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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
200 mcg of IPP-201101 will be administered subcutaneously every 4 weeks for 24 weeks.
WALLACE
Los Angeles, California, United States
East Bay Rheumatology Medical
San Leandro, California, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Occurrence of adverse events throughout the study
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.
Time frame: 7 months
Clinical laboratory test results at each visit during the treatment extension period
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.
Time frame: 7 months
Body weight measurements at each visit during the treatment period
The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
Time frame: 7 months
Temperature measurements at each visit during the treatment period
The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
Time frame: 7 months
Pulse measurements at each visit during the treatment period
The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
Time frame: 7 months
Systolic and diastolic blood pressures measurements at each visit during the treatment period
The incidence of clinically significant abonormal values will be summarized using descriptive statistics.
Time frame: 7 months
2-lead electrocardiogram (ECG) findings at week 28 (or final assessment)
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Innovative Health Research
Las Vegas, Nevada, United States
Revmatologie s.r.o.
Brno, Czechia
Revmatologický ústav v Praze
Prague, Czechia
GHR Mulhouse Sud-Alsace
Mulhouse, France
CHU de la Réunion
Saint-Denis, France
Schlosspark-Klinik Berlin
Berlin, Germany
Clinic for Rheumatology and Internal Medicine
Freiburg im Breisgau, Germany
...and 4 more locations
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
Time frame: 7 months
Physical examination findings, at specified time points at each visit during the treatment extension period
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
Time frame: 7 months
Concomitant medication usage throughout the study extension
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.
Time frame: 7 months
the effect in the Clinical SLEDAI-2K total score by at final visit compared to initial visit
The SLEDAI 2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The SLEDAI-2K clinical score is the calculated score without inclusion of the points that may be contributed by having a psoitive titer fr anti-dsdna Ab or decreased serum complement level. The SLEDAI-2K clinical score (sum of 22 scores) ranges from 0 to 101.
Time frame: at week 28
remission of the disease (i.e reduction of clinical SLEDAI-2K score to 0)
Time frame: at week 28