Study of VIB7734 for the Treatment of Moderate to Severely Active SLE (RECAST SLE)
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|ClinicalTrials.gov Identifier: NCT04925934|
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : April 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic||Drug: VIB7734 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||195 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, placebo-controlled, parallel-arm study|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||June 24, 2021|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||October 1, 2023|
|Experimental: VIB7734 SC (dosing interval 1)||
|Experimental: VIB7734 SC (dosing interval 2)||
|Placebo Comparator: Placebo SC (dosing interval 3)||
- 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.
- Proportion of Participants with CLASI-A score ≥ 10 at Baseline (Day 1) who achieve ≥ 50% reduction from Baseline (Day 1) in CLASI-A score at Week 12 [ Time Frame: Week 12 ]Cutaneous Lupus Erythematosus Disease Area and Severity Index will be measured at week 12. The scoring consists of 2 parts: inflammatory activity of the disease and damage done by the disease.
- Proportion of Participants achieving an SRI-4 response and an OGC dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent at Week 48 [ Time Frame: Week 48 ]The SRI-4 (SLE Responder Index) is defined as meeting all criteria compared to baseline, (e.g. no worsening of symptoms).
- Proportion of Participants at OGC dose ≥ 10 mg prednisone or equivalent at Baseline (Day 1) who achieve an OCG of ≤ 7.5 mg/day prednisone or equivalent at Week 36 through Week 48 [ Time Frame: Week 36 to Week 48 ]
- Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48 [ Time Frame: Week 48 ]LLDAS is a composite measure of SLE disease activity that measures 5 criteria: SLEDAI-2K ≤ 4, with no activity in major organ systems, no new lupus disease activity, PGA ≤ 1 (scale 0 to 3), current prednisone (or equivalent) dose ≤ 7.5 mg daily, tolerated maintenance doses of immunosuppressive drugs and approved biological agents.
- Number of Participants who experience AEs, SAEs, AESIs [ Time Frame: Baseline through Week 60 ]Safety evaluation will occur throughout the study.
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): NCT04925934
|Contact: Horizon Therapeuticsemail@example.com|
|Study Director:||Rob Ortmann, MD||Horizon Therapeutics|