Treatment of Chronic Hand Eczema with Oral Roflumilast (HERO)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bispebjerg Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

25 Sep 2023 → 17 Jun 2025

Decision date (initial)

2023-03-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE).

Conditions and MedDRA coding

Chronic hand eczema

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age ≥ 18 years
2. Age ≤ 75 years
3. HECSI ≥ 18 (moderate to severe hand eczema)
4. IGA-CHE ≥ 3
5. Body mass index (BMI) ≥ 20 kg/m2
6. Negative pregnancy test (only women of child-bearing potential (see section 2.8))
7. 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
8. Speaks, understands, and reads danish

Exclusion criteria 16

1. Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
2. Diagnosis of current tuberculosis
3. Current viral hepatitis
4. History of heart failure (NYHA III-IV)
5. History of moderate or severe liver failure (Child-Pugh B-C)
6. Current or former depression with suicidal ideation
7. Topical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomization (wash-out period) and during study after week 4
8. Systemic therapy for chronic hand eczema 28 days before randomization (wash-out period) and during study
9. Current treatment with oral dicloxacillin or macrolide at screening
10. Current treatment with topical antibiotics at screening
11. Diagnosis of contact eczema of clinical significance 3 months before randomization
12. Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®)
13. Confirmed pregnancy
14. Breast feeding
15. Blood donation during study
16. Allergy to roflumilast or any other PDE-4 inhibitor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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. 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.

Secondary endpoints 14

1. Proportion of patients achieving at least 50% reduction in baseline HECSI (HECSI50) at assessments
2. Proportion of patients achieving at least 90% reduction in baseline HECSI (HECSI90) at assessments
3. Proportion of patients achieving at least 100% reduction in baseline HECSI (HECSI100) at assessments
4. Percent change from baseline in HECSI score at assessments
5. Change (2 or more points) in physician global assessment for chronic hand eczema IGA-CHE) at assessments. The IGA-CHE rates the severity of the patient’s global disease assessed by the physician and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
6. Change from baseline in quality of life hand eczema questionnaire (QOLHEQ) at assessments. QOLHEQ is a validated, self-administered 30-question questionnaire that measures impairment of health-related quality of life (HRQoL) in patients with HE. . Each question is answered on a scale of 0 (not at all) to 4 (all the time) and the total score may vary from 0 to 120. A QOLHEQ score greater than 86 is indicative of very strong impairment.
7. Change from baseline in dermatology life quality index (DLQI) at assessments. DLQI is a validated, self-administered, 10-item questionnaire that measure the impact of skin disease on patients’ quality of life, based on recall over the past week. Domains include symptoms, feeling, daily activities, social, leisure, work or studying, personal relationships, and treatment. Each question is answered on a scale of 0 (not at all) to 3 (very much) and the total score may vary from 0 to 30.
8. Change from baseline in patient’s global assessment (PaGA) at assessments. The PaGA rates the severity of the patient’s global disease assessed by the patient and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
9. Change from baseline in numeric rating scale (NRS) – Peak skin pain on hands within the last 24 hours and 7 days at assessments. NRS is a simple and commonly used numeric scale in which the patient rates patientive symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
10. Change from baseline in NRS – Peak itch on hands within the last 24 hours and 7 days at assessments.
11. Change from baseline in NRS – sleeplessness within the last 24 hours and 7 days at assessments.
12. Change from baseline in NRS – patient treatment satisfaction within the last 7 days at assessments.
13. Change from baseline in work productivity and activity impairment: CHE (WPAI:CHE) at assessments. WPAI is a validated, self-administered questionnaire that measures the impact of CHE on work. Domains include time missed from work and impairment of work and regular activities due to CHE.
14. Adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARS) documented at assessments.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bispebjerg Hospital

Sponsor organisation

Bispebjerg Hospital

Address

Borgmester Ib Juuls Vej 31

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Bispebjerg Hospital

Contact name

Maria Oberländer Christensen

Public contact point

Organisation

Bispebjerg Hospital

Contact name

Maria Oberländer Christensen

Third parties 1

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications