A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT05923099 |
Recruitment Status :
Recruiting
First Posted : June 28, 2023
Last Update Posted : May 1, 2024
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Tracking Information | |||||||||||
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First Submitted Date ICMJE | June 20, 2023 | ||||||||||
First Posted Date ICMJE | June 28, 2023 | ||||||||||
Last Update Posted Date | May 1, 2024 | ||||||||||
Actual Study Start Date ICMJE | September 20, 2023 | ||||||||||
Estimated Primary Completion Date | December 9, 2024 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
Percent change in Eczema Area and Severity Index (EASI) score [ Time Frame: From baseline to Week 16 ] The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe, and/or more extensive condition.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
Change History | |||||||||||
Current Secondary Outcome Measures ICMJE |
Number of treatment-emergent adverse events (TEAEs) recorded for each subject [ Time Frame: From baseline (Week 0) to Week 16 ] | ||||||||||
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 Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis | ||||||||||
Official Title ICMJE | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-site, Parallel-group, Dose-finding Trial to Evaluate the Efficacy and Safety of Different Doses of Subcutaneously Administered LEO 138559 in Adult Subjects With Moderate-to-severe Atopic Dermatitis | ||||||||||
Brief Summary | The purpose of this trial is to test different doses of the trial medicine (LEO 138559) at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses. The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks. The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin. At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life. |
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Detailed Description | Not Provided | ||||||||||
Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Atopic Dermatitis | ||||||||||
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 | Recruiting | ||||||||||
Estimated Enrollment ICMJE |
250 | ||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||
Estimated Study Completion Date ICMJE | March 31, 2025 | ||||||||||
Estimated Primary Completion Date | December 9, 2024 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, Czechia, France, Germany, Hungary, Japan, Poland, Romania, Spain, United Kingdom, United States | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT05923099 | ||||||||||
Other Study ID Numbers ICMJE | LP0145-2240 U1111-1286-0955 ( Other Identifier: World Health Organization (WHO) ) 2022-500777-14-00 ( Other Identifier: European Medicines Agency (EMA) ) |
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Has Data Monitoring Committee | No | ||||||||||
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 | January 2024 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |