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

NCT ID: NCT01357759

Last Updated: 2015-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-07-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

MORAb-022

Intervention Type: DRUG

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

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).

Group Type: PLACEBO_COMPARATOR

MORAb-022

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morphotek

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan J. Kivitz, MD, CPI

Role: PRINCIPAL_INVESTIGATOR

Altoona Center for Clinical Research

Lydie Hazan, MD

Role: PRINCIPAL_INVESTIGATOR

Axis Clinical Trials

Chrysoula Pappa, MD

Role: PRINCIPAL_INVESTIGATOR

Seaview Jacksonville, LLC

William M Schnitz, MD

Role: PRINCIPAL_INVESTIGATOR

Lynn Health Science Institute

Locations

Axis Clinical Trials

Los Angeles, California, United States

Seaview Jacksonville, LLC

Jacksonville, Florida, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Pharmaceutical Research Associates Group B.V.

Zuidlaren, , Netherlands

Countries

United States; Netherlands

Other Identifiers

MORAB022-001

Identifier Type: -

Identifier Source: org_study_id