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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Hand Eczema
• Intervention / Treatment: Drug: Placebo; Drug: Abrocitinib 200 mg; Drug: Abrocitinib 100 mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rosanna Ottoni, BSc; Phone Number: 107 514-521-4285; Email: rottoni@innovaderm.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
      • Contact: Rosanna Ottoni, BSc; Phone Number: 107 514-521-4285; Email: rottoni@innovaderm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abrocitinib 200 mg; Abrocitinib at dose 200 mg will be orally administered once daily for 32 weeks.	Drug: Abrocitinib 200 mg; Abrocitinib will be available in 100 mg strength tablet; Other Names: CIBINQO
Experimental: Abrocitinib 100 mg; Abrocitinib at dose 100 mg will be orally administered once daily for 32 weeks.	Drug: Abrocitinib 100 mg; Abrocitinib will be available in 100 mg strength tablet; Other Names: CIBINQO
Placebo Comparator: Placebo then abrocitinib; Placebo will be orally administered once daily for 16 weeks (Part A) then abrocitinib 200 mg will be orally administered once daily for 16 weeks (Part B).	Drug: Placebo; Placebo tablet; Other Names: Inert tablet; Drug: Abrocitinib 200 mg; Abrocitinib will be available in 100 mg strength tablet; Other Names: CIBINQO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)	The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, oedema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale.These ratings are then added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease).	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Hand Eczema Severity Index (HECSI)	The HECSI scoring system incorporates both the extent and the intensity of the disease. The total sum called the HECSI score will be calculated, varying from 0 to a maximum severity score of 360 points.	Weeks 2, 4, 12 and 16
Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE)	The Extent of Disease will be estimated by the physician as the percentage of hand area (palmar and dorsal) affected by eczema, both hands (both surface) cumulating 100%.	Weeks 2, 4, 12 and 16
Patient Global Assessment (PaGA) measurements	Using the PaGA chart, subjects will be asked by the investigator to grade their overall change from baseline in their CHE by selecting the description which best matches their perception of treatment effect.	Weeks 2, 4, 12 and 16
Change from baseline in hand Dermatology Life Quality Index (DLQI)	The DLQI is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions.	Weeks 2, 4, 12 and 16
Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)	The mTLSS is an assessment of the severity of each of the following: erythema, scaling, lichenification/hyperkeratosis, vesicles, oedema, fissures, and pruritus/pain. Each of these are rated using a 4-point severity scale.These ratings are then added to create a total mTLSS calculated as the sum of assigned individual scores with a maximum value of 21 (most severe disease) and a minimum of 0 (no disease).	Weeks 2, 4 and 12
Reduction from baseline in hand Physician's Global Assessment (PGA)	The PGA is a global assessment of the current state of the disease and will be completed specific to the hands. It is a 5-point scale of overall disease severity by rating the particular signs and symptoms of chronic hand eczema (erythema, scaling, hyperkeratosis/lichenification, vesiculation, oedema, fissures and pruritus/pain).	Weeks 2, 4, 12 and 16
Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)	The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. The QOLHEQ total-score ranges from 0-127 points.	Weeks 2, 4, 12 and 16
Change from baseline in pain Numerical Rating Scale (NRS)	The intensity of pain related to CHE will be recorded using a NRS. Pain intensity will be evaluated by asking subjects to assign a numerical score representing of the worst intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst imaginable symptoms.	Weeks 2, 4, 12 and 16
Change from baseline in itch Numerical Rating Scale (NRS)	The intensity of pruritus associated with CHE will be recorded using an NRS. This will be evaluated by asking subjects to assign a numerical score between 0 and 10 corresponding to their worst itching over the past 24 hours, with 0 indicating no itch and 10 indicating worst imaginable itch.	Weeks 2, 4, 12 and 16

Collaborators and Investigators

• Sponsor: Innovaderm Research Inc.
• Investigators: Principal Investigator: Robert Bissonnette, MD, Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema; abrocitinib; corticosteroid therapy
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abrocitinib
• Other Study ID Numbers: INNO-6052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes