A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
Public ClinicalTrials.gov record NCT02437890. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02437890
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 312 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2015
- Primary completion
- Dec 31, 2017
- Completion
- Dec 31, 2017
- Last update posted
- Feb 25, 2019
2015 – 2018
United States locations
- U.S. sites
- 28
- U.S. states
- 13
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator Site | Birmingham | Alabama | 35294 | — |
| Investigator Site | Glendale | Arizona | 85306 | — |
| Investigator Site | Phoenix | Arizona | 85032 | — |
| Investigator Site | Tucson | Arizona | 85724 | — |
| Investigator Site | Artesia | California | 90701 | — |
| Investigator Site | La Jolla | California | 92093 | — |
| Investigator Site | La Palma | California | 90623 | — |
| Investigator Site | Los Angeles | California | 90057 | — |
| Investigator Site | Upland | California | 91786 | — |
| Investigator Site | Aventura | Florida | 33180 | — |
| Investigator Site | Clearwater | Florida | 33765 | — |
| Investigator Site | Orlando | Florida | 32806 | — |
| Investigator Site | Pinellas Park | Florida | 33781 | — |
| Investigator Site | Atlanta | Georgia | 30342 | — |
| Investigator Site | Stockbridge | Georgia | 30281 | — |
| Investigator Site | Louisville | Kentucky | 40217 | — |
| Investigator Site | Cumberland | Maryland | 21502 | — |
| Investigator Site | Lansing | Michigan | 48910 | — |
| Investigator Site | New York | New York | 10016 | — |
| Investigator Site | New York | New York | 10032 | — |
| Investigator Site | Smithtown | New York | 11787 | — |
| Investigator Site | Syracuse | New York | 13210 | — |
| Investigator Site | Charlotte | North Carolina | 28210 | — |
| Investigator Site | Raleigh | North Carolina | 27617 | — |
| Investigator Site | Pittsburgh | Pennsylvania | 15213 | — |
| Investigator Site | Jackson | Tennessee | 38305 | — |
| Investigator Site | Austin | Texas | 78745 | — |
| Investigator Site | Houston | Texas | 77034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 90 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02437890, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 25, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02437890 live on ClinicalTrials.gov.