Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (IP-006)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03427151|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2018
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic||Drug: IPP-201101||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 27, 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||March 2019|
every 4 weeks
200 mcg of IPP-201101 will be administered subcutaneously every 4 weeks for 24 weeks.
- 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.
- 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.
- 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.
- 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.
- Systolic and diastolic blood pressures measurements at each visit during the treatment period [ Time Frame: 7 months ]
- 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
- 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
- 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.
- the effect in the Clinical SLEDAI-2K total score by at final visit compared to initial visit [ Time Frame: at week 28 ]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.
- remission of the disease (i.e reduction of clinical SLEDAI-2K score to 0) [ Time Frame: at week 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427151
|United States, California|
|Los Angeles, California, United States, 90211|
|East Bay Rheumatology Medical|
|San Leandro, California, United States, 94578|
|United States, Florida|
|Arthritis and Rheumatic Disease Specialties|
|Aventura, Florida, United States, 33180|
|United States, Nevada|
|Innovative Health Research|
|Las Vegas, Nevada, United States, 89128|
|Revmatologický ústav v Praze|
|GHR Mulhouse Sud-Alsace|
|CHU de la Réunion|
|Clinic for Rheumatology and Internal Medicine|
|University of Debrecen Medical Center Department of Clinical Immunology|
|Mentaház Magánorvosi Központ Kft.|
|Latin Clinical Trial Center|
|San Juan, Puerto Rico, 00909|