← Back to Search

Corticosteroid

Abrocitinib for Chronic Hand Eczema

Phase 2

Recruiting

Led By Robert Bissonnette, MD

Research Sponsored by Innovaderm Research Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult subject, 18 years of age or older, at the time of consent

Female subject of childbearing potential has had a negative serum pregnancy test at screening and negative urine pregnancy test on Day 1

Must not have

Subject has a history of cancer prior to Day 1

Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 2, 4, 12 and 16

Summary

This trial will test a new drug called abrocitinib to see if it is safe and effective for treating chronic hand eczema. Researchers will also look at how well the drug is tolerated by

Who is the study for?

This trial is for people with moderate to severe chronic hand eczema that hasn't improved with corticosteroid treatments. Participants should have a stable condition and not be planning to change their usual medication routines during the trial.

What is being tested?

The study tests abrocitinib, an oral medication, at two different doses (100 mg and 200 mg) compared to a placebo. It measures how well the drug works, its safety, and how tolerable it is for patients with hand eczema.

What are the potential side effects?

Abrocitinib may cause side effects like nausea, headache, common cold symptoms or infections. There might also be skin reactions at the pill-taking site or issues related to changes in blood test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am a woman who can have children and have had negative pregnancy tests.

Select...

I have had severe hand eczema for at least 6 months.

Select...

My hand eczema has not improved with treatment.

Select...

My hand eczema is moderate to severe, as confirmed by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had cancer before.

Select...

I haven't taken any experimental or approved biological drugs recently.

Select...

I have an active skin infection on my hands.

Select...

I have had eczema herpeticum recently or multiple times before.

Select...

I have a history of blood clotting or platelet issues.

Select...

I currently have, or recently had, a serious infection.

Select...

I have or have had psoriasis.

Select...

I have a history of serious heart problems.

Select...

I am currently breastfeeding, pregnant, or planning to become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 2, 4, 12 and 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 2, 4, 12 and 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 4, 12 and 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Change from baseline in Hand Eczema Severity Index (HECSI)

Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Abrocitinib 200 mgExperimental Treatment1 Intervention

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

Group II: Abrocitinib 100 mgExperimental Treatment1 Intervention

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

Group III: Placebo then abrocitinibPlacebo Group2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abrocitinib 100 mg

2022

Completed Phase 3

~200

Abrocitinib 200 mg

2022

Completed Phase 3

~930