Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02265744
• Date of registration: 15/10/2014
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
• Scientific title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus
• Date of first enrolment: November 13, 2014
• Target sample size: 730
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02265744
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Netherlands, Peru, Poland, Puerto Rico, Qatar, Romania, Russian Federation, South Africa, Spain, Taiwan, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Male or female aged between 18 to 70 (included)

- Diagnosed with active systemic lupus erythematosus by a doctor

- Disease must be in patient's joints or on the skin at a minimum

- Taking other medications is allowed but some are excluded

Exclusion Criteria:

- Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis

- Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus

Intervention(s)

Drug: Placebo matching BMS-931699

Drug: BMS-931699

Primary Outcome(s)

Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 [Time Frame: At Day 169]

Secondary Outcome(s)

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2 [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85 [Time Frame: At Day 85]

Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified [Time Frame: Day 169]

Change From Baseline in Arthritis, as Assessed by American College of Rheumatology (ACR) 28-joint Count of Tender and Swollen Joints on Day 85 and Day 169 [Time Frame: At baseline, Day 85 and Day 169]

Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score [Time Frame: At Day 85 and Day 169]

Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate [Time Frame: At Day 85 and Day 169]

Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 [Time Frame: At Day 169]

Short Term: Receptor Occupancy Over Time [Time Frame: At Day 85 and Day 169]

Cumulative Corticosteroid and Immunosuppressant Use [Time Frame: Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlier]

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1 [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2 [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [Time Frame: Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier.]

Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169 [Time Frame: At baseline, Day 85 and Day 169]

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3 [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169 [Time Frame: At baseline, Day 85 and Day 169]

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate [Time Frame: At Day 85 and Day 169]

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest [Time Frame: On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlier]

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1 [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3 [Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period]

Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature [Time Frame: At Day 85 and Day 169]

Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169 [Time Frame: At baseline, Day 85 and Day 169]

Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified [Time Frame: Day 169]

Mean Change From Baseline in CLASI Score at Day 85 and Day 169 [Time Frame: At Day 85 and Day 169]

Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85 [Time Frame: At Day 85]

Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure [Time Frame: At Day 85 and Day 169]

Serum Biomarkers C3, C4 [Time Frame: At Day 85 and Day 169]

Serum Biomarkers: Anti-Nuclear Antibodies (ANA) [Time Frame: At Day 85 and Day 169]

Secondary ID(s)

2014-002184-14

IM128-027

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02265744