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NCT02070978 · ClinicalTrials.gov registry record · Phase 2

Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

A Phase 2 study, sponsored by EMD Serono.

Terminated
Registry status
Phase 2
Development phase
253
Enrollment target

NCT02070978 is a Phase 2 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 253 participants.

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The verdict

NCT02070978, a Phase 2 study, was terminated before completion, sponsored by EMD Serono.

TERMINATED
Registry status
Phase 2
Development phase
253 participants
Enrollment target

Study Summary

This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.

Interventions

  • DRUG Atacicept 75 mg
  • DRUG Atacicept 150 mg

Trial Details

FieldValue
Enrollment Target 253 participants
Start Date 2014-07-29
Est. Completion 2018-02-09
Phase Phase 2

Sponsor

EMD Serono

71 total trials

What the Registry Record Tells You About NCT02070978

The ClinicalTrials.gov registry entry for NCT02070978 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 253 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Atacicept 75 mg is the first listed.

NCT02070978 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02070978 about?

NCT02070978 is a clinical study titled "Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)". This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ...

What is the current status of trial NCT02070978?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 253 participants. The study started on 2014-07-29. Estimated completion is 2018-02-09.

What interventions are being tested in trial NCT02070978?

The interventions under investigation include: Atacicept 75 mg (DRUG), Atacicept 150 mg (DRUG).

Who is sponsoring clinical trial NCT02070978?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.