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NCT01369628 · ClinicalTrials.gov registry record · Phase 1

Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil

A Phase 1 study, sponsored by EMD Serono.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT01369628: Clinical Trial Phase 1 study, sponsored by EMD Serono.

NCT01369628 is a Phase 1 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01369628, a Phase 1 study, was terminated before completion, sponsored by EMD Serono.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

The sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines within a reasonable time frame.

Primary Outcome

Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.

Interventions

  • DRUG Atacicept

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2011-06
Phase Phase 1
EMD Serono

71 total trials

Why NCT01369628 stopped before completion

NCT01369628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Atacicept is the first listed.

NCT01369628 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01369628 about?

NCT01369628 is a clinical study titled "Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil". The sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines within a reasonable time frame.

What is the current status of trial NCT01369628?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2011-06.

What interventions are being tested in trial NCT01369628?

The interventions under investigation include: Atacicept (DRUG).

Who is sponsoring clinical trial NCT01369628?

This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01369628's enrollment target sits among peer trials

1 2001st of 2000 the lowest 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 NCT01369628, the US trial registry maintained by the National Library of Medicine. NCT01369628 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.