Lupus SLE
Conditions
Interventions
- The investigator will do a physical examination - at 2 visits
- The investigator will make an ECG - at 1 visit
- The investigator will take a chest X-ray - at 1 visit
- The investigator will take urine samples and draw blood - at all 17 visits.
Between 1 to 5 tubes of blood are taken each time. This is to monitor your
response to the study drug and also to measur
Sponsors
PPD
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: [1] Are at least 18 years of age., [2] Have a clinical diagnosis of SLE at least 24 weeks prior to screening., [3] Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 ACR criteria for classification of SLE (Tan et al. 1982; Hochberg et al. 1997) prior to randomization., [4] Have 1 or more of the following as assessed by the central lab during screening: a positive antinuclear antibody (ANA; titer >=1:80), and/or a positive anti-dsDNA, and/or a positive anti-Smith (anti-Sm). Patients with an ANA =1:80 may be eligible, as assessed by the eligibility review committee., Note: The ANA, anti-dsDNA, and anti-Smith measurements may be repeated by the central lab once during the screening period, and the value resulting from repeat testing may be accepted for enrollment eligibility if it meets the eligibility criterion., [5] Have a total SLEDAI-2K score >=6 during screening, with at least 4 points attributed to clinical items (not including items requiring laboratory value assessment). SLEDAI-2K items requiring laboratory values should be assessed based on the results from the labs drawn during the screening period., [6] Have a clinical SLEDAI-2K score >=4 at Baseline (Visit 2); not including any items requiring laboratory value assessment., [7] Have at least 1 BILAG A score or 2 BILAG B scores during the screening period. BILAG items requiring laboratory values should be assessed based on the results from the labs drawn during the screening period., Prior/Concomitant Therapy [8] Are receiving at least one of the following SoC medications for SLE:, a. A single antimalarial (such as hydroxychloroquine, chloroquine, quinacrine) at a stable therapeutic dose for at least 8 weeks prior to screening (Visit 1)., b. A single immunosuppressant (such as methotrexate [MTX], azathioprine, mycophenolate, tacrolimus) at a stable therapeutic dose for at least 8 weeks prior to screening (Visit 1)., c. An oral corticosteroid, initiated at least 4 weeks prior to screening (Visit 1), at a stable dose = 7.5 mg/day prednisone (or equivalent)., Patient Characteristics [9] Male or nonpregnant, nonbreastfeeding female patient, a. Patients of child-bearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with the opposite sex., b. Total abstinence is defined as refraining from intercourse during the entirety of the study and for at least 1 week following the last dose of investigational product. Periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception., c. Otherwise, patients of childbearing potential must agree to use 2 effective methods of contraception, where at least 1 form is highly effect
Exclusion criteria
Exclusion criteria: Medical Conditions [1] Have severe active lupus nephritis defined clinically and/or by histologic evidence of proliferative glomerulonephritis on renal biopsy (if available) within the 24 weeks prior to screening, or urine protein/creatinine ratio >200 mg/mmol (as an estimate of approximate proteinuria >2 g/day) or eGFR (Modification of Diet in Renal Disease [MDRD]) = 2) VTE (DVT/PE)., [9] Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data., [10] Have a history of lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly (other than primarily due to SLE); have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years prior to randomization. The following may be exempted: a. Patients with cervical carcinoma in situ that has been resected with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study. b. Patients with basal cell or squamous epithelial skin cancers that have been completely resected with no evidence of recurrence for at least 3 years may pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving an SRI-4 response at Week 52, defined as: * Reduction of >=4 points from baseline in SLEDAI-2K score; and * No new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity score; and * No worsening (defined as an increase of >=0.3 points [10 mm] from baseline) in the Physician*s Global Assessment of Disease Activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Proportion of patients achieving an SRI-4 response at Week 24. * Proportion of patients achieving a lupus low disease activity state (LLDAS) response at Week 52 * Proportion of patients receiving >7.5 mg prednisone (or equivalent) at baseline able to decrease dose by >=25% to a prednisone equivalent dose of 7.5 mg prednisone (or equivalent) at baseline able to decrease dose by >=25% to a prednisone equivalent dose of | — |
Countries
Netherlands
Outcome results
None listed