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NCT00708916 · ClinicalTrials.gov registry record · Phase 1

Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients

A Phase 1 study of Discoid Lupus Erythematosus, sponsored by NYU Langone Health.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT00708916: Completed Phase 1 study of Discoid Lupus Erythematosus, sponsored by NYU Langone Health.

NCT00708916 is a Phase 1 study of Discoid Lupus Erythematosus that has completed, run by NYU Langone Health. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% 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

NCT00708916, a Phase 1 study of Discoid Lupus Erythematosus, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.

Primary Outcome

To evaluate the clinical response of cutaneous lupus patients to CC-10004. From J Invest Dermatol. 2005 Nov; 125(5): 889-894.doi: 10.1111/j.0022-202X.2005.23889.x: The CLASI consists of two scores. One summarizes the activity of the disease on a scale from 0 to 30, higher score translates to more severe disease. The second is a measure of the damage done by the disease on a scale form 0 to 30, higher score translates to more severe disease. Activity is scored on the basis of erythema, scale/hyp

Interventions

  • DRUG CC-10004

Study Locations (1)

New York

  • New York University Tisch Hospital - New York

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2008-06
Est. Completion 2010-08
Phase Phase 1
NYU Langone Health

1,164 total trials

What the finished NCT00708916 record still lists

NCT00708916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 1 condition, with Discoid Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which CC-10004 is the first listed.

NCT00708916 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT00708916 about?

NCT00708916 is a clinical study titled "Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients". The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.

What is the current status of trial NCT00708916?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2008-06. Estimated completion is 2010-08.

What conditions does trial NCT00708916 study?

This clinical trial studies the following conditions: Discoid Lupus Erythematosus.

What interventions are being tested in trial NCT00708916?

The interventions under investigation include: CC-10004 (DRUG).

Who is sponsoring clinical trial NCT00708916?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00708916 being conducted?

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

How this trial's enrollment target compares

Where NCT00708916's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00708916, the US trial registry maintained by the National Library of Medicine. NCT00708916 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.