An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Overview
- Phase
- Phase 3
- Intervention
- IPP-201101
- Conditions
- Lupus Erythematosus, Systemic
- Sponsor
- ImmuPharma
- Enrollment
- 62
- Locations
- 14
- Primary Endpoint
- Clinical laboratory test results at each visit during the treatment extension period
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus (SLE) who had participated in the main study IP-005.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient had participated previously to study IP-005
- •Written informed consent is obtained.
- •Female and males receiving IPP-201101 and their female partners must use a highly effective contraceptive during treatment and for 30 days after discontinuation of study drug treatment.
- •Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, use a highly effective method of contraception, Men and their partner must have highly effective accepted method of contraception. Single barrier/Double barrier and spermicides are not acceptable methods of contraception. Highly effective methods of contraception include, true abstinence, intrauterine device (IUD), or hormonal contraception associated with inhibition of ovulation (oral, transdermal, implanted, and injected), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject." \[Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception\]
- •If the patient is using oral corticosteroids, the weekly cumulative dose must not exceed 80 mg of prednisone equivalent; the weekly dose must be stable over the 4 weeks preceding the 1st dose of study drug.
- •If the patient is using antimalarials, methotrexate, leflunomide, mycophenolate mofetil (MMF), or azathioprine, the start date must be at least 3 months prior to the 1st dose of study drug, and the daily dose must be stable over the 4 weeks preceding the 1st dose of study drug.
- •If the patient is not currently using corticosteroids, antimalarials, methotrexate, MMF, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to the 1st dose of study drug. For leflunomide, the stop date must be at least 8 weeks before the 1st dose of study drug unless an adequate cholestryamine washout has been performed. If cholestyramine washout is performed, the last use of leflunomide must be at least 4 weeks before the 1st dose of study drug.
- •The patient must be willing and able to comply with study restrictions, to remain at the study center for the required duration during each study visit, and to return to the study center for the final assessment as specified in this protocol.
- •Criteria for Exclusion: Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- •The patient has been treated with intramuscular or intravenous (iv) pulse steroids (ie, 250 to 1000 mg iv total daily dose of methylprednisolone) within 4 weeks of the 1st dose of study drug. The use of intra-articular steroids may be allowed after consultation with the medical expert.
Exclusion Criteria
- Not provided
Arms & Interventions
IPP-201101
every 4 weeks
Intervention: IPP-201101
Outcomes
Primary Outcomes
Clinical laboratory test results at each visit during the treatment extension period
Time Frame: 7 months
Summary statistics for laboratory tests will be presented at baseline and at each visit.The severity of select laboratory resuts will be graded accroding the Modified WHO Toxicity Criteria.
Pulse measurements at each visit during the treatment period
Time Frame: 7 months
The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
Concomitant medication usage throughout the study extension
Time Frame: 7 months
All concomittant medication will be coded using the WHO Drug dictionnary. The incidence of concomittant medications will be sumamrized using descriptive statistics by therapeutic class and preferred terms category.
Occurrence of adverse events throughout the study
Time Frame: 7 months
all adverse events will be coded using MedDRA and the sverity will be graded according to the modified WHO toxicity Criteria and they will be determined by the Investigator to be treatment related. The incidence of adverse events will be summarized using descriptive statistics by system organ classe and preferred term.
Body weight measurements at each visit during the treatment period
Time Frame: 7 months
The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
Temperature measurements at each visit during the treatment period
Time Frame: 7 months
The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
Systolic and diastolic blood pressures measurements at each visit during the treatment period
Time Frame: 7 months
The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
Physical examination findings, at specified time points at each visit during the treatment extension period
Time Frame: 7 months
Body system (General appearance, Skin, HEENT (Head, eyes, ears, nose, throat), Lymph Nodes, Thyroïd, Musculo-skeletal / Extremities, Cardiovascular, Lungs, Abdomen, Neurological) findings that is judged by the investigator as a clinically significant change (worsening) compared to a baseline value will be considered an adverse event coded using MedDRA
2-lead electrocardiogram (ECG) findings at week 28 (or final assessment)
Time Frame: 7 months
Any ECG finding that is judged by the investigator as a clinically significant change (worsening) compared to a baseline value will be considered an adverse event coded using MedDRA
Secondary Outcomes
- the effect in the Clinical SLEDAI-2K total score by at final visit compared to initial visit(at week 28)
- remission of the disease (i.e reduction of clinical SLEDAI-2K score to 0)(at week 28)