Phase 1
Completed N=34
Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT03156023 ↗Enrolled (actual)
34
Serious AEs
5.9%
Results posted
Apr 2023
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events — 7; 6; 6; 6 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events |
7; 6; 6; 6; 7; 4 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of Rozibafusp Alfa |
3.0; 3.0; 4.5; 6.0; 3.0; 5.0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Rozibafusp Alfa |
2.56; 8.34; 13.7; 24.1; 6.85; 22.7 | — |
| SECONDARY Area Under the Concentration-time Curve From 0 to 14 Days Postdose (AUC0-tau) for Rozibafusp Alfa |
22.6; 86.2; 143; 265; 57.1; 284 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Rozibafusp Alfa |
107; 651; 1110; 2160 | — |
| SECONDARY Terminal Half-life of Rozibafusp Alfa |
4.62; 5.62; 6.68; 9.50 | — |
| SECONDARY Accumulation Ratio of AUCtau |
2.94; 3.55; 4.41; 4.27 | — |
| SECONDARY Accumulation Ratio of Cmax |
3.08; 3.00; 4.06; 3.71 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03156023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.