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

Inclusion Criteria:

1. Man or woman ≥ 18 years and < 65 years of age

2. 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

3. Have moderate to severe active SLE

4. Have seropositive disease at screening

5. Subject must be at least on one or more of the treatments for SLE as listed in the
protocol

6. Others as defined in the protocol

Exclusion Criteria:

1. 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

2. Have a systemic inflammatory disease other than SLE

3. Clinically significant infection treated or needing treatment

4. Any active or recurrent viral infection that based on the Investigator´s clinical
assessment makes the subject unsuitable for the study

5. Have received prior therapy blocking the interleukin-6 (IL-6) pathway

6. Others as defined in the protocol