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NCT02400749 · ClinicalTrials.gov registry record · Phase 4
Apremilast in Palmo-Plantar Psoriasis
A Phase 4 study of Palmo-plantar Psoriasis, sponsored by Innovaderm Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 11
- Study locations
NCT02400749 is a Phase 4 study of Palmo-plantar Psoriasis that has completed, run by Innovaderm Research. The registered enrollment target is 100 participants. The trial reports 11 study locations across 6 states.
The verdict
NCT02400749, a Phase 4 study of Palmo-plantar Psoriasis, has completed, sponsored by Innovaderm Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 11
- Study locations
Study Summary
This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects with moderate to severe plaque psoriasis involving palms and/or soles. Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared against placebo (dummy drug with no active ingredient). This study will enroll approximately 100 adult subjects with moderate to severe plaque psoriasis involving palms and/or soles in approximately 20 centers in US and Canada. To be eligible, subjects must have moderate to severe plaque psoriasis involving palms or soles, with lesions covering at least 10% of the surface of palms and soles at the baseline visit. Study treatments will be assigned randomly (like flipping a coin) at a 1:1 ratio, meaning that there will be a 1 in 2 chance of either receiving Apremilast or placebo during the first 16 weeks. Subjects will not know which of the two treatments they receive. The study doctor, the study staff will not know which treatment they receive either. All subjects will receive Apremilast from Week 16 to Week 32. Subjects will be asked to complete questionnaires about their hand and feet pain, their quality of life, their general health and the impact of psoriasis on their work. Medical photographs of palms and soles will be taken for subjects at selected study sites only. At Baseline and Week 16 visits, for willing subjects at certain study sites, skin biopsies can be taken. The biopsies will be analyzed for the presence of antibodies, antigens or certain cellular messengers that can be quantified. It is also possible to study the skin cellular structure and organization. A total of 3 biopsies will be taken: At Baseline visit, one biopsy from psoriasis on palms or soles and one biopsy from normal skin of palms or soles will be collected. At Week 16 visit, only one biopsy from psoriasis on palms or soles will be collected.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Apremilast
Study Locations (11)
Ontario
- Innovaderm Investigational Site - Barrie
- Innovaderm Investigational Site - Markham
- Innovaderm Investigational Site - North Bay
- Innovaderm Investigational Site - Peterborough
Quebec
- Innovaderm Investigational Site - Drummondville
- Innovaderm Investigational Site - Montreal
- Innovaderm Investigational Site - Saint-Jérôme
Illinois
- Innovaderm Investigational Site - Arlington Heights
Alberta
- Innovaderm Investigational Site - Calgary
Newfoundland and Labrador
- Innovaderm Investigational Site - St. John's
Other
- Innovaderm Investigational Site - Québec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-11 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02400749
The ClinicalTrials.gov registry entry for NCT02400749 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Innovaderm Research, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Palmo-plantar Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02400749 reports 11 study locations spanning 6 distinct geographic areas - top geographies include Ontario, Quebec, Illinois.
Frequently Asked Questions
What is clinical trial NCT02400749 about?
NCT02400749 is a clinical study titled "Apremilast in Palmo-Plantar Psoriasis". This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects with moderate to severe plaque psoriasis involving palms and/or soles. Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared against placebo (dummy drug with no active ing...
What is the current status of trial NCT02400749?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2015-05. Estimated completion is 2016-11.
What conditions does trial NCT02400749 study?
This clinical trial studies the following conditions: Palmo-plantar Psoriasis.
What interventions are being tested in trial NCT02400749?
The interventions under investigation include: Placebo (DRUG), Apremilast (DRUG).
Who is sponsoring clinical trial NCT02400749?
This trial is sponsored by Innovaderm Research, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02400749 being conducted?
This trial has 11 study locations across Illinois, Alberta, Newfoundland and Labrador, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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