PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus (PEARL-SC)

• ClinicalTrials.gov Identifier: NCT01162681
• Recruitment Status: Completed
• First Posted: July 15, 2010
• Last Update Posted: March 4, 2014
• Sponsor: Anthera Pharmaceuticals
• Information provided by (Responsible Party): Anthera Pharmaceuticals

Tracking Information

• First Submitted Date: July 13, 2010
• First Posted Date: July 15, 2010
• Last Update Posted Date: March 4, 2014
• Study Start Date: July 2010
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2010)

SLE response [ Time Frame: Various timepoints through Week 52 ]

The % of subjects with SLE response compared with baseline at the time of assessment

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 28, 2010)

• B cell reduction [ Time Frame: Various timepoints through Week 52 ]
• Time to first flare [ Time Frame: Various timepoints through Week 52 ]
• FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ]
• Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ]
• Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ]
• Flare rates [ Time Frame: Various timepoints through Week 52 ]
• SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 [ Time Frame: Various timepoints through Week 52 ]

Original Secondary Outcome Measures (submitted: July 13, 2010)

• B cell reduction [ Time Frame: Various timepoints through Week 52 ]
  The percent reduction from baseline in total B cells at the time of assessment
• Time to first flare [ Time Frame: Various timepoints through Week 52 ]
  Time to first flare after randomization
• FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ]
  Change in FACIT score from baseline
• Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ]
  The percent of subjects with a reduction in average prednisone dose
• Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ]
  Change in IgG, IgM, C3, C4 and anti-ds DNA values from baseline and post-baseline time periods

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
• Official Title: A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
• Brief Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Systemic Lupus Erythematosus

Intervention

• Drug: A-623
  High dose given subcutaneously once a week for up to 52 weeks
• Drug: A-623
  Low dose given subcutaneously once a week for up to 52 weeks
• Drug: A-623
  High dose given subcutaneously once every 4 weeks for up to 52 weeks
• Other: Placebo Comparator
  Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks

Study Arms

• Experimental: A-623 high dose weekly
  Intervention: Drug: A-623
• Experimental: A-623 low dose weekly
  Intervention: Drug: A-623
• Experimental: A-623 high dose every 4 weeks
  Intervention: Drug: A-623
• Placebo Comparator: Placebo
  Intervention: Other: Placebo Comparator

Publications *

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
• Furie RA, Leon G, Thomas M, Petri MA, Chu AD, Hislop C, Martin RS, Scheinberg MA; PEARL-SC Study. A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study. Ann Rheum Dis. 2015 Sep;74(9):1667-75. doi: 10.1136/annrheumdis-2013-205144. Epub 2014 Apr 19.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 13, 2012): 547
• Original Estimated Enrollment (submitted: July 13, 2010): 600
• Actual Study Completion Date: April 2012
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of SLE by American College of Rheumatology guidelines.
• On stable SLE treatment
• Active SLE disease
• Serologically active
• 18 years of age or older
• Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

Exclusion Criteria:

• Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
• Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
• Liver disease.
• Anemia, neutropenia, or thrombocytopenia.
• Malignancy within past 5 years
• Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
• History of active tuberculosis or a history of tuberculosis infection.
• Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
• Prior administration of any B cell depleting therapy in the past 18 months.
• Pregnant or nursing
• History of congenital immunodeficiency

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Brazil, Chile, Colombia, Hong Kong, India, Mexico, Peru, Philippines, Taiwan, United States

Administrative Information

• NCT Number: NCT01162681
• Other Study ID Numbers: AN-SLE3321
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Anthera Pharmaceuticals
• Original Responsible Party: Anthera Pharmaceuticals, Inc, Georgina Kilfoil
• Current Study Sponsor: Anthera Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Anthera Pharmaceuticals
• Verification Date: January 2014