AN ADAPTIVE PHASE II STUDY TO EVALUATE THE EFFICACY, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF GSK2586184 IN PATIENTS WITH MILD TO MODERATE SYSTEMIC LUPUS ERYTHEMATOSUS

Not Applicable

• Conditions: -M32 Systemic lupus erythematosus; Systemic lupus erythematosus; M32

• Registration Number: PER-126-12
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. AGE AND GENDER: MALE OR FEMALE BETWEEN 18 AND 75 YEARS OF AGE INCLUSIVE, AT THE TIME OF SIGNING THE INFORMED CONSENT.
2. SLE CLASSIFICATION: HAVE A CLINICAL DIAGNOSIS OF SLE ACCORDING TO THE AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CLASSIFICATION CRITERIA, WITH 4 OR MORE OF THE 11 ACR CRITERIA PRESENT, SERIALLY OR SIMULTANEOUSLY DURING ANY INTERVAL OR OBSERVATION (SEE APPENDIX 2).
3. SEVERITY OF DISEASE: HAVE CLINICALLY ACTIVE SLE DISEASE DEFINED AS A SELENA SLEDAI SCORE ≥ 8 AT SCREENING.
4. AUTO ANTIBODIES: ARE SEROLOGICALLY ACTIVE HAVING UNEQUIVOCALLY POSITIVE ANTI¬NUCLEAR ANTIBODY (ANA) OR ANTI-DOUBLE STRANDED DNA (ANTI-DSDNA) ANTIBODY TEST RESULTS FROM 2 INDEPENDENT TIME POINTS AS FOLLOWS:
. POSITIVE TEST RESULTS FROM 2 INDEPENDENT TIME POINTS WITHIN THE STUDY SCREENING PERIOD. SCREENING RESULTS MUST BE BASED ON THE STUDY´S CENTRAL LABORATORY RESULTS. A POSITIVE TEST IS DEFINED AS A POSITIVE ANA TEST EQUIVALENT TO A TITRE ≥ 1:80 AS DEFINED IN THE CENTRAL LABORATORY MANUAL AND/OR A POSITIVE ANTI-DSDNA (≥ 30 IU/ML) SERUM ANTIBODY.
OR
. ONE POSITIVE HISTORICAL TEST RESULT AND 1 POSITIVE TEST RESULT FOR EITHER ANA OR ANTI-DSDNA DURING THE SCREENING PERIOD.

Exclusion Criteria

1. KIDNEY DISEASE: HAVE KIDNEY DISEASE MEETING THE FOLLOWING DEFINITION:
PROTEINURIA > 0.5G/24 HOUR OR EQUIVALENT SPOT URINE PROTEIN TO CREATININE RATIO OF 0.5MG/MG OR;
SERUM CREATININE > 1.5 X UPPER LIMIT OF NORMAL (ULN) OR;
HAVE ACTIVE NEPHRITIS REQUIRING ACUTE THERAPY NOT PERMITTED BY PROTOCOL (E.G., INTRAVENOUS (IV) CYCLOPHOSPHAMIDE) OR;
HAVE REQUIRED PERITONEAL DIALYSIS OR HEMODIALYSIS OR HIGH DOSE CORTICOSTEROID (> 100 MG/DAY PREDNISONE OR EQUIVALENT) WITHIN 90 DAYS PRIOR TO FIRST DOSE OR;
HAVE HAD ACTIVE RENAL DISEASE SHOWN ON RENAL BIOPSY IN THE THREE MONTHS PRIOR TO SCREENING.
2. CNS DISEASE: HAVE ACTIVE CENTRAL NERVOUS SYSTEM (CNS) LUPUS (INCLUDING SEIZURES, PSYCHOSIS, ORGANIC BRAIN SYNDROME, CEREBROVASCULAR ACCIDENT [CVA], CEREBRITIS OR CNS VASCULITIS) REQUIRING THERAPEUTIC INTERVENTION WITHIN 60 DAYS PRIOR TO FIRST DOSE.
3. ALCOHOL ABUSE: EVIDENCE OR, IN THE OPINION OF THE INVESTIGATOR, SUSPICION OF ALCOHOL CONSUMPTION EXCEEDING NATIONAL GUIDELINES AND / OR SYMPTOMS OF ALCOHOL DEPENDENCY.
4. SUBSTANCE ABUSE: HAVE EVIDENCE OF CURRENT RECREATIONAL DRUG ABUSE OR DEPENDENCE.

Study & Design

• Study Type: Interventional
• Study Design: Not specified