Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis

Amgen

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Rozibafusp Alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT03156023

2017-000337-31 (EudraCT Number)

20150196

Details and patient eligibility

About

A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA).

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body Mass Index: 18-35 kg/m^2
• 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

• Uncontrolled, clinically significant systemic disease other than RA (i.e., diabetes mellitus, liver disease, asthma, cardiovascular disease, hypertension)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Rozibafusp Alfa

Experimental group

Description:

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).

Treatment:

Drug: Rozibafusp Alfa

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo to rozibafusp alfa administered subcutaneously once every 2 weeks for up to 10 weeks (6 doses).

Treatment:

Drug: Placebo