A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (LUPUZOR)
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|ClinicalTrials.gov Identifier: NCT02504645|
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic||Drug: IPP-201101 Drug: Placebo Other: Standard of Care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 2018|
Active Comparator: IPP-201101 200-mcg plus SOC
Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Other Name: Lupuzor, regiremod
Other: Standard of Care
Placebo Comparator: PLACEBO plus SOC
Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Other: Standard of Care
- Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52 [ Time Frame: At week 52 ]
A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline.
The decrease of 4 points of the SRI is considered as better ouctome.
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): NCT02504645
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|Principal Investigator:||Daniel WALLACE||Wallace Rheumatic Studies Center LLC|