Phase 2
Completed N=218
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Lupus Erythematosus, Systemic
Source: ClinicalTrials.gov NCT01753193 ↗
Enrolled (actual)
218
Serious AEs
22.9%
Results posted
Jul 2019
Primary outcomePrimary: Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) — 170; 50 Participants
Summary
The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
170; 50 | — |
| PRIMARY Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab |
17 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESIs) |
11; 1; 2; 4; 1; 1 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab |
5 | — |
| SECONDARY Anti-Drug Antibodies (ADA) Titer to Anifrolumab |
120 | — |
| SECONDARY Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab |
1 | — |
| SECONDARY Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab |
1 | — |
| SECONDARY Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants |
7.8; 5; 1.5; 2.0; 1.8; 2.0 | — |
| SECONDARY Number of ADA-positive Participants With TEAEs and TESAEs |
5; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Must be willing to use 2 methods of effective contraception
- Must have venous access
- Must be willing to forego participation in other clinical trials for SLE.
Exclusion Criteria
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- Major surgery within 8 weeks before signing informed consent form (ICF)
- Elective major surgery planned during the study period
- Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day, Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate > 25 mg/week
- A live or attenuated vaccine within 4 weeks of signing the ICF
- Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
Data sourced from ClinicalTrials.gov (NCT01753193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.