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NCT03442088 · ClinicalTrials.gov registry record · Phase 2
Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast
A Phase 2 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT03442088: Completed Phase 2 study, sponsored by University Hospitals Cleveland Medical Center.
NCT03442088 is a Phase 2 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03442088, a Phase 2 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is an open label pilot study of the impact of treatment with standard dosing of Otezla for 16 weeks on AM-endotype psoriasis patients, identified by elevated (\>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.) circulating monocyte-platelet aggregates (MPA). Approximately 25 psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 4 monthly individual blood draws will be enrolled. All treated psoriasis subjects will receive apremilast through Week 16.
Primary Outcome
For each subject, we will identify a target biomarker of abnormally elevated monocytes, among 1.) intermediate, or 2.) doublets, or 3.) platelet doubles. Each subject will thus have one identified monocyte biomarker for which relative percent change will be its basis for analysis in the primary outcome measure. We will specifically assess change from baseline to 16 weeks by computing relative percent reduction for each subject being treated. Note for example that a change of 1.5% to 1.2% is (1 -
Interventions
- DRUG Apremilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 2 |
What the finished NCT03442088 record still lists
NCT03442088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Apremilast is the first listed.
NCT03442088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03442088 about?
NCT03442088 is a clinical study titled "Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast". This is an open label pilot study of the impact of treatment with standard dosing of Otezla for 16 weeks on AM-endotype psoriasis patients, identified by elevated (\>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.) circulating monocyte-platelet ...
What is the current status of trial NCT03442088?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2018-06-01. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT03442088?
The interventions under investigation include: Apremilast (DRUG).
Who is sponsoring clinical trial NCT03442088?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03442088's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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