Study of VIB7734 for the Treatment of Moderate to Severely Active SLE (RECAST SLE)
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ClinicalTrials.gov Identifier: NCT04925934 |
Recruitment Status :
Completed
First Posted : June 14, 2021
Last Update Posted : February 28, 2024
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
Tracking Information | |||||
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First Submitted Date ICMJE | May 4, 2021 | ||||
First Posted Date ICMJE | June 14, 2021 | ||||
Last Update Posted Date | February 28, 2024 | ||||
Actual Study Start Date ICMJE | June 24, 2021 | ||||
Actual Primary Completion Date | May 16, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48 [ Time Frame: Week 48 ] Participants will have BICLA (BILAG 2004 Index-Based Combined Lupus Assessment) and oral glucocorticoid assessment at week 48.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
Number of Participants who experience AEs, SAEs, AESIs [ Time Frame: Baseline through Week 56 ] Safety evaluation will occur throughout the study.
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Original Other Pre-specified Outcome Measures |
Number of Participants who experience AEs, SAEs, AESIs [ Time Frame: Baseline through Week 60 ] Safety evaluation will occur throughout the study.
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Descriptive Information | |||||
Brief Title ICMJE | Study of VIB7734 for the Treatment of Moderate to Severely Active SLE | ||||
Official Title ICMJE | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus | ||||
Brief Summary | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, double-blind, placebo-controlled, parallel-arm study Masking: Double (Participant, Investigator)Primary Purpose: Treatment |
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Condition ICMJE | Lupus Erythematosus, Systemic | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
214 | ||||
Original Estimated Enrollment ICMJE |
195 | ||||
Actual Study Completion Date ICMJE | June 9, 2023 | ||||
Actual Primary Completion Date | May 16, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Have at least one of the following at Screening per central lab:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Argentina, Greece, India, Mexico, Poland, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04925934 | ||||
Other Study ID Numbers ICMJE | VIB7734.P2.S1 2020-005528-12 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Amgen | ||||
Original Responsible Party | Viela Bio | ||||
Current Study Sponsor ICMJE | Amgen | ||||
Original Study Sponsor ICMJE | Viela Bio | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Amgen | ||||
Verification Date | July 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |