A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID

NCT02437890

Run by

Ablynx, a Sanofi company

People needed

312

Starts

2015-07-01

Expected to finish

2018-01-01

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Man or woman ≥ 18 years and < 65 years of age
• Have a diagnosis of SLE for at least 6 months prior to screening and fulfill the 1997 American College of Rheumatology (ACR) or 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
• Have moderate to severe active SLE
• Have seropositive disease at screening
• Subject must be at least on one or more of the treatments for SLE as listed in the protocol
• Others as defined in the protocol

You may not qualify if…

• Have an A score on the revised BILAG-2004 other than in the mucocutaneous and/or musculoskeletal system at screening and at baseline for the organ systems that can be clinically assessed
• Have a systemic inflammatory disease other than SLE
• Clinically significant infection treated or needing treatment
• Any active or recurrent viral infection that based on the Investigator´s clinical assessment makes the subject unsuitable for the study
• Have received prior therapy blocking the interleukin-6 (IL-6) pathway
• Others as defined in the protocol

Where it is running

• Investigator Site — Glendale, Arizona, United States
• Investigator Site — Phoenix, Arizona, United States
• Investigator Site — Tucson, Arizona, United States
• Investigator Site — Artesia, California, United States
• Investigator Site — La Jolla, California, United States
• Investigator Site — La Palma, California, United States
• Investigator Site — Los Angeles, California, United States
• Investigator Site — Upland, California, United States
• Investigator Site — Aventura, Florida, United States
• Investigator Site — Clearwater, Florida, United States
• Investigator Site — Orlando, Florida, United States
• Investigator Site — Pinellas Park, Florida, United States
• Investigator Site — Atlanta, Georgia, United States
• Investigator Site — Stockbridge, Georgia, United States
• Investigator Site — Louisville, Kentucky, United States
• Investigator Site — Cumberland, Maryland, United States
• Investigator Site — Lansing, Michigan, United States
• Investigator Site — New York, New York, United States
• Investigator Site — New York, New York, United States
• Investigator Site — Smithtown, New York, United States
• Investigator Site — Syracuse, New York, United States
• Investigator Site — Charlotte, North Carolina, United States
• Investigator Site — Raleigh, North Carolina, United States
• Investigator Site — Pittsburgh, Pennsylvania, United States
• Investigator Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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