A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus (SLE)MedDRA version: 9.1Level: HLTClassification code 10025135Term: Lupus erythematosus (incl subtypes)
- Registration Number
- EUCTR2007-004892-21-BG
- Lead Sponsor
- IMMUPHARMA SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 296
1.Men and women > 18 and < 70 years of age.
2.Women must be of non-childbearing potential, or if of childbearing potential (as determined by the investigator) must be using an effective method of birth control for 30 days prior to first administration of study drug and must agree to continue such precautions for the duration of the study.
3.Capable of understanding and complying with the protocol and be available for the duration of the study
4.Signed written informed consent form prior to initiation of any study related procedures
5.Established diagnosis of Systemic Lupus Erythematosus (SLE) defined by ACR Classification Revised Criteria (1997). The diagnosis is fulfilled provided that at least 4 criteria are met
6.A SLEDAI-2K score of at least 6 points and no A score on the BILAG scale
7.Positive test for antinuclear antibodies (ANA)
8.If using oral corticosteroids:
•The weekly cumulative dose must not exceed 80mg of prednisone equivalent or 72 mg budesonide;
•the weekly dose must be stable over the 4 weeks preceding study start
9.If using antimalarials, methotrexate, leflunomide, mycophenolate mofetil, or azathioprine:
•the start-date must be at least 3 months prior to study start and
•the daily dose must be stable over the 4 weeks preceding the study start
10.If not currently using corticosteroids, antimalarials, methotrexate, mycophenolate mofetyl, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to study start. For leflunomide, the stop date must be at least 8 weeks before study start, unless an adequate cholestyramine wash-out has been completed
11.If using angiotensin converting enzyme inhibitors or angiotensin receptor antagonists must be stable for at least 4 weeks prior to baseline assessment
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) yes
F.1.3.1 Number of subjects for this age range
1.Female subjects of childbearing potential unless using a reliable contraception method and women who are pregnant or lactating
2.Treatment with dosage of prednisone equivalent > 80 mg /week (or > 72 mg of budesonide).
3.Treatment with intravenous pulse steroids within 4 weeks of Baseline.
4.Intravenous immunoglobulins (IgG), cyclophosphamide, or cyclosporine A within 3 months of Baseline.
5.Treatment with biologic agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 12 months of study start.
6.Subjects having received B-cell depleting agents such as rituximab who have not yet normalized their B-cell count
7.Planned immunization with a live vaccine within 3 months prior to study treatment start and 3 months after treatment cessation
8.Previous or current history of malignancy (except subjects with a remote history (e.g greater than 5 years previously) of basal cell carcinoma, cervical carcinoma in situ).
9.Clinically significant abnormalities on chest X-Ray or electrocardiogram that are not related to SLE, as defined by the Principal Investigator
10.Any concomitant medical condition unrelated to SLE, which in the opinion of the Principal Investigator, may interfere with the safety or the evaluation of the study, including:
•Chronic heart failure, previous myocardial infarction, chest pain within the last 3 months with changes in ECG and/or increased cardiac enzymes,
•Ongoing active infection requiring antibiotic therapy,
•Severe infection, such as hepatitis or pneumonia in the past three months. Ongoing active infection requiring antibiotic therapy, Less severe infections in the past 3 months are permitted at the discretion of the Principal Investigator
•Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive
•Chronic liver failure,
•Uncontrolled diabetes mellitus,
11.Current drug and alcohol abuse as evidenced by medical history at Screening
12.Psychiatric, addictive, or any other disorder that compromises the ability to give truly informed written consent for participation in this study
13.Subjects with a history of severe allergic reactions to or hypersensitivity to any component of the drug or placebo
14.Has undergone or is undergoing treatment with another investigational drug within 6 months prior to entry in this study
15.Cyclophosphamide is not allowed within 12 months prior to study start and throughout the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method