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

Lupus Erythematosus, Systemic Clinical Trial

Official title:

A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753193
• Other study ID #: CD-IA-MEDI-546-1145
• Secondary ID: 2012-004619-30
• Status: Completed
• Phase: Phase 2
• Start date: March 28, 2013
• Est. completion date: July 18, 2018

Study information

• Verified date: July 2019
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Biological:
• Anifrolumab
Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.

Locations

Country	Name	City	State
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Paulo
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Colombia	Research Site	Bucaramanga
Colombia	Research Site	Chia
Colombia	Research Site	Medellin
Czechia	Research Site	Brno
Czechia	Research Site	Praha 2
Hungary	Research Site	Debrecen
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Seodaemun-gu
Korea, Republic of	Research Site	Suwon-si
Mexico	Research Site	Guadalajara
Mexico	Research Site	Leon
Mexico	Research Site	Mexico
Mexico	Research Site	Toluca
Peru	Research Site	Arequipa
Peru	Research Site	Lima
Peru	Research Site	Lima
Poland	Research Site	Bialystok
Poland	Research Site	Krakow
Poland	Research Site	Nadarzyn
Poland	Research Site	Poznan
Romania	Research Site	Iasi
Taiwan	Research Site	Chiayi
Taiwan	Research Site	Zhongzheng District
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Ternopil
Ukraine	Research Site	Vinnitsya
Ukraine	Research Site	Vinnytsia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Birmingham	Alabama
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	La Palma	California
United States	Research Site	Las Cruces	New Mexico
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Memphis	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Ocala	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Palm Desert	California
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Spokane	Washington
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Tampa	Florida
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.	From first dose of study drug (Day 1) through 168 weeks
Primary	Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab	Number of participants with DAEs are reported.	From first dose of study drug (Day 1) through 168 weeks
Primary	Number of Participants With Adverse Events of Special Interest (AESIs)	An AESI is scientific and medical concern specific to understanding of the study drug. An AESI may be serious or non-serious. Number of participants with AESIs are reported.	From first dose of study drug (Day 1) through 168 weeks
Secondary	Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab	The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.	Baseline (Pre-dose on Day 1) up to Week 168
Secondary	Anti-Drug Antibodies (ADA) Titer to Anifrolumab	Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.	Baseline (Pre-dose on Day 1) up to Week 168
Secondary	Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab	Number of participants with decreased serum concentration of anifrolumab due to ADA-positive results are reported.	Baseline (Pre-dose on Day 1) up to Week 168
Secondary	Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab	Number of participants with decreased pharmacodynamic response of anifrolumab due to ADA-positive results are reported.	Baseline (Pre-dose on Day 1) up to Week 168
Secondary	Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants	The SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).	Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168
Secondary	Number of ADA-positive Participants With TEAEs and TESAEs	The number of ADA-positive participants with TEAEs and TESAEs are reported.	Baseline (Pre-dose on Day 1) up to Week 168