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

This study is currently recruiting participants.
Verified March 2014 by Morphotek
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01357759
First received: May 18, 2011
Last updated: March 17, 2014
Last verified: March 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 ]

Estimated Enrollment: 19
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357759

Contacts
Contact: Bruce Wallin, MD (610) 423-6543 bwallin@MORPHOTEK.com

Locations
United States, California
Axis Clinical Trials Recruiting
Los Angeles, California, United States, 90036
Contact: Carlos Lopez, CRC    310-289-8242    crc5a@axistoday.com   
Contact: Maximo Tacuchi, CRC    310-289-8242    crc10@axistoday.com   
Principal Investigator: Lydie L Hazan, MD         
United States, Florida
Seaview Jacksonville, LLC Recruiting
Jacksonville, Florida, United States, 32256
Contact: Pamela E. Alpert, CCRC    904-730-4740 ext 5077    palpert@seaviewjax.net   
Contact: Jonalynn Birnbaum    305.649.6556    JBirnbaum@SeaViewResearch.Net   
Principal Investigator: Chrysoula Pappa, MD         
United States, Oklahoma
Lynn Health Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Kathi Shaw    405-602-3926    kshaw@lhsi.net   
Contact: April Green    405.601.3808.    agreen@lhsi.net   
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Tracey Madonna, CCRC    814-693-0300 ext 147    Traceymadonna1125@yahoo.com   
Contact: Brenda Earnest, CCRC    814 693 0300 ext 202    Brendaearnest1125@yahoo.com   
Principal Investigator: Alan J Kivitz, MD         
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: March 17, 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 April 15, 2014