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

NCT06283550 | Completed Phase 2 FDA Drug

• 1 other identifier: INNO-6052
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 12

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.

Conditions

Chronic Hand Eczema

Keywords

abrocitinib; corticosteroid therapy; eczema; atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from baseline in hand modified Total Lesion Symptom Score (mTLSS)

  Weeks 2, 4 and 12

• Reduction from baseline in hand Physician's Global Assessment (PGA)

  Weeks 2, 4, 12 and 16

• Change from baseline in Hand Eczema Severity Index (HECSI)

  Weeks 2, 4, 12 and 16

• Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE)

  Weeks 2, 4, 12 and 16

• Patient Global Assessment (PaGA) measurements

  Weeks 2, 4, 12 and 16

Study Arms (3)

Abrocitinib 200 mg

EXPERIMENTAL

Abrocitinib at dose 200 mg will be orally administered once daily for 32 weeks.

Drug: Abrocitinib 200 mg

Abrocitinib 100 mg

EXPERIMENTAL

Abrocitinib at dose 100 mg will be orally administered once daily for 32 weeks.

Drug: Abrocitinib 100 mg

Placebo then abrocitinib

PLACEBO COMPARATOR

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: Abrocitinib 200 mg; Drug: Placebo

Interventions

Abrocitinib 100 mg DRUG

Abrocitinib will be available in 100 mg strength tablet

Also known as: CIBINQO

Abrocitinib 100 mg

Abrocitinib 200 mg DRUG

Abrocitinib will be available in 100 mg strength tablet

Also known as: CIBINQO

Abrocitinib 200 mg; Placebo then abrocitinib

Placebo DRUG

Placebo tablet

Also known as: Inert tablet

Placebo then abrocitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Subject has a current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction.
• Subject has a current or recent clinically significant viral, bacterial, fungal, or parasitic infection.
• Subject has a history of clinically significant heart disease.
• 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).
• Presence of laboratory abnormalities at the screening visit.
• Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1.
• 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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (12)

INNO-6052 Site 12

Fredericton, New Brunswick, E3B 1G9, Canada

Location

INNO-6052 Site 13

Cobourg, Ontario, K9A 0Z4, Canada

Location

INNO-6052 Site 11

Montreal, Quebec, H2X 2V1, Canada

Location

INNO-6052 Site 19

Krakow, Poland

Location

INNO-6052 Site 17

Lodz, Poland

Location

INNO-6052 Site 21

Lublin, Poland

Location

INNO-6052 Site 23

Mikołów, Poland

Location

INNO-6052 Site 18

Osielsko, Poland

Location

INNO-6052 Site 15

Pomorskie, Poland

Location

INNO-6052 Site 20

Szczecin, Poland

Location

INNO-6052 Site 16

Warsaw, Poland

Location

INNO-6052 Site 22

Wroclaw, Poland

Location

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 28, 2024
• Study Start: May 31, 2024
• Primary Completion: June 18, 2025
• Study Completion: November 3, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); PL (9)