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NCT00657007 · ClinicalTrials.gov registry record · Phase 1

Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 1 study, sponsored by Human Genome Sciences.

Completed
Registry status
Phase 1
Development phase
70
Enrollment target

NCT00657007: Completed Phase 1 study, sponsored by Human Genome Sciences.

NCT00657007 is a Phase 1 study that has completed, run by Human Genome Sciences. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00657007, a Phase 1 study, has completed, sponsored by Human Genome Sciences.

COMPLETED
Registry status
Phase 1
Development phase
70 participants
Enrollment target

Study Summary

The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL belimumab

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2002-02
Est. Completion 2003-03
Phase Phase 1
Human Genome Sciences

17 total trials

What the finished NCT00657007 record still lists

NCT00657007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00657007 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00657007 about?

NCT00657007 is a clinical study titled "Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)". The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.

What is the current status of trial NCT00657007?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2002-02. Estimated completion is 2003-03.

What interventions are being tested in trial NCT00657007?

The interventions under investigation include: Placebo (BIOLOGICAL), belimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00657007?

This trial is sponsored by Human Genome Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00657007's enrollment target sits among peer trials

70 749th of 2000 higher than 1,227 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 NCT00657007, the US trial registry maintained by the National Library of Medicine. NCT00657007 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.