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NCT01384630 · ClinicalTrials.gov registry record · Phase 2
Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01384630 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 8 participants.
The verdict
NCT01384630, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the end of the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.
Interventions
- DRUG RA-18C3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-09-30 |
| Est. Completion | 2012-08-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01384630
The ClinicalTrials.gov registry entry for NCT01384630 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RA-18C3 is the first listed.
NCT01384630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01384630 about?
NCT01384630 is a clinical study titled "Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis". This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injecti...
What is the current status of trial NCT01384630?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2011-09-30. Estimated completion is 2012-08-31.
What interventions are being tested in trial NCT01384630?
The interventions under investigation include: RA-18C3 (DRUG).
Who is sponsoring clinical trial NCT01384630?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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