Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis

September 29, 2016 updated by: MedImmune LLC

A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis

This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
    • Texas
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be able to provide written informed consent
  • Body mass index 18.5 to 35.0 kg/m2
  • Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
  • Global Functional Class I, II, or III according to ACR 1991 revised criteria

  • Stable use of >/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for >/= 4 weeks prior to Day 0, including:

    1. Methotrexate (MTX) 7.5 - 25 mg/week
    2. Hydroxychloroquine (HCQ) </= 400 mg/day
    3. Sulfasalazine (SSZ) 1,000 - 3,000 mg/day
    4. Leflunomide 5 - 20 mg/day
    5. Azathioprine 150 mg/day or 2 mg/kg/day
    6. Combinations of MTX, HCQ, and/or SSZ allowed

Exclusion Criteria:

  • Prior to Day 0, use of

    1. Abatacept
    2. Rituximab within 6 months
    3. Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months
    4. Etanercept or Anakinra within 28 days
    5. Immunoglobulin or blood products within 28 days
  • Evidence of any active or recent infection including ongoing, chronic infectious disease such as chronic renal infection or chronic chest infection with bronchiectasis or sinusitis
  • History of systemic autoimmune disease other than Rheumatoid Arthritis
  • History of allergic reactions to other protein therapeutics such as monoclonal antibodies or fusion proteins
  • History of anaphylaxis or allergic diathesis
  • Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
  • Evidence of active or latent tuberculosis
  • Vaccination wtih live attenuated viruses within the 2 weeks prior to Day 0
  • Evidence of infection with hepatitis B virus, hepatitis C virus, human immunodeficiency virus 1 or 2, or active infection with hepatitis A
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Dose levels 4 through 7: Single intravenous infusion on Day 0
Experimental: AMP-110
Escalating doses of AMP-110
Biological: AMP-110
Dose levels 1 through 7: Single intravenous infusion on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo
Time Frame: From start of study drug administration through Day 56
Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56)
From start of study drug administration through Day 56
Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials
Time Frame: From start of study drug administration through Day 56
Based on the occurrence of dose-limiting toxicities (through Day 14)
From start of study drug administration through Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate pharmacokinetic profile of a single dose of AMP-110
Time Frame: From Day 0 pre-dose through Day 28
Pharmacokinetics evaluated by area under the serum concentration versus time curve (AUC), peak serum concentration (Cmax), and clearance (Cl) of AMP-110
From Day 0 pre-dose through Day 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess pharmacokinetic and pharmacodynamic relationships
Time Frame: From Day 0 pre-dose through Day 56
Determine if pharmacodynamics effects of AMP-110 on certain cytokine levels and T cell subsets are dependent on serum drug concentrations
From Day 0 pre-dose through Day 56
Evaluate exploratory biomarkers
Time Frame: From start of study drug administration through Day 56
Blood samples will be analyzed throughout the study to characterize the physiological effects of AMP-110 treatment and to determine markers that correlate with response to treatment
From start of study drug administration through Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Collaborators

Daiichi Sankyo Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMP-110-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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