NCT02176876

Brief Summary

This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple infusions of GS-5745 in adults with rheumatoid arthritis (RA). Participants will be randomized in a 4:1 ratio to receive 1 intravenous (IV) infusion of GS-5745 or placebo every 2 weeks, for a total of 3 IV infusions.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Aug 2014

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

June 25, 2014

Last Update Submit

June 25, 2015

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisRAGS-5745MMP9phase 1

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events, changes in laboratory tests and vital signs from baseline, and development of immunogenicity after dosing

    This composite endpoint will measure the safety and tolerability profile of GS-5745.

    Up to 100 days

Secondary Outcomes (1)

  • PK profile of GS-5745

    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

Study Arms (2)

GS-5745

EXPERIMENTAL

Participants will receive GS-5745 every 2 weeks for a total of 3 infusions.

Drug: GS-5745

Placebo to match GS-5745

PLACEBO COMPARATOR

Participants will receive placebo to match GS-5745 every 2 weeks for a total of 3 infusions.

Drug: Placebo to match GS-5745

Interventions

GS-5745DRUG

GS-5745 400 mg administered intravenously

GS-5745
Placebo to match GS-5745DRUG

Placebo to match GS-5745 administered intravenously

Placebo to match GS-5745

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Balatonfüred, Veszprém megye, Hungary

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Debrecen, Hungary

Location

Related Publications (1)

  • Gossage DL, Cieslarova B, Ap S, Zheng H, Xin Y, Lal P, Chen G, Smith V, Sundy JS. Phase 1b Study of the Safety, Pharmacokinetics, and Disease-related Outcomes of the Matrix Metalloproteinase-9 Inhibitor Andecaliximab in Patients With Rheumatoid Arthritis. Clin Ther. 2018 Jan;40(1):156-165.e5. doi: 10.1016/j.clinthera.2017.11.011. Epub 2017 Dec 26.

    PMID: 29287749DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

andecaliximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • David Gossage, MD

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 27, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations

CZ(1)HU(3)