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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: Completed Phase 2 study, sponsored by Ablynx, a Sanofi company.
NCT02437890 is a Phase 2 study that has completed, run by Ablynx, a Sanofi company. The registered enrollment target is 312 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint was evaluated by determining if there was a dose-response relationship between the mBICLA response rate at Week 24 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. The existence of several candidate parametric models was assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve. The selected model could further be used to guide the choice of
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 |
What the finished NCT02437890 record still lists
NCT02437890 is an interventional study that assigns participants to a tested intervention. The registered 312 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 (135% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02437890 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02437890's enrollment target sits among peer trials
312 161st of 2000 higher than 1,839 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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