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Study terminated due to lack of efficacy.
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The goals of this clinical study are to learn more about the study drug, GS-0272, and its safety and tolerability following multiple doses in participants with rheumatoid arthritis (RA).
The primary objectives of this study are to assess the safety and tolerability of multiple ascending doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple doses of GS-0272, in participants with RA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo | Experimental | Part A will include participants with RA. Part A will have 3 cohorts. Each cohort in Part A will be randomized in a 3:1 ratio to receive either ascending doses of GS-0272 or placebo for 12 weeks. Dosing will begin in Cohort 1. Cohorts 2 and 3 will be initiated upon review of blinded safety data from the preceding cohort. |
|
| Part B: Active RA Cohort: GS-0272 or Placebo | Experimental | Part B will include participants with moderate-to-severe RA. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 2:1 ratio to receive either GS-0272 or placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-0272 | Drug | Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Adverse Events (AEs) | First dose up to Week 12 plus 70 days | |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) | First dose up to Week 12 plus 70 days | |
| Percentage of Participants With Laboratory Abnormalities | First dose up to Week 12 plus 70 days | |
| Pharmacokinetics (PK) of GS-0272: AUCtau | AUCtau is defined as the area under the concentration versus time curve over the dosing interval. | Day 1 predose through Day 197 |
| PK of GS-0272: Cmax | Cmax is defined the maximum observed plasma drug concentration. | Day 1 predose through Day 197 |
| PK of GS-0272: Tmax | Tmax is defined as the time to maximum observed concentration. | Day 1 predose through Day 197 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Antidrug Antibodies (ADAs) for GS-0272 | Prevalence of ADAs will be measured as the proportion of participants who had at least one positive ADA sample (baseline or post-baseline) among all participants evaluable for ADA prevalence. | Baseline (Day 1) through Day 197 |
| Incidence of ADAs for GS-0272 |
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Key Inclusion Criteria:
Part A (Rheumatoid Arthritis (RA) Cohorts)-Specific Inclusion Criteria:
Part B (Active RA Cohort)-Specific Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates P.C. | Glendale | California | 85306 | United States | ||
| Stanford School of Medicine, Division of Immunology & Rheumatology |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Placebo | Drug | Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B) |
|
ADA incidence will be measured as the proportion of participants who have treatment-emergent ADA sample (post-baseline) among all participants evaluable for ADA incidence. |
| Baseline (Day 1) through Day 197 |
| Part B: Change from Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) in Participants with Moderate-to-Severe RA | Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. | Baseline, Week 12 |
| Palo Alto |
| California |
| 94304 |
| United States |
| 1238 E. Arrow Hwy | Upland | California | 91786 | United States |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Greater Chicago Specialty Physicians/ Clinical Investigation Specialists | Niles | Illinois | 60714 | United States |
| Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc. | Schaumburg | Illinois | 60195 | United States |
| Summit Headlands LLC | Portland | Oregon | 97210 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| PA Regional Center for Arthritis and Osteoporosis Research | Wyomissing | Pennsylvania | 19610 | United States |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | United States |
| Accurate Clinical Research, Inc. | Houston | Texas | 77089 | United States |
| Precision Comprehensive Clinical Research Solutions | Irving | Texas | 75061 | United States |
| 1600 Republic Parkway | Mesquite | Texas | 75150 | United States |
| ARENSIA Exploratory Medicine LLC | Tbilisi | 0112 | Georgia |
| IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M. | Chisinau | MD-2025 | Moldova |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Seoul National University Hospital | Seoul | 110 744 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| University Hospitals Coventry & Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Simbec Research Limited | Merthyr Tydfil | CF48 4DR | United Kingdom |
| NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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