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NCT01261767 · ClinicalTrials.gov registry record · Phase 1
First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects
A Phase 1 study, sponsored by Novo Nordisk A/S.
- Terminated
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01261767 is a Phase 1 study that was terminated before completion, run by Novo Nordisk A/S. The registered enrollment target is 55 participants.
The verdict
NCT01261767, a Phase 1 study, was terminated before completion, sponsored by Novo Nordisk A/S.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial. This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks. Initiation of the MD expansion phase will depend on results from the SD and MD dose-escalation phases and only if an acceptable safety profile is present. Subjects participating in the expansion phase are not allowed to have participated in the previous phases (SD and MD dose-escalation phases) of the trial.
Interventions
- DRUG placebo
- DRUG anti-IL-20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01261767
The ClinicalTrials.gov registry entry for NCT01261767 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01261767 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01261767 about?
NCT01261767 is a clinical study titled "First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects". This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial. This trial consists of 3 parts: A single dose...
What is the current status of trial NCT01261767?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2008-04. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01261767?
The interventions under investigation include: placebo (DRUG), anti-IL-20 (DRUG).
Who is sponsoring clinical trial NCT01261767?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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