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Study of GS-0151 in Participants With Rheumatoid Arthritis

ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGilead Sciences

About this trial

The goal of this clinical study is to learn more about the study drug GS-0151. The study is done to find how safe, well-tolerated the drug is. This will also assess how the drug is absorbed, modified, distributed and cleared from the body (the pharmacokinetics (PK) of the drug), when given multiple times to participants with rheumatoid arthritis (RA).

The primary objectives of this study is to assess the safety and tolerability of multiple ascending doses of GS-0151 in participants with RA and to characterize the PK of GS-0151 following multiple doses of GS-0151 in participants with RA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals must not be on a biologic disease-modifying antirheumatic drug (b/tsDMARD) on Day 1 and must have discontinued all b/tsDMARDs (including biosimilars and generics) at least 4 weeks prior to Day 1 with the exception of B cell-depleting agents (eg, rituximab), which must be discontinued for at least 6 months prior to Day 1.

Use of oral, intramuscular (IM), or subcutaneous(ly) (SC) methotrexate 7.5 to 25 mg/week. Individuals on methotrexate must be receiving folic or folinic acid supplementation at a stable dose.

Oral hydroxychloroquine ≤ 400 mg/day or chloroquine ≤ 250 mg/day.

Oral sulfasalazine 1 to 3 g/day.

Disqualifiers

Have a diagnosis of any generalized musculoskeletal disorder that would interfere with study procedures or assessments per the discretion of the investigator.

History of opportunistic infection or immunodeficiency syndrome that would put the individual at risk, as per investigator's judgment.

Active infection that is clinically significant, per investigator's judgment, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 60 days of screening; or any infection requiring oral anti-infective therapy within 30 days of screening.

History of or current moderate to severe congestive heart failure (New York Heart Association class III or IV), or within the last 6 months prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GS-0151

    Drug

    Administered for 12 weeks

  • Placebo

    Drug

    Administered for 12 weeks

Treatment groups

75 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A: Cohort 1 (GS-0151 Dose A)Experimental treatment 1 intervention
Group B: Part A: Cohort 1 (Placebo)Placebo comparator 1 intervention
Group C: Part A: Cohort 2 (GS-0151 Dose B)Experimental treatment 1 intervention
Group D: Part A: Cohort 2 (Placebo)Placebo comparator 1 intervention
Group E: Part B: Cohort 3 (GS-0151 Dose C)Experimental treatment 1 intervention
Group F: Part B: Cohort 3 (Placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Time frame
First dose up to 19 Weeks post end of treatment at Week 12
2

Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

Time frame
First dose up to 19 Weeks post end of treatment at Week 12
3

Cohorts 1, 2 and 3: Percentage of Participants Experiencing Serous Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Discontinuation

Time frame
First dose up to 19 Weeks post end of treatment at Week 12
4

Cohort 1, 2 and 3: Serum AUCtau Following the Last Dose of GS-0151

AUCtau is defined as the area under the serum concentration versus time curve over the dosing interval.

Time frame
Up to Week 12

Secondary outcomes

1

Cohorts 1, 2, and 3: Percentage of Participants with Antidrug Antibodies (ADAs) During the Study

Time frame
Up to Week 12
2

Cohort 3: Change From Baseline in Disease Activity Score for 28 Joint Count Using C-Reactive Protein (DAS28-CRP) at Week 12 in Participants With Moderately to Severely Active RA

The DAS28-CRP Score comprises tender joint count and swollen joint count based on a 28 joint assessment; patient's global assessment of disease activity and CRP. The DAS28-CRP Score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP=hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity.

Time frame
Baseline, Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
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