Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

NCT05682859 | Recruiting Phase 4

• 2 other identifiers: MC-HE-RO2022-503011-42-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension. The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE). Patients will receive 16-week treatment with either roflumilast or placebo tablets. Hereafter, both groups continue in open-label treatment for 12 weeks where both groups will receive treatment with roflumilast.

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving at least 75% reduction in hand eczema severity index (HECSI75) at week 16 when compared to HECSI at baseline.

  HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.

  Through study completion, an average of 28 weeks

Secondary Outcomes (17)

• Proportion of patients achieving at least 50% reduction in baseline HECSI (HECSI50) at assessments.

  Through study completion, an average of 28 weeks

• Proportion of patients achieving at least 90% reduction in baseline HECSI (HECSI90) at assessments.

  Through study completion, an average of 28 weeks

• Proportion of patients achieving at least 100% reduction in baseline HECSI (HECSI100) at assessments

  Through study completion, an average of 28 weeks

• Percent change from baseline in HECSI score at assessments.

  Through study completion, an average of 28 weeks

• Change (2 or more points) in physician global assessment for chronic hand eczema IGA-CHE) at assessments.

  Through study completion, an average of 28 weeks

Other Outcomes (6)

• Change in lung function between baseline and week 16

  16 weeks

• Change in lung function between baseline and week 16

  16 weeks

• Change in natural moisturizing factor (NMF) between baseline and week 16

  16 weeks

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR

20 of the participating patients are randomized to the active arm where systemic roflumilast 500 microgram tablets are received.

Drug: Roflumilast 500 Mcg Oral Tablet

Placebo

PLACEBO COMPARATOR

20 of the participating patients are randomized to the active arm where systemic placebo tablets are received.

Drug: Placebo

Interventions

Roflumilast 500 Mcg Oral Tablet DRUG

Randomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2.

Also known as: Daxas

Roflumilast

Placebo DRUG

Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Age ≤ 75 years
• HECSI ≥ 18 (moderate to severe hand eczema)
• IGA-CHE ≥ 3
• Body mass index (BMI) ≥ 20 kg/m2
• Negative pregnancy test (only women of child-bearing potential (see section 2.8))
• Willing to use safe anticonception during entire study and at least 1 week after end of treatment (-5 times plasma half-life of Roflumilast). This only account for women child-bearing potential
• Speaks, understands, and reads danish.

You may not qualify if:

• Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
• Diagnosis of current tuberculosis
• Current viral hepatitis
• History of heart failure (NYHA III-IV)
• History of moderate or severe liver failure (Child-Pugh B-C)
• Current or former depression with suicidal ideation
• Topical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomization
• Topical therapy (anti-inflammatory) for chronic hand eczema during study
• Systemic therapy for chronic hand eczema 28 days before randomization
• Systemic therapy for chronic hand eczema during study
• Current treatment with oral dicloxacillin or macrolide
• Current treatment with topical antibiotics
• Diagnosis of contact eczema of clinical significance 3 months before randomization
• Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®)
• Confirmed pregnancy

Sponsors & Collaborators

• Jacob Pontoppidan Thyssen: lead
• The Novo Nordic Foundation: collaborator

Study Sites (1)

Department of dermatology and veneorology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Interventions

Roflumilast; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Jacob P Thyssen, Professor, MD, DMSc

CONTACT

38636173; jacob.pontoppidan.thyssen@regionh.dk

Maria O Christensen, MD

CONTACT

26171989; maria.oberlaender.christensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigators as well as the participating patients are blinded during the RCTs phase 1 of roflumilast/placebo. No one is blinded in phase 2 because it is an open-label extension.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMSc

Model Details: Multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 12, 2023
• Study Start: September 25, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

DK (1)