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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01162681
First received: July 13, 2010
Last updated: January 30, 2014
Last verified: January 2014

July 13, 2010
January 30, 2014
July 2010
April 2012   (final data collection date for primary outcome measure)
SLE response [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
The % of subjects with SLE response compared with baseline at the time of assessment
Same as current
Complete list of historical versions of study NCT01162681 on ClinicalTrials.gov Archive Site
  • B cell reduction [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
  • Time to first flare [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
  • FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
  • Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
  • Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
  • Flare rates [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
  • SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
  • B cell reduction [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time to first flare after randomization
  • FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
    Change in FACIT score from baseline
  • Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in IgG, IgM, C3, C4 and anti-ds DNA values from baseline and post-baseline time periods
Not Provided
Not Provided
 
PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
547
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico,   United States,   Hong Kong,   India,   Philippines,   Taiwan,   Argentina,   Brazil,   Chile,   Colombia,   Peru
 
NCT01162681
AN-SLE3321
Yes
Anthera Pharmaceuticals
Anthera Pharmaceuticals
Not Provided
Not Provided
Anthera Pharmaceuticals
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP