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Biologic Response Modifier
A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases
Phase 1
Waitlist Available
Research Sponsored by Amgen
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 5 years
Summary
This trial is testing a new drug called VIB1116 to see if it is safe and well-tolerated in adults with rheumatic diseases. Researchers are giving the drug in different amounts to find the best dose.
Eligible Conditions
- Rheumatoid Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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?
AmgenLead Sponsor
1,466 Previous Clinical Trials
1,401,366 Total Patients Enrolled
49 Trials studying Rheumatoid Arthritis
109,779 Patients Enrolled for Rheumatoid Arthritis
Viela BioLead Sponsor
12 Previous Clinical Trials
1,031 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
78 Patients Enrolled for Rheumatoid Arthritis
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
873 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
78 Patients Enrolled for Rheumatoid Arthritis
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
945,167 Total Patients Enrolled
46 Trials studying Rheumatoid Arthritis
18,353 Patients Enrolled for Rheumatoid Arthritis
Suzy Hammel, MSHSStudy DirectorHorizon Therapeutics
Suzy HammelStudy DirectorHorizon Therapeutics