Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 99 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Judith Falloon, MD|
|Principal Investigator Affiliation||Viela Bio|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Poland, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
The overall study period will be approximately 337 days. After a screening period of up to 28 days, the participants will be randomized in a 1:1:1:1:1 ratio to receive intravenous dose of VIB4920 and/or placebo in 5 cohorts. Participants are to be followed on their stable background anti-rheumatoid arthritis (RA) therapy at least through 12 weeks (Day 85), at which time rescue therapy may be instituted. All participants will be followed at least through the primary (interim) analysis (Day 113), and those who have not instituted rescue therapy will be followed through Day 309 to determine the duration of clinical response. The primary analysis will be after all participants have completed Day 113, and the final analysis will be after all participants have completed follow-up.
Experimental: VIB4920 Dose1 (dosing interval 1)
Participants will receive intravenous (IV) infusion of VIB4920 Dose1 in dosing interval 1.
Experimental: VIB4920 Dose1 (dosing interval 2)+Placebo (dosing interval 3)
Participants will receive IV infusion of VIB4920 Dose1 in dosing interval 2 and placebo matched to VIB4920 in dosing interval 3.
Experimental: VIB4920 Dose2 (dosing interval 2)+Placebo (dosing interval 3)
Participants will receive IV infusion of VIB4920 Dose2 in dosing interval 2 and placebo matched to VIB4920 in dosing interval 3.
Experimental: VIB4920 Dose2 (dosing interval 4)+Placebo (dosing interval 5)
Participants will receive IV infusion of VIB4920 Dose2 in dosing interval 4 and placebo matched to VIB4920 in dosing interval 5.
Placebo Comparator: Placebo (dosing interval 1)
Participants will receive IV infusion of placebo matched to VIB4920 in dosing interval 1.
Drug: - VIB4920
VIB4920 Dose 1 or 2 will be administered intravenously per dosing interval of 1 or 2 or 4.
Drug: - Placebo
Placebo will be administered intravenously per dosing interval of 1 or 3 or 5.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.