrame: Weeks 2, 4, 12 and 16
measure: Change from baseline in Hand Eczema Severity Index (HECSI)
timeFrame: Weeks 2, 4, 12 and 16
measure: Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE)
timeFrame: Weeks 2, 4, 12 and 16
measure: Patient Global Assessment (PaGA) measurements
timeFrame: Weeks 2, 4, 12 and 16
measure: Change from baseline in hand Dermatology Life Quality Index (DLQI)
timeFrame: Weeks 2, 4, 12 and 16
measure: Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)
timeFrame: Weeks 2, 4, 12 and 16
measure: Change from baseline in pain Numerical Rating Scale (NRS)
timeFrame: Weeks 2, 4, 12 and 16
measure: Change from baseline in itch Numerical Rating Scale (NRS)
timeFrame: Weeks 2, 4, 12 and 16
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: INNO-6052 Site 12
state: New Brunswick
city: Cobourg
country: Canada
facility: INNO-6052 Site 13
state: Ontario
city: Montréal
country: Canada
facility: INNO-6052 Site 11
state: Quebec
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: