A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE
- Conditions
- Systemic lupus erythematosus (SLE)MedDRA version: 7.1Level: PTClassification code 10042945
- Registration Number
- EUCTR2005-001391-12-ES
- Lead Sponsor
- TEVA Pharmaceutical Industries, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
1. Subjects must be willing and able to give written informed consent prior to entering the study.
2. Subjects must be between the ages of 18 and 65 years (inclusive).
3. SLE patients who fulfilled at least 4 classification criteria (1997 revised) of the American College of Rheumatology for SLE by the time of screening visit.
4. SLE patients with moderate, active disease, who score between 6 and 12 (inclusive) on SLE disease activity index 2K (SLEDAI 2K) at screening visit and re-confirmed before randomization.
5. Subjects treated with chronic concomitant medication must be taking a stable dose of SLE medications for at least 4 weeks before randomization.
6. Women of child-bearing potential must practice a medically acceptable method of contraception.
7. Subjects must understand the requirements of the study and agree to comply with the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Women who are pregnant, breast-feeding or intending to become pregnant within 6 months of last dose of study drug.
2. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.
3. Subjects having a history of chronic infection that has been active within 3 months prior to randomization or latent tuberculosis.
4. Subjects with hemoglobin < 8.5 gm/dl or neutrophils < 1,000/mm3, or platelets
5. Subjects with urine protein to creatinine ratio (at screening visit) of either > 0.75 or unstable urine protein to creatinine ratio between 0.5 and 0.75 and/or hematuria (lupus related) and/or pyuria (lupus related) and/or with cellular casts (RBC or WBC).
6. Active, CNS lupus manifestations (including lupus headache) as defined in SLEDAI 2K descriptors during the 3 months prior to randomization.
7. Subjects with a history of immunodeficiency syndrome or malignancy, except subjects with cervical cancer, basal cell or squamous cell carcinoma of the skin more than 5 years prior to screening visit.
8. Subjects who presented a positive laboratory test for Hepatitis B surface antigen (HbsAg), or HCV antibody.
9. Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization, or who are scheduled to receive another investigational drug during the course of the study or within 4 months following the last dose of the study.
10. Subjects receiving daily treatment of 40 mg or more of prednisone / prednisolone a day or subjects treated with other steroids or regimens at screening visit.
11. Subjects treated with any cytotoxic agents (e.g. cyclophosphamide, mycophenolate mofetil, cyclosporin, leflunomide, chlorambucil) or any immunosuppressive agents or immunomodulators not mentioned above (e.g. Remicade, Enbrel), or IV Ig or plasmapheresis in the 3 months prior to randomization and/or azathioprine and methotrexate in the 4 weeks prior to randomization.
12. Diagnosis of drug-induced lupus [at any time in the past].
13. History of allergy to SBECD (sulfobutyl ether beta-cyclodextrin sodium, Captisol®) or other cyclodextrins.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of a once a week administration of three doses of edratide for injection on overall disease activity in SLE patients in comparison to placebo.;Secondary Objective: To determine the effective dose/s of edratide for injection.<br><br>To evaluate the tolerability and safety of multiple subcutaneous doses of edratide for injection in SLE patients.<br><br>To evaluate immunological responses following administration of edratide for injection in SLE patients.<br><br>To evaluate the ability of edratide to function as a steroid sparing agent.;Primary end point(s): 1. AMS (Adjusted mean SLEDAI 2K) calculated from the AUC of SLEDAI change from baseline adjusted over time <br><br>2. Landmark analysis (change from baseline ) of SLEDAI 2K measurement scores
- Secondary Outcome Measures
Name Time Method