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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT03156023
• Date of registration: 15/05/2017
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis
• Scientific title: A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis
• Date of first enrolment: August 14, 2017
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03156023
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Germany, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo

Drug: Rozibafusp Alfa

Primary Outcome(s)

Number of Participants With Treatment-emergent Adverse Events [Time Frame: From first dose of study drug to 24 weeks after last dose (up to 34 weeks).]

Secondary Outcome(s)

Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Rozibafusp Alfa [Time Frame: Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.]

Maximum Observed Serum Concentration (Cmax) of Rozibafusp Alfa [Time Frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.]

Area Under the Concentration-time Curve From 0 to 14 Days Postdose (AUC0-tau) for Rozibafusp Alfa [Time Frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose.]

Terminal Half-life of Rozibafusp Alfa [Time Frame: Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.]

Accumulation Ratio of AUCtau [Time Frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose]

Accumulation Ratio of Cmax [Time Frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose]

Time to Maximum Observed Concentration (Tmax) of Rozibafusp Alfa [Time Frame: Day 1 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours post-dose. Week 10 predose and 6, 12, 24, 48, 72, 144, 168, and 336 hours and at 3, 4, 5, 6, 8, 10, and 12 weeks post-dose.]

Secondary ID(s)

2017-000337-31

20150196

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/04/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03156023