Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02176876
• Date of registration: 25/06/2014
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis
• Scientific title: A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis
• Date of first enrolment: August 2014
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02176876
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Czech Republic, Hungary

Contacts

• Name: David Gossage, MD
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 to 70 years of age, inclusive, at time of screening

- Weight: = 45 to < 120 kg

- Males or non-pregnant, non-lactating females

- Diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR)
for the classification of RA

- Active disease, defined as a mean high sensitivity C-reactive protein (hsCRP) value
from Visits 1 & 2 of = 8 mg/L

- Individuals taking chronic Disease-Modifying Antirheumatic Drugs (DMARDs) should be
on a stable dose for at least 45 days prior to randomization

- Chronic use of systemic corticosteroids up to a maximum of 10 mg/day of prednisone or
equivalent is allowed if dose is stable for at least 30 days prior to randomization

- Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or other analgesics are allowed if
doses are stable for at least 30 days prior to randomization

Exclusion Criteria:

- Have a document medical history of anaphylaxis

- Positive HIV antibody during screening

- Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antigen
(HBcAg), followed by a positive hepatitis B virus (HBV) DNA by quantitative
polymerase chain reaction (PCR) during screening

- Positive hepatitis C virus (HCV) antibody followed by a positive HCV viral RNA during
screening

- A positive QuantiFERON-tuberculosis (TB) GOLD test during screening

- History of malignancy within the last 5 years except for individuals who have been
treated locally for non-melanoma skin cancer or cervical carcinoma in situ

- Severe dementia or Alzheimer's disease, chronic medical or psychiatric problem, or
alcohol or drug abuse, that in the judgment of the investigator may interfere with
individual's ability to comply with study procedures

- Any serious cardiac event such as myocardial infarction, unstable or life-threatening
arrhythmia, hospitalization for cardiac failure within 6 months prior to
randomization or any significant or new ECG finding at Visit 1 as judged by the
investigator

- History of significant systemic involvement secondary to RA such as vasculitis,
pulmonary fibrosis, or Felty's syndrome

- History of or current inflammatory joint disease, other than RA, such as gout,
reactive arthritis, psoriatic arthritis, seronegative spondylarthritis, or Lyme
disease

- History of or current autoimmune or rheumatic disorders, other than RA, such as
systemic lupus erythematosus, inflammatory bowel disease, fibromyalgia, polymyalgia
rheumatic, scleroderma, inflammatory myopathy, mixed connective tissue disease, or
other overlap syndrome

- Any chronic medical condition (including, but not limited to, cardiac or pulmonary
disease) that, in the judgment of the investigator, would make the individual
unsuitable for the study or would prevent compliance with the study protocol

- Treatment with antibiotics for a clinical infection or other medical condition within
30 days prior to randomization

- Treatment with azathioprine or cyclosporine 90 days prior to randomization

- Treatment with infliximab, golimumab, adalimumab, abatacept, tocilizumab within 90
days; and etanercept or anakinra within 30 days of randomization

- Treatment with rituximab or any B-cell depleting agent within 12 months of
randomization

- Treatment with any other marketed or investigational biologic within 5 half-lives of
the molecule or if unknown within 90 days of randomization

- Administration of any investigational drug or use of any investigational device
within 30 days prior to randomization



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: GS-5745

Drug: Placebo to match GS-5745

Primary Outcome(s)

Incidence of adverse events, changes in laboratory tests and vital signs from baseline, and development of immunogenicity after dosing [Time Frame: Up to 100 days]

Secondary Outcome(s)

PK profile of GS-5745 [Time Frame: Pre-infusion, 30 minutes, 4 hours, and 24 hours post-infusion on Day 1; pre-infusion and 30 minutes post-infusion on Days 15 and 29; Days 4, 8, 36, and 43]

Secondary ID(s)

GS-US-373-1276

2013-005396-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors