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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01357759
First received: May 18, 2011
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: MORAb-022
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: January 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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)
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).
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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357759

Locations
United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90036
United States, Florida
Seaview Jacksonville, LLC
Jacksonville, Florida, United States, 32256
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Morphotek
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
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01357759     History of Changes
Other Study ID Numbers: MORAB022-001
Study First Received: May 18, 2011
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014