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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: Clinical Trial Phase 2 study, sponsored by EMD Serono.
NCT02070978 is a Phase 2 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 253 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpati
Interventions
- DRUG Atacicept 75 mg
- DRUG Atacicept 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2014-07-29 |
| Est. Completion | 2018-02-09 |
| Phase | Phase 2 |
Why NCT02070978 stopped before completion
NCT02070978 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 2 interventions - of which Atacicept 75 mg is the first listed.
NCT02070978 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02070978's enrollment target sits among peer trials
253 220th of 2000 higher than 1,781 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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