Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

Jacob Pontoppidan Thyssen

Status and phase: Enrolling; Phase 4

Conditions: Chronic Hand Eczema

Treatments: Drug: Placebo; Drug: Roflumilast 500 Mcg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05682859

2022-503011-42-00 (Other Identifier)

MC-HE-RO

Details and patient eligibility

About

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.

Full description

This study will investigate the efficacy and safety of roflumilast in adult patients with CHE and it is hypothesized that patients treated with oral roflumilast (500 microgram once daily) will experience an improvement in their moderate-to-severe CHE (measured by hand eczema severity index (HECSI)) and alter the skin microbiome. Secondly, it is hypothesized that patients treated with oral roflumilast will experience improved lung function and weight loss.

This study includes two phases:

Phase 1: 20 patients will receive 500 microgram tablet of roflumilast once daily for 16 weeks while 20 patients will receive placebo once daily for 16 weeks.

Phase 2: All 40 patients from phase 1 will receive 500 microgram tablet of roflumilast once daily for 12 weeks.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Breast feeding
• Blood donation during study
• Allergy to roflumilast or any other PDE-4 inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Roflumilast

Active Comparator group

Description:

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

Treatment:

Drug: Roflumilast 500 Mcg Oral Tablet

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo