Real-World Evidence: Effectiveness and Safety of Chronic Hand Eczema Treatment With Delgocitinib Cream (REACHED)

May 19, 2026 updated by: LEO Pharma

Prospective, Non-interventional, Multicenter Real-world Evidence Study on Effectiveness and Safety of Treatment of Patients With Moderate to Severe Chronic Hand Eczema With Delgocitinib Cream (20mg/g)

The goal of this non-interventional study is to assess changes in the signs and symptoms of Chronic Hand Eczema (CHE), as well as the safety profile and use of delgocitinib cream in routine clinical practice, over a 52-week observation period.

The main question it aims to answer is:

Does delgocitinib cream show effectiveness in routine clinical practice in adult patients with moderate to severe Chronic Hand Eczema (CHE), as measured by achievement of a modified Physician Global Assessment (mPGA) score of 0 or 1?

The decision to prescribe delgocitinib cream is made by the treating physician, as part of the participant's routine medical care for CHE.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Expected countries to participate includes, but not limited, to Germany, US, Canada, UK, Italy and Spain

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neu-Isenburg, Germany
        • LEO Pharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be selected from hospitals or dermatology clinics (private or public)

Description

Inclusion Criteria:

  • Written informed consent to participate in this study and for collecting and analysing medical data pertinent to the study objectives.
  • Age ≥18 years
  • Patients diagnosed with CHE who are eligible for treatment with delgocitinib cream as per the physician's clinical discretion.

Exclusion Criteria:

  • Currently enrolled in an interventional clinical trial, or have participated in an interventional clinical trial in the past year from the date of enrolment
  • Previous enrolment in this non-interventional study.
  • Previous treatment with delgocitinib cream.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adult patients with moderate to severe CHE treated with delgocitinib cream as routine clinical care
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Physician Global Assessment (mPGA)
Time Frame: The mPGA will be assessed at baseline, at each study visit during the study in accordance with routine clinical practice (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).
The modified physician global assessment (mPGA) scale will be used to assess the CHE severity and progression before and after the topical treatment with delgocitinib. The mPGA scale will be used by the treating physicians to rate the severity of CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
The mPGA will be assessed at baseline, at each study visit during the study in accordance with routine clinical practice (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of delgocitinib cream treatment
Time Frame: The safety and tolerability of delgocititinib will be assessed at baseline, at each study visit during the study (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).
Assess adverse drug reactions and serious adverse events during the conduct of the study.
The safety and tolerability of delgocititinib will be assessed at baseline, at each study visit during the study (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).
Short-term and long-term effectiveness of treatment with delgocitinib cream
Time Frame: The mPGA will be assessed at baseline, at each study visit during the study in accordance with routine clinical practice (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).
The modified physician global assessment (mPGA) scale will be used to assess the CHE severity and progression before and after the topical treatment with delgocitinib. The mPGA scale will be used by the treating physicians to rate the severity of CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
The mPGA will be assessed at baseline, at each study visit during the study in accordance with routine clinical practice (approximately every 8-12 weeks), and at the end-of-study visit (Week 52).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Collaborators

ICON Clinical Research
IQVIA Inc.
Optimapharm
Vivactis M2Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NIS-Delgo-2448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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