Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis

A Blinded, Placebo-controlled, Study of the Safety and Pharmacokinetics of XOMA 052 Administered to Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis

Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to patients with active, stable, moderate to severe rheumatoid arthritis (RA).

It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control in subjects with RA.

Study Overview

• Status: Suspended
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: XOMA 052; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33765
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American College of Rheumatology (ACR) diagnostic criteria for RA
• Moderate to severe disease, defined as follows - At least six tender and six swollen joints (28 joint count) AND ESR > 28 mm/hr or CRP > 1.0 mg/dL
• Current duration of RA at Screening ≥ 6 months and ≤ 20 years
• RA and other medical conditions must be stable.
• Age ≥ 18 and ≤ 75 at Screening
• Weight ≥ 80 lbs (36.3 kg) and ≤ 275 lbs (125.0 kg)
• For females with child-bearing potential, a negative serum pregnancy test

Exclusion Criteria:

• Major surgery within 28 days prior to Day 0
• Joint replacement surgery within 60 days prior to Day 0 or joint replacement surgery planned within 9 months following Day 0
• Known HIV antibody, or hepatitis B surface antigen
• History of malignancy within 5 years prior to Screening other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
• Immunodeficiency
• History or symptoms of a demyelinating disease
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 < 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
• History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma. A subject who has had a positive PPD test but has completed a course of treatment for tuberculosis, had a documented vaccination against tuberculosis, or had a negative QuantiFERON -TB test result is eligible.
• Chronic obstructive pulmonary disease (COPD), asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily
• Significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis)
• Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function. If the diagnosis of liver disease was based on positive Hep C serology due to prior vaccination, the subject is eligible.
• Pregnant or planning to become pregnant during the course of the study, or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: Placebo; A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
Active Comparator: 1	Drug: XOMA 052; A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.	Day 0 pre-dose through Day 56

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.	Day 0 Pre-dose through Day 56
Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.	Day 0 pre-dose through Day 56
Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol.	Day 0 pre-dose through Day 56

Collaborators and Investigators

• Sponsor: XOMA (US) LLC
• Investigators: Study Director: Alan Solinger, M.D., XOMA (US) LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 17, 2008
• First Submitted That Met QC Criteria: October 20, 2008
• First Posted (Estimate): October 22, 2008

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Arthritis; Rheumatoid
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: X052070