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A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
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
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
Start Date
December 13, 2018
Primary Completion Date
July 20, 2020
Completion Date
July 20, 2020
Last Updated
December 13, 2024
31
ACTUAL participants
VIB7734
DRUG
Placebo
DRUG
Lead Sponsor
Amgen
NCT06647069
NCT07371468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06333483