Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02437890 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
A Phase 2 study, sponsored by Ablynx, a Sanofi company.
- Completed
- Registry status
- Phase 2
- Development phase
- 312
- Enrollment target
NCT02437890 is a Phase 2 study that has completed, run by Ablynx, a Sanofi company. The registered enrollment target is 312 participants.
The verdict
NCT02437890, a Phase 2 study, has completed, sponsored by Ablynx, a Sanofi company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 312 participants
- Enrollment target
Study Summary
Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo. Secondary objectives: To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL ALX-0061
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02437890
The ClinicalTrials.gov registry entry for NCT02437890 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ablynx, a Sanofi company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02437890 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02437890 about?
NCT02437890 is a clinical study titled "A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus". Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo. Secondary objectives: To assess the pharmacokinetics (PK)...
What is the current status of trial NCT02437890?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2015-07. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02437890?
The interventions under investigation include: Placebo (BIOLOGICAL), ALX-0061 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02437890?
This trial is sponsored by Ablynx, a Sanofi company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.