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Completed

NCT Number: NCT03156023

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

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charite Research Organisation GmbH, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rozibafusp Alfa

Drug

Administered by subcutaneous injection once every 2 weeks.

Other names: AMG 570

Placebo

Drug

Administered by subcutaneous injection once every 2 weeks.

Primary outcomes

  1. 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).

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and clinically significant changes in laboratory test results and physical exam findings. The event does not necessarily have a causal relationship with study treatment.

    AEs were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe or medically significant, Grade 4 = Life-threatening, and Grade 5 = Death.

    A serious adverse event is defined as an AE that met at least 1 of the following serious criteria:

    • fatal;
    • life threatening;
    • required in patient hospitalization or prolongation of existing hospitalization;
    • resulted in persistent or significant disability/incapacity;
    • congenital anomaly/birth defect;
    • other medically important serious event. The investigator assessed whether each AE was related to study drug.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 is the ratio of AUCtau after the last dosing interval (week 10) divided by AUCtau after the first dosing interval (day 1).

  7. 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

    Accumulation ratio is the ratio of Cmax after the last dosing interval (week 10) divided by Cmax after the first dosing interval (day 1).

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 16, 2017
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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