The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis.
This study will have 3 periods: screening, treatment period, and extended follow-up. The screening period is 28 days. A total of 32 participants will be enrolled in 3 cohorts with 8 participants in Cohort 1, and 12 participants each in Cohorts 2 and 3. In Cohort 1, participants will be randomized in a 3:1 ratio to receive VIB7734 or matching placebo by injection every 4 weeks (q4w) for a total of 3 doses on Days 1, 29, and 57. In Cohorts 2 and 3, participants diagnosed with lupus only will be randomized in a 2:1 ratio to receive VIB7734 or matching placebo by injection q4w for 3 doses on Days 1, 29, and 57. Participants will be followed until at least Day 141. After the Day 141 visit, participants will exit the study if participants meets adequate plasmacytoid dendritic cells (pDCs). If an adequate pDC level does not meet at Day 141 visit, the participant will continue the follow-up for pDC repletion until they meet the protocol defined adequate pDC level or Day 337 visit has been reached. Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
31
Viela Bio Investigative Site
Anniston, Alabama, United States
Viela Bio Investigative Site
Birmingham, Alabama, United States
Viela Bio Investigative Site
Los Angeles, California, United States
Viela Bio Investigative Site
Upland, California, United States
Viela Bio Investigative Site
Danbury, Connecticut, United States
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 up to Day 337
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Day 1 up to Day 337
Number of Participants With Laboratory Abnormalities Reported as TEAEs
Time frame: Day 1 up to Day 337
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Time frame: Day 1 up to Day 337
Number of Participants With 12-Lead Electrocardiogram Abnormalities Reported as TEAEs
Time frame: Day 1 up to Day 337
Maximum Observed Serum Concentration (Cmax) of VIB7734 Maximum Observed Serum Concentration (Cmax) of VIB7734
Time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Area Under the Concentration-time Curve (AUC) of VIB7734
Time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Systemic Clearance (CL) of VIB7734
Time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Terminal Half-life (t1/2) of VIB7734
Time frame: Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253
Number of Participants With Positive Anti-Drug Antibodies of VIB7734
Time frame: Day 1 up to Day 309
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score (Cohorts 2 and 3)
Time frame: Day 1 up to Day 253
Blood Levels of pDCs
Time frame: Day 1 up to Day 337
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Viela Bio Investigative Site
Fort Lauderdale, Florida, United States
Viela Bio Investigative Site
Hialeah, Florida, United States
Viela Bio Investigative Site
Jacksonville, Florida, United States
Viela Bio Investigative Site
Miami Lakes, Florida, United States
Viela Bio Investigative Site
St. Petersburg, Florida, United States
...and 20 more locations