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NCT00678470 · ClinicalTrials.gov registry record · NA

Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis

A NA study of Moderate to Severe Psoriasis, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
18
Enrollment target
1
Study location

NCT00678470: Completed NA study of Moderate to Severe Psoriasis, sponsored by University of California, San Francisco.

NCT00678470 is a NA study of Moderate to Severe Psoriasis that has completed, run by University of California, San Francisco. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00678470, a NA study of Moderate to Severe Psoriasis, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. One lesion with a psoriasis severity assessment score greater than 3 and an induration score greater than 1 will be identified on each patient. Each lesion will receive only one intralesional alefacept injection during the first three weeks of the study (1 lesion per week). Following a 2 week observation period, subjects will undergo a standard 12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept treatments. An 8 week follow-up period will begin after the last dose of alefacept is administered where safety and efficacy measures will continue to be monitored as outlined in the study procedures. The hypothesis is that the response to intralesional alefacept injections, whether it is positive or no benefit, will predict the clinical response to intramuscular alefacept administration.

Primary Outcome

Target plaque assessment completed using local Physician's Global Assessment score (PGA). Systemic response measured by comparing Psoriasis Area and Severity Index score at week 22 compared to baseline. Correlation measured using Fisher's non parametric test of association.

Interventions

  • DRUG Intralesional Alefacept

Study Locations (1)

California

  • UCSF Psoriasis and Skin Treatment Center - San Francisco

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2007-09
Est. Completion 2011-06
Phase NA

What the finished NCT00678470 record still lists

NCT00678470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Moderate to Severe Psoriasis appearing as the primary indexed condition, and to 1 intervention - of which Intralesional Alefacept is the first listed.

NCT00678470 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT00678470 about?

NCT00678470 is a clinical study titled "Open Label Study of Alefacept Injections to Patients With Moderate to Severe Psoriasis". This is a single-center, open-label, pilot study. A total of 18 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. O...

What is the current status of trial NCT00678470?

This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2007-09. Estimated completion is 2011-06.

What conditions does trial NCT00678470 study?

This clinical trial studies the following conditions: Moderate to Severe Psoriasis.

What interventions are being tested in trial NCT00678470?

The interventions under investigation include: Intralesional Alefacept (DRUG).

Who is sponsoring clinical trial NCT00678470?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00678470 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00678470's enrollment target sits among peer trials

18 1863rd of 2000 higher than 130 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT00678470, the US trial registry maintained by the National Library of Medicine. NCT00678470 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.