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NCT00624338 · ClinicalTrials.gov registry record · Phase 2
Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 461
- Enrollment target
NCT00624338 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 461 participants.
The verdict
NCT00624338, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 461 participants
- Enrollment target
Study Summary
This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.
Interventions
- OTHER Placebo Comparator
- DRUG Atacicept 75 mg
- DRUG Atacicept 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 461 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00624338
The ClinicalTrials.gov registry entry for NCT00624338 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 461 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 3 interventions - of which Placebo Comparator is the first listed.
NCT00624338 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00624338 about?
NCT00624338 is a clinical study titled "Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)". This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers s...
What is the current status of trial NCT00624338?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 461 participants. The study started on 2008-01. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00624338?
The interventions under investigation include: Placebo Comparator (OTHER), Atacicept 75 mg (DRUG), Atacicept 150 mg (DRUG).
Who is sponsoring clinical trial NCT00624338?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
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