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Chronic Hand EczemaPhase 2NCT06283550

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

A Phase 2 study testing Abrocitinib 200 mg and Abrocitinib 100 mg in people with Chronic Hand Eczema, run by Innovaderm Research Inc. at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hand Eczema
What is being tested?
Abrocitinib 200 mg and Abrocitinib 100 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
12 sitesin 2 countries
Study dates
31 May 2024to 3 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.
  • Subject has a known hypersensitivity to abrocitinib or its excipients.
  • Subject has a known history of clinically significant drug or alcohol abuse within 6 months prior to Day 1.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Poland9 sites

  • INNO-6052 Site 19

    Krakow

  • INNO-6052 Site 17

    Lodz

  • INNO-6052 Site 21

    Lublin

  • INNO-6052 Site 23

    Mikołów

  • INNO-6052 Site 18

    Osielsko

  • INNO-6052 Site 15

    Pomorskie

  • INNO-6052 Site 20

    Szczecin

  • INNO-6052 Site 16

    Warsaw

  • INNO-6052 Site 22

    Wroclaw

Other trials in Poland

Canada3 sites

  • INNO-6052 Site 13

    Cobourg, Ontario, K9A 0Z4

  • INNO-6052 Site 12

    Fredericton, New Brunswick, E3B 1G9

  • INNO-6052 Site 11

    Montreal, Quebec, H2X 2V1

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Abrocitinib 200 mg, Abrocitinib 100 mg, Placebo
Keywords
abrocitinib, corticosteroid therapy, eczema, atopic dermatitis
Medical subject headings
Eczema, Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abrocitinib 200 mgDrug

    Also called CIBINQO

    Abrocitinib will be available in 100 mg strength tablet

  • Abrocitinib 100 mgDrug

    Also called CIBINQO

    Abrocitinib will be available in 100 mg strength tablet

  • PlaceboDrug

    Also called Inert tablet

    Placebo tablet

Study groups in NCT06283550
Study groupRoleWhat they receive
Abrocitinib 200 mgExperimentalAbrocitinib at dose 200 mg will be orally administered once daily for 32 weeks.
Receives: Drug: Abrocitinib 200 mg
Abrocitinib 100 mgExperimentalAbrocitinib at dose 100 mg will be orally administered once daily for 32 weeks.
Receives: Drug: Abrocitinib 100 mg
Placebo then abrocitinibPlacebo comparatorPlacebo 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).
Receives: Drug: Abrocitinib 200 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Week 16

Secondary outcomes (9)

  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).

    Measured: Weeks 2, 4 and 12

  2. 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).

    Measured: Weeks 2, 4, 12 and 16

  3. 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.

    Measured: Weeks 2, 4, 12 and 16

  4. 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%.

    Measured: Weeks 2, 4, 12 and 16

  5. 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.

    Measured: Weeks 2, 4, 12 and 16

  6. 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.

    Measured: Weeks 2, 4, 12 and 16

  7. 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.

    Measured: Weeks 2, 4, 12 and 16

  8. 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.

    Measured: Weeks 2, 4, 12 and 16

  9. 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.

    Measured: Weeks 2, 4, 12 and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start31 May 2024
  3. Primary completion18 Jun 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06283550
Sponsor's protocol ID
INNO-6052
Status last verified
Jan 2026
First submitted
16 Feb 2024
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abrocitinib 200 mg and Abrocitinib 100 mg in people with Chronic Hand Eczema, run by Innovaderm Research Inc. at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Poland, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06283550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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