Completed

Abrocitinib's Efficacy and Safety in Moderate to Severe Chronic Hand Eczema

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Study Aim

This study aims to evaluate the safety and effectiveness of Abrocitinib in treating moderate to severe chronic hand eczema, by observing changes in hand modified Total Lesion Symptom Score (mTLSS), which includes assessing the severity of erythema, scaling, lichenification/hyperkeratosis, vesicles, oedema, fissures, and pruritus/pain.

What is being tested

Abrocitinib 200 mg

+ Placebo

+ Abrocitinib 100 mg

Drug
Who is being recruted

Dermatitis+9

+ Dermatitis, Atopic

+ Eczema

Over 18 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorInnovaderm Research Inc.
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 31, 2024

Actual date on which the first participant was enrolled.

This clinical trial focuses on understanding how effective and safe the drug abrocitinib is for adults suffering from moderate to severe chronic hand eczema, a condition where the skin on the hands becomes red, itchy, and inflamed. Participants in this study have already tried using corticosteroid treatments without success. The study's goal is to find a new, effective treatment option for these individuals, potentially leading to better management of their symptoms and an improved quality of life. Participants in the study will be randomly assigned to receive either abrocitinib or a placebo, with neither the participants nor the researchers knowing who receives which treatment, a process known as double-blind. The drug is administered to see its effects on eczema and is evaluated using a technique called tape stripping, which is a gentle way to collect skin samples for analysis. By comparing the outcomes between the abrocitinib group and the placebo group, the study aims to measure the drug's effectiveness and safety, offering insights into its potential as a new treatment for chronic hand eczema.

Official TitleA 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
NCT06283550
Principal SponsorInnovaderm Research Inc.
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

82 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicEczemaHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

8 inclusion criteria required to participate
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.
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17 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
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).

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Suspended

INNO-6052 Site 19

Krakow, PolandOpen INNO-6052 Site 19 in Google Maps
Suspended

INNO-6052 Site 20

Szczecin, Poland
Suspended

INNO-6052 Site 16

Warsaw, Poland
Suspended

INNO-6052 Site 22

Wroclaw, Poland
Completed12 Study Centers