Dupilumab in Severe Chronic Hand Eczema

NCT04512339 | Unknown Phase 2

• 1 other identifier: 201900237
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of dupilumab in hand eczema patients with an inadequate response or intolerance to alitretinoin.

Conditions

Hand Eczema

Keywords

Hand eczema; Dupilumab

Outcome Measures

Primary Outcomes (1)

• Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)

  HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). A decrease in score relates to an improvement in signs and symptoms. Response is defined as HECSI-75: the proportion of patients wit a HECSI score of ≥75% improvement from baseline.

  16 weeks

Secondary Outcomes (14)

• Response to treatment/hand eczema severity (Photographic guide)

  Week 4, 8, 12, 16

• Response to treatment/hand eczema/foot eczema severity (Physician Global Assessment)

  Week 4, 8, 12, 16

• Response to treatment/hand eczema/foot eczema severity (modified Total Lesion Symptom Score, mTLSS)

  Week 4, 8, 12, 16

• Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)

  Week 4, 8, 12, 16

• Patient reported change (Patient Global Assessment, PaGA)

  Week 4, 8, 12, 16

Study Arms (2)

Dupilumab

ACTIVE COMPARATOR

Patients with severe hand eczema with an inadequate response or intolerance to alitretinoin. This group will receive dupilumab injections (600mg subcutaneously as a loading dose, followed by 300mg subcutaneously once every two weeks).

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

Patients with severe hand eczema with an inadequate response or intolerance to alitretinoin. This group will receive placebo injections (600mg subcutaneously as a loading dose, followed by 300mg subcutaneously once every two weeks).

Drug: Placebo

Interventions

Dupilumab DRUG

Dupilumab injections (blinded labels)

Also known as: Dupixent

Dupilumab

Placebo DRUG

Placebo injections (blinded labels), matching the dupilumab injections in quantity and appearance

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 and ≤ 75 years.
• Severe or very severe chronic hand eczema as defined by a Physician Global Assessment (PGA) using a validated Photoguide.
• Inflammatory subtypes of hand eczema: recurrent vesicular hand eczema or chronic fissured hand eczema.
• An inadequate response to topical corticosteroids within 6 months before screening.
• A history of prior alitretinoin exposure and inadequate response or intolerance to alitretinoin.
• Patients has also received standard skin care, including emollients and barrier protection as appropriate, without significant improvement.
• Patients has avoided irritants and contact allergens, if identified, without significant improvement.
• Women of childbearing potential are required to use a highly effective (failure rate of \<1% per year when used consistently and correctly) method of birth control, prior to receiving study intervention, during the study and for at least 10 weeks after receiving the last administration of study intervention. E.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant). NOTE: If a female participant's childbearing potential changes after start of the study (e.g., a woman who is not heterosexually active becomes active, a premenarchal woman experiences menarche), she must begin practicing a highly effective method of birth control, as described above.
• A woman of childbearing potential must have a negative serum or urine pregnancy test (β-human chorionic gonadotropin \[β-hCG\]) at screening and at Week 0 prior to administration of study intervention;
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
• Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study intervention.
• Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to participate in the study.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Other clinical subtypes of hand eczema, e.g. hyperkeratotic hand eczema, as defined by the Danish Contact Dermatitis Group24.
• Treatment with alitretinoin, systemic immunosuppressive medication or UV radiation within the previous 4 weeks.
• Psoriasis of the hands.
• Active bacterial, fungal, or viral infection of the hands.
• Pregnant/lactating or planning to become pregnant during the study period.
• Current malignancy (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and⁄or localized carcinoma in situ of the cervix).
• Participant has known allergies, hypersensitivity, or intolerance to dupilumab or its excipients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, acetic acid, sucrose, water for injections.
• Participants with active helminth and other parasitic infections.
• Patients infected with human immunodeficiency virus (HIV) (positive serology for HIV antibody).
• Patients testing positive for hepatitis B virus (HBV) or hepatitis C (HCV) infection.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• Voorberg AN, Kamphuis E, Christoffers WA, Schuttelaar MLA. Efficacy and safety of dupilumab in patients with severe chronic hand eczema with inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled phase IIb proof-of-concept study. Br J Dermatol. 2023 Sep 15;189(4):400-409. doi: 10.1093/bjd/ljad156.

  PMID: 37170922 DERIVED

MeSH Terms

Interventions

dupilumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dermatologist

Model Details: 2:1 randomization. Two-thirds will receive dupilumab injections (loading dose of 600mg subcutaneously followed by 300 mg subcutaneously every 2 weeks). One-third will receive placebo injections.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: August 13, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)