Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis
NCT ID: NCT03156023
Last Updated: 2024-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2017-08-14
2020-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rozibafusp Alfa
Participants will receive rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses). Rozibafusp alfa doses will range from 70 to 420 mg.
Escalation to a higher dose cohort will be contingent on a review indicating that the previous dose regimen has been found to demonstrate an acceptable safety and tolerability profile at a dose level review meeting (DLRM).
Rozibafusp Alfa
Administered by subcutaneous injection once every 2 weeks.
Placebo
Participants will receive matching placebo to rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses).
Placebo
Administered by subcutaneous injection once every 2 weeks.
Interventions
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Rozibafusp Alfa
Administered by subcutaneous injection once every 2 weeks.
Placebo
Administered by subcutaneous injection once every 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with RA (disease duration of at least 6 months)
* Stable dose of methotrexate (5-25 mg weekly for ≥ 4 weeks)
* Immunizations up to date
* Willing to use highly effective contraception during treatment and through end-of-study
Exclusion Criteria
* Malignancy within 5 years
* Presence of serious infection, recurrent/chronic infections
* Class IV RA according to American College of Rheumatology/ (ACR) revised response criteria
* Diagnosed with Felty's syndrome
* Known or suspected sensitivity to mammalian cell-derived products
* History of alcohol and/or substance abuse within the last 12 months
* Receipt of rituximab at any time in the past
* Evidence of renal disease
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Pinnacle Research Group LLC
Anniston, Alabama, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Charite Research Organisation GmbH
Berlin, , Germany
Countries
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References
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Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2017-000337-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20150196
Identifier Type: -
Identifier Source: org_study_id
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