Clinical trial NCT01753193: An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Official title: A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Keywords: Systemic Lupus Erythematosus
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an Open Label Extension study.
Primary purpose: TREATMENT

Brief 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).

Detailed description: This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE. Participants must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.

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

Primary outcomes:
measure: Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From first dose of study drug (Day 1) through 168 weeks
measure: Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
timeFrame: From first dose of study drug (Day 1) through 168 weeks
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: From first dose of study drug (Day 1) through 168 weeks
Secondary outcomes:
measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab
timeFrame: Baseline (Pre-dose on Day 1) up to Week 168
measure: Anti-Drug Antibodies (ADA) Titer to Anifrolumab
timeFrame: Baseline (Pre-dose on Day 1) up to Week 168
measure: Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab
timeFrame: Baseline (Pre-dose on Day 1) up to Week 168
measure: Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab
timeFrame: Baseline (Pre-dose on Day 1) up to Week 168
measure: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
timeFrame: Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168
measure: Number of ADA-positive Participants With TEAEs and TESAEs
timeFrame: Baseline (Pre-dose on Day 1) up to Week 168
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: La Palma
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Palm Desert
country: United States
facility: Research Site
state: California
city: Upland
country: United States
facility: Research Site
state: California
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Las Cruces
country: United States
facility: Research Site
state: New Mexico
city: New York
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bucaramanga
country: Colombia
facility: Research Site
city: Chia
country: Colombia
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Seodaemun-gu
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Leon
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Toluca
country: Mexico
facility: Research Site
city: Arequipa
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Nadarzyn
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Chiayi
country: Taiwan
facility: Research Site
city: Zhongzheng District
country: Taiwan
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Vinnitsya
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
Study officials:
References:
citation: Chatham WW, Furie R, Saxena A, Brohawn P, Schwetje E, Abreu G, Tummala R. Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. Arthritis Rheumatol. 2021 May;73(5):816-825. doi: 10.1002/art.41598. Epub 2021 Mar 24.