Study of GS-0151 in Participants With Rheumatoid Arthritis (NCT06902519) | Clinical Trial Compass
RecruitingPhase 1
Study of GS-0151 in Participants With Rheumatoid Arthritis
United States75 participantsStarted 2025-05-14
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 6 or more tender joints on the tender joint count based on 68 joints (TJC68), AND.
✓. 6 or more swollen joints on the swollen joint count based on 66 joints (SJC66). The distal interphalangeal joints should be evaluated but not included in the total count to determine eligibility.
✓. Have a hsCRP ≥ ULN
Exclusion criteria
✕. Hemoglobin \< 10.0 g/dL (SI: \< 100 g/L)
✕. White blood cells \< 3.0 x 10\^3 cells/mm\^3 (SI: \< 3.0 x 10\^9 cells/L)
What they're measuring
1
Cohort 1, 2 and 3: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Up to Week 12
5
Cohorts 1, 2 and 3: Serum Cmax, Following the Last Dose of GS-0151
Timeframe: Up to Week 12
6
Cohorts 1, 2 and 3: Serum Tmax Following the Last Dose of GS-0151