Overview

This trial is active, not recruiting.

Condition lupus nephritis
Treatments bms-188667, mycophenolate mofetil, prednisone, placebo matching with bms-188667
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date January 2013
End date February 2017
Trial size 400 participants
Trial identifier NCT01714817, 2012-000714-11, IM101-291

Summary

The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
bms-188667 Abatacept
mycophenolate mofetil Cellcept
prednisone
(Placebo Comparator)
Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
mycophenolate mofetil Cellcept
prednisone
placebo matching with bms-188667

Primary Outcomes

Measure
Proportion of subjects achieving Complete Response of renal disease following 52 weeks of treatment, where complete response is a composite endpoint based on renal function, proteinuria, urine sediment, and corticosteroid dose
time frame: At Day 365

Secondary Outcomes

Measure
Proportion of nephrotic subjects in complete renal response of lupus glomerulonephritis
time frame: At Day 365
Mean change in Urine Protein Creatinine ratio (UPCR) from baseline in nephrotic subjects
time frame: At Day 365
Mean change in UPCR from baseline in overall population
time frame: At Day 365
Proportion of nephrotic subjects in complete renal response of lupus glomerulonephritis
time frame: At Day 729
Proportion of subjects with complete renal response of lupus glomerulonephritis in overall population
time frame: At Day 729
Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response
time frame: At Day 365
Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response
time frame: At Day 729
Time to achieving first complete renal response during the double-blind period
time frame: Day 15 to 729
Time to achieving first partial renal response during the double-blind period
time frame: Day 15 to 729
Proportion of subjects meeting each of the components of PR and CR over time during the double-blind period
time frame: Day 15 to 729
Mean change from baseline in disease activity as measured by BILAG 2004 over time during the double-blind period
time frame: Day 15 to 729
Time to and proportion of subjects with sustained change to lower level of response, ie, CR to PR or NR, PR to NR during the double-blind period
time frame: Day 15 to 729
Time to first lupus treatment failure and proportion of subjects in lupus treatment failures overall, and after achievement of CR or PR during the double-blind period
time frame: Day 15 to 729
Time to first overall treatment failure and proportion of subjects in lupus treatment failure overall, and after achievement of CR or PR during the double-blind period
time frame: Day 15 to 729
Safety assessments based on All adverse events (AEs/SAEs)
time frame: Day 15 and 729
Safety assessments based on AEs of interest (infections, malignancies, autoimmune disorders, and infusional reactions)
time frame: Day 15 to 729
Safety assessments based on AEs of interest (injection site reactions)
time frame: Day 897 to 1065
Safety assessments based on Vital signs
time frame: Day 15 to 729
Safety assessments based on Laboratory test abnormalities
time frame: Day 15 to 729
Immunogenicity assessment based on Proportion of subjects with abatacept induced antibody response over time in the double blind period
time frame: Day 15 to 729
Cmin (µg/mL): Trough level serum concentration of abatacept prior to the administration of the intravenous infusion
time frame: Days 1, 15, 29, 57, 85, 113, 169, 281, 337
Cmax (µg/mL): Maximum observed serum concentration following subjects receiving active abatacept IV
time frame: Day 1 to Day 337
AUC (TAU) (µg•h/mL): Area under the serum concentration time curve over a dosing interval
time frame: Days 337 to 365

Eligibility Criteria

Male or female participants at least 18 years old.

For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Note: Subjects > 16 are eligible for enrollment at selected centers Inclusion Criteria: - Potential subjects must have active lupus nephritis - Biopsy within 12 months prior to screening visit indicating active Class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney) - Urine protein creatinine ratio (UPCR) ≥ 1 at Screening - Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L) - There must also be evidence of active disease within 3 months of Screening, based on at least one of the following: - Worsening of lupus nephritis OR - UPCR ≥ 3 at Screening OR - Active urine sediment OR - Biopsy within 3 months prior to screening visit indicating active Class 3 or Class 4 active proliferative lupus glomerulonephritis Inclusion Criteria for the Long-Term Extension Period: - Signed Written Informed Consent - Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment Exclusion Criteria: - Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis - Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study - Significant active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive - Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible

Additional Information

Official title A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.