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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878123
• Other study ID #: AMP-110-01
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2013
• Last updated: September 29, 2016
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2016
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• AMP-110
Dose levels 1 through 7: Single intravenous infusion on Day 0

Other:
• Placebo
Dose levels 4 through 7: Single intravenous infusion on Day 0

Locations

Country	Name	City	State
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess pharmacokinetic and pharmacodynamic relationships	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	No
Other	Evaluate exploratory biomarkers	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	No
Primary	Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo	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	Yes
Primary	Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials	Based on the occurrence of dose-limiting toxicities (through Day 14)	From start of study drug administration through Day 56	Yes
Secondary	Evaluate pharmacokinetic profile of a single dose of AMP-110	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	No