Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects

• ClinicalTrials.gov Identifier: NCT01357759
• Recruitment Status: Completed
• First Posted: May 23, 2011
• Last Update Posted: November 16, 2015
• Sponsor: Morphotek
• Information provided by (Responsible Party): Morphotek

Tracking Information

• First Submitted Date: May 18, 2011
• First Posted Date: May 23, 2011
• Last Update Posted Date: November 16, 2015
• Study Start Date: May 2013
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 12, 2015): Safety to measures to include adverse events, clinical laboratory results, vital signs, ECGs, physical examinations, local tolerability at the infusion site single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with RA. [ Time Frame: Approximately 113 days ]
• Original Primary Outcome Measures (submitted: May 19, 2011): Safety to measures to include adverse events, clinical laboratory results, vital signs, ECGs, physical examinations, local tolerability at the infusion site single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with RA. [ Time Frame: 88-113 days ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis
• Brief Summary: This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine the safety and tolerability of MORAb-022.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis

Intervention

Drug: MORAb-022

IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)

Study Arms

• Experimental: Escalating doses of MORAb-022
  Subjects with RA will be randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo).
  Intervention: Drug: MORAb-022
• Placebo Comparator: Placebo
  Subjects with RA will be also randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo).
  Intervention: Drug: MORAb-022

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 15, 2014): 20
• Original Estimated Enrollment (submitted: May 19, 2011): 60
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria for Rheumatoid Arthritis (RA) Subjects:

• Male or female subjects age greater than or equal to 18 years and less than or equal to 75 years.
• Subjects with RA diagnosis per the 2010 Rheumatoid Arthritis Classification Criteria per American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR.)
• BMI less than or equal to 35 kg/m2 at Screening.
• Active RA characterized by DAS28 score of less than or equal to 5.1 at Screening.
• Have been stabilized on their current dose (up to 25 mg/week) of methotrexate(MTX) for at least 4 weeks before randomization.

Exclusion Criteria for Rheumatoid Arthritis (RA)Subjects:

• Subjects with severe active RA and are not on a stable therapeutic regimen at Screening.
• Subjects without significant articular RA.
• Relevant history of significant respiratory disease (e.g., chronic bronchitis, asthma in last 5 years, chronic obstructive pulmonary disease, tuberculosis, interstitial lung disease, such as pneumonitis and pulmonary alveolar proteinosis, as well as significant inhalation exposure to silicon and other substances) that required treatment and/or follow up under the direction of a physician.
• Presence of GM-CSF autoantibodies above normal at Screening.
• Abnormal chest x-ray or PFTs as judged by the investigator at Screening as clinically significant.
• Positive Quantiferon test.
• History of clinically relevant hypersensitivity reactions (e.g., to gold therapy)
• History of medication use that might have carryover effects during the study.
• Previous administration of a GM-CSF modulator within 6 months of randomization, or previous administration of a monoclonal antibody or immunoglobulin fusion protein that is not (or worded as "other than") a GM-CSF modulator within 3 months of randomization.
• Use of any biological therapy other than the test article during the study (informed consent to termination visit)
• Subjects who consume greater than 14 alcoholic drinks per week for males or 7 alcoholic drinks per week for females.
• Weight greater than 120 kg at Screening.
• Use of parenteral and/or intra-articular steroids, immunosuppressants, investigational drugs, and oral anticoagulant drugs within 4 weeks prior to randomization. Oral steroid treatment is permitted if the dosage is less than or equal to 10 mg of prednisone daily, is stable for a minimum of 4 weeks before the study and remains unchanged throughout the study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands, United States

Administrative Information

• NCT Number: NCT01357759
• Other Study ID Numbers: MORAB022-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Morphotek
• Original Responsible Party: Joe Mercer, Ph.D, Eisai, Inc
• Current Study Sponsor: Morphotek
• Original Study Sponsor: Eisai Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alan J. Kivitz, MD, CPI; Altoona Center for Clinical Research
• Principal Investigator: Lydie Hazan, MD; Axis Clinical Trials
• Principal Investigator: Chrysoula Pappa, MD; Seaview Jacksonville, LLC
• Principal Investigator: William M Schnitz, MD; Lynn Health Science Institute

• PRS Account: Morphotek
• Verification Date: November 2015