Hand EczemaPhase 2DUPSHENCT04512339
Dupilumab in Severe Chronic Hand Eczema
A Phase 2 study testing Dupilumab in people with Hand Eczema, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hand Eczema
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2020to Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- Patients with predominantly atopic dermatitis, in whom the hands are also involved, but no main concern. Patients with controlled atopic dermatitis, in which the hands are mainly affected, are eligible for inclusion.
- Psoriasis of the hands.
- Active bacterial, fungal, or viral infection of the hands.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dupilumab in Severe Chronic Hand Eczema With Inadequate Response or Intolerance to Alitretinoin
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
- Being tested
- Dupilumab, Placebo
- Keywords
- Hand eczema, Dupilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
Dupilumab injections (blinded labels)
PlaceboDrug
Placebo injections (blinded labels), matching the dupilumab injections in quantity and appearance
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (14)
Response to treatment/hand eczema severity (Photographic guide)
The photographic guide is a five-point scale that provides a global clinical assessment of hand eczema severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is moderate, 4 is severe; and 5 indicates very severe hand eczema. A decrease in score relates to an improvement in signs and symptoms.
Measured: Week 4, 8, 12, 16
Response to treatment/hand eczema/foot eczema severity (Physician Global Assessment)
A decrease in score relates to an improvement in signs and symptoms.
Measured: Week 4, 8, 12, 16
Response to treatment/hand eczema/foot eczema severity (modified Total Lesion Symptom Score, mTLSS)
mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).
Measured: Week 4, 8, 12, 16
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.
Measured: Week 4, 8, 12, 16
Patient reported change (Patient Global Assessment, PaGA)
Percentage of change of hand eczema symptoms assessed by PaGA. 0 indicates clear or almost clear (at least 90% clearing of disease signs and symptoms compared to baseline), 5 means worsening of symptoms compared to baseline.
Measured: Week 4, 8, 12, 16
Changeof pruritus (Numerical Rating Scale, NRS)
Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus, both maximum and average intensity, during a 24-hour recall period. Maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Measured: Week 4, 8, 12, 16
Change of pain (Numerical Rating Scale, NRS)
Pain NRS is an assessment tool that is used to report the intensity of a patient's pain, both maximum and average intensity, during a 24-hour recall period. Maximum pain intensity on a scale of 0 - 10 (0 = no pain; 10 = worst pain imaginable).
Measured: Week 4, 8, 12, 16
Change of hand eczema related quality of life (Quality of Life in Hand Eczema Questionnaire, QOLHEQ)
The Quality Of Life in Hand Eczema Questionnaire (QOLHEQ) is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The construct HRQOL includes all impairments or limiting conditions caused by the health state of an individual. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists out of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention. A high score is indicative of a poor hand eczema related HRQOL.
Measured: Week 4, 8, 12, 16
Changeof quality of life (Dermatology Life Quality Index, DLQI)
DLQI is a 10-item, validated questionnaire to assess the impact of skin disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (disease has no effect on patient's life) to 30 (disease has an extremely large effect on patient's life); a high score is indicative of a poor QoL.
Measured: Week 4, 8, 12, 16
Change of work productivity and impairment (Work Productivity and Activity Impairment, WPAI)
The WPAI consists of 6 items, assessing absenteeism, presenteeism, work productivity loss and activity impairment. Higher scores indicate less productivity and a greater impairment.
Measured: Week 4, 8, 12, 16
Change of anxiety and depression (Hospital Anxiety and Depression scale, HADS)
HADS is a 14-item questionnaire, 7 items for anxiety and 7 items for depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Measured: Week 4, 8, 12, 16
Cost-utility. Quality-adjusted life-years (QALY's): registered direct/indirect costs, combined with EQ-5D-5L outcome
Measured: Week 4, 8, 12, 16
Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (HECSI and PG)
Measured: Week 4, 8, 12, 16
Safety and tolerability (adverse events)
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Aug 2020
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand EczemaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, Marie Louise A Schuttelaar, MD, PhD, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512339
- Sponsor's protocol ID
- 201900237
- Acronym
- DUPSHE
- Status last verified
- Aug 2022
- First submitted
- 12 Jun 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published anonymously and will not be possible to trace back to individual participants.
Publications
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.
PubMed 37170922
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab in Severe Chronic Hand Eczema With Inadequate Response or Intolerance to Alitretinoin
- ClinicalTrials.gov ID
- NCT04512339
- Acronym / sponsor ID
- DUPSHE / 201900237
- Conditions
- Hand Eczema
- Keywords
- Hand eczema, Dupilumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of dupilumab in hand eczema patients with an inadequate response or intolerance to alitretinoin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Active comparator | Drug: DupilumabPatients 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). |
| Placebo | Placebo comparator | Drug: PlaceboPatients 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- Patients with predominantly atopic dermatitis, in whom the hands are also involved, but no main concern. Patients with controlled atopic dermatitis, in which the hands are mainly affected, are eligible for inclusion.
- Psoriasis of the hands.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentDupilumab injections (blinded labels) | Drug | Dupilumab |
| PlaceboPlacebo injections (blinded labels), matching the dupilumab injections in quantity and appearance | Drug | Placebo |
Primary outcome
Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
Time frame: 16 weeks
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.
14 secondary outcomes
Response to treatment/hand eczema severity (Photographic guide)
Time frame: Week 4, 8, 12, 16
Response to treatment/hand eczema/foot eczema severity (Physician Global Assessment)
Time frame: Week 4, 8, 12, 16
Response to treatment/hand eczema/foot eczema severity (modified Total Lesion Symptom Score, mTLSS)
Time frame: Week 4, 8, 12, 16
Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
Time frame: Week 4, 8, 12, 16
Patient reported change (Patient Global Assessment, PaGA)
Time frame: Week 4, 8, 12, 16
Changeof pruritus (Numerical Rating Scale, NRS)
Time frame: Week 4, 8, 12, 16
Change of pain (Numerical Rating Scale, NRS)
Time frame: Week 4, 8, 12, 16
Change of hand eczema related quality of life (Quality of Life in Hand Eczema Questionnaire, QOLHEQ)
Time frame: Week 4, 8, 12, 16
Changeof quality of life (Dermatology Life Quality Index, DLQI)
Time frame: Week 4, 8, 12, 16
Change of work productivity and impairment (Work Productivity and Activity Impairment, WPAI)
Time frame: Week 4, 8, 12, 16
Change of anxiety and depression (Hospital Anxiety and Depression scale, HADS)
Time frame: Week 4, 8, 12, 16
Cost-utility. Quality-adjusted life-years (QALY's): registered direct/indirect costs, combined with EQ-5D-5L outcome
Time frame: Week 4, 8, 12, 16
Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (HECSI and PG)
Time frame: Week 4, 8, 12, 16
Safety and tolerability (adverse events)
Time frame: Up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Derived from this study: PubMed 37170922Voorberg 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.
- Individual participant dataSharing planned: No. Data will be published anonymously and will not be possible to trace back to individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Hand Eczema, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.