A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema
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ClinicalTrials.gov Identifier: NCT05259722 |
Recruitment Status :
Completed
First Posted : February 28, 2022
Last Update Posted : April 9, 2024
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | February 18, 2022 | ||||||||||||||||
First Posted Date ICMJE | February 28, 2022 | ||||||||||||||||
Last Update Posted Date | April 9, 2024 | ||||||||||||||||
Actual Study Start Date ICMJE | June 15, 2022 | ||||||||||||||||
Actual Primary Completion Date | November 8, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Change in HECSI score from baseline to Week 12 [ Time Frame: 12 weeks ] The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema | ||||||||||||||||
Official Title ICMJE | A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema | ||||||||||||||||
Brief Summary | This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules. |
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Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Hand Eczema | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||
Actual Enrollment ICMJE |
513 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
510 | ||||||||||||||||
Actual Study Completion Date ICMJE | December 5, 2023 | ||||||||||||||||
Actual Primary Completion Date | November 8, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Main inclusion criteria:
Main exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Austria, Canada, France, Germany, Italy, Norway, Poland, Slovakia, Spain, United Kingdom | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT05259722 | ||||||||||||||||
Other Study ID Numbers ICMJE | LP0133-1528 2021-003543-16 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | LEO Pharma | ||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||
Current Study Sponsor ICMJE | LEO Pharma | ||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | LEO Pharma | ||||||||||||||||
Verification Date | April 2024 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |