A Phase 1b study of MEDI4920 in Subjects with Adult-onset Rheumatoid Arthritis - MEDI4920 in RA
Study identifier:D5100C00002
ClinicalTrials.gov identifier:NCT02780388
EudraCT identifier:2015-005318-30
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects with Adult-onset Rheumatoid Arthritis
Medical condition
adult onset Rheumatoid arthritis
Phase
Phase 1
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
57
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 12 May 2016
Primary Completion Date: 21 May 2018
Study Completion Date: 09 Aug 2018
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2019 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
Study transferred to VelaBio
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1 Medi4920 (CD40L antagonist) | Biological/Vaccine: MEDI4920 MEDI4920 CD40L |
| Placebo Comparator: Placebo Saline | Other: Placebo 0.9% saline for injection |
| Experimental: Cohort 2 Medi4920 (CD40L antagonist) | Biological/Vaccine: MEDI4920 MEDI4920 CD40L |
| Experimental: Cohort 3 Medi4920 (CD40L antagonist) | Biological/Vaccine: MEDI4920 MEDI4920 CD40L |
