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Rheumatoid ArthritisPhase 1NCT02176876

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

A Phase 1 study testing GS-5745 in people with Rheumatoid Arthritis, run by Gilead Sciences at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
GS-5745
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
4 sitesin 2 countries
Study dates
Aug 2014to Jun 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Hungary3 sites

  • Study site

    Balatonfüred, Veszprém megye

  • Study site

    Budapest

  • Study site

    Debrecen

Other trials in Hungary

Czechia1 site

  • Study site

    Prague

Other trials in Czechia

About this study

Official 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

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.

Being tested
GS-5745, Placebo to match GS-5745
Keywords
rheumatoid arthritis, RA, GS-5745, MMP9, phase 1
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GS-5745Drug

    GS-5745 400 mg administered intravenously

  • Placebo to match GS-5745Drug

    Placebo to match GS-5745 administered intravenously

Study groups in NCT02176876
Study groupRoleWhat they receive
GS-5745ExperimentalParticipants will receive GS-5745 every 2 weeks for a total of 3 infusions.
Receives: Drug: GS-5745
Placebo to match GS-5745Placebo comparatorParticipants will receive placebo to match GS-5745 every 2 weeks for a total of 3 infusions.
Receives: Drug: Placebo to match GS-5745

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 100 days

Secondary outcomes (1)

  1. PK profile of GS-5745

    This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:

    • Cmax: maximum observed concentration of drug in plasma
    • Tmax: time of Cmax
    • Clast: last observable concentration of drug
    • Tlast: time of Clast
    • AUClast: concentration of drug from time zero to the last quantifiable concentration
    • AUCinf: concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time)
    • AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)
    • Ctau: observed drug concentration at the end of the dosing interval
    • λz: terminal elimination rate constant
    • CL: systemic clearance of the drug following intravenous administration
    • Vz: volume of distribution of the drug following intravenous administration

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionApr 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02176876
Sponsor's protocol ID
GS-US-373-1276
Other IDs
2013-005396-41
Status last verified
Jun 2015
First submitted
25 Jun 2014
Last updated
29 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29287749

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GS-5745 in people with Rheumatoid Arthritis, run by Gilead Sciences at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Hungary, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02176876, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.

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