Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

Last updated: April 14, 2025
Sponsor: Innovaderm Research Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Skin Wounds

Rash

Allergies & Asthma

Treatment

Placebo

Abrocitinib 200 mg

Abrocitinib 100 mg

Clinical Study ID

NCT06283550
INNO-6052
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

  3. Subject has refractory hand eczema

  4. Subject has moderate to severe CHE at screening and Day 1, as defined by a hand PGAof 3 or 4.

  5. Contraceptive use by women of childbearing potential or their male partners duringthe study and until ≥ 4 weeks after the last study product administration

  6. Female subject of childbearing potential has had a negative serum pregnancy test atscreening 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 availablefor the duration of the study.

Exclusion

Exclusion Criteria:

  1. Subject is a female who is breastfeeding, pregnant, or who is planning to becomepregnant during the study.

  2. Subject has known or suspected allergic contact dermatitis of the hands and isunable to avoid exposure to the causative allergen or subjects with suspected orexpected changes in irritant or allergen exposures from screening through the end ofthe 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 psychiatriccondition) or physical/laboratory/vital signs abnormality.

  9. Subject has a current or past medical history of conditions associated withthrombocytopenia, coagulopathy, or platelet dysfunction.

  10. Subject has a current or recent clinically significant viral, bacterial, fungal, orparasitic 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 clinicallysignificant heart problems, stroke, or blood clots (in the opinion of theinvestigator).

  13. Presence of laboratory abnormalities at the screening visit.

  14. Subject has received any marketed or investigational biological agent within 12weeks 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 2weeks 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 6months prior to Day 1.

Study Design

Total Participants: 84
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 31, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • INNO-6052 Site 12

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • INNO-6052 Site 13

    Cobourg, Ontario K9A 0Z4
    Canada

    Site Not Available

  • INNO-6052 Site 11

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Innovaderm Research Inc.

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

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