E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic lupus erythematosus (SLE) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042945 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To determine the effective dose/s of edratide for injection.
To evaluate the tolerability and safety of multiple subcutaneous doses of edratide for injection in SLE patients.
To evaluate immunological responses following administration of edratide for injection in SLE patients.
To evaluate the ability of edratide to function as a steroid sparing agent. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal exclusion criteria |
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 </= 50,000/mm3 or creatinine clearance </= 50 ml/min/1.73 m2 as determined by serum creatinine (at screening visit).
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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. AMS (Adjusted mean SLEDAI 2K) calculated from the AUC of SLEDAI change from baseline adjusted over time
2. Landmark analysis (change from baseline ) of SLEDAI 2K measurement scores |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |