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Biologic Response Modifier

VIB1116 for Rheumatic Diseases

Phase 1
Waitlist Available
Research Sponsored by Viela Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 141
Awards & highlights

Study Summary

This trial is testing a new drug, VIB1116, to see if it is safe and tolerated in people with rheumatic diseases.

Eligible Conditions
  • Dendritic Cell-Mediated Rheumatic Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 141
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 141 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest
Secondary outcome measures
Change from baseline in the blood levels of plasmacytoid dendritic cells
Percentage of Participants who are ADA (antidrug antibody) positive
Serum concentration of VIB1116 and noncompartmental PK parameters
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VIB1116Experimental Treatment1 Intervention
Single dose of VIB1116, SC or IV administration. Multiple doses of VIB1116, SC administration.
Group II: PlaceboPlacebo Group1 Intervention
Single dose of Placebo, SC or IV administration. Multiple doses of Placebo, SC administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIB1116
2021
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Viela BioLead Sponsor
12 Previous Clinical Trials
1,056 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
898 Total Patients Enrolled
Suzy Hammel, MSHSStudy DirectorHorizon Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation allowed in this research project?

"The criteria for participation in this clinical trial necessitates that applicants are between 18 and 65 years of age. Patients younger than 18 have access to 9 studies, while those over 65 can partake in 36 different trials."

Answered by AI

What criteria must be satisfied in order to participate in this research project?

"This research endeavour is seeking 72 participants with collagen-related issues aged between 18 and 65. Their BMI must be lower than 30 kg/m², or for those who have received the COVID-19 vaccine in the last month their BMI must not exceed 35 kg/m^2. Additionally, they need to have been diagnosed with a rheumatologic disorder at least 6 months ago and had consistent treatment (or none) of glucocorticoid or DMARDs over the prior 4 weeks; finally, all involved parties are required to adhere to contraceptive protocols outlined by this study."

Answered by AI

How many individuals are permitted to participate in this trial?

"In order to effectively run this medical trial, 72 eligible candidates are required. The study is conducted from multiple research sites such as Accurate Clinical Research in Lake Charles and Pinnacle Research Group based in Anniston, Alabama."

Answered by AI

Are there still opportunities for individuals to take part in this experiment?

"Clinicaltrials.gov lists this clinical trial as currently open, with the original posting being on July 6th 2021 and its most recent edit occurring on September 22nd 2022."

Answered by AI

What can be determined about the safety of VIB1116 for human consumption?

"The safety profile of VIB1116 was ranked 1, as this is an initial phase trial that lacks substantial evidence for both efficacy and safety."

Answered by AI

Are there a great number of facilities conducting this experiment within the US?

"Currently, 8 medical centres are accepting patients for the trial. These sites include Lake Charles, Anniston and San Antonio plus 5 more locations across the country. It may be useful to prioritize nearby destinations when deciding on a test site in order to reduce travel commitments."

Answered by AI
~19 spots leftby Apr 2025