An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01753193
• Date of registration: 17/12/2012
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
• Scientific title: A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
• Date of first enrolment: March 28, 2013
• Target sample size: 218
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01753193
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Brazil, Bulgaria, Colombia, Czech Republic, Czechia, Hungary, Korea, Republic of, Mexico, Peru, Poland, Romania, Taiwan, Ukraine, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 68 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Biological: Anifrolumab

Primary Outcome(s)

Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [Time Frame: From first dose of study drug (Day 1) through 168 weeks]

Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab [Time Frame: From first dose of study drug (Day 1) through 168 weeks]

Number of Participants With Adverse Events of Special Interest (AESIs) [Time Frame: From first dose of study drug (Day 1) through 168 weeks]

Secondary Outcome(s)

Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants [Time Frame: Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168]

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab [Time Frame: Baseline (Pre-dose on Day 1) up to Week 168]

Anti-Drug Antibodies (ADA) Titer to Anifrolumab [Time Frame: Baseline (Pre-dose on Day 1) up to Week 168]

Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab [Time Frame: Baseline (Pre-dose on Day 1) up to Week 168]

Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab [Time Frame: Baseline (Pre-dose on Day 1) up to Week 168]

Number of ADA-positive Participants With TEAEs and TESAEs [Time Frame: Baseline (Pre-dose on Day 1) up to Week 168]

Secondary ID(s)

2012-004619-30

CD-IA-MEDI-546-1145

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01753193