Study of GS-0272 in Participants With Rheumatoid Arthritis
- Registration Number
- NCT06031415
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 87
- Age limit for the Republic of Korea for male or nonpregnant female is between 19 and 75 years of age.
Part A (Rheumatoid Arthritis (RA) Cohorts)-Specific Inclusion Criteria:
- Diagnosis of RA at least 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.
- Ongoing treatment with 1 or 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for at least 12 weeks prior to the first dose of study drug, with a stable dose for at least 4 weeks prior to the first dose of study drug, as follows:
- Individuals must not be on a biologic disease-modifying antirheumatic drugs (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) at Day 1 or during the study and must discontinue b/tsDMARD use for at least 4 weeks (with the exception of rituximab, which must be discontinued for at least 16 weeks) prior to the first dose of study drug.
Part B (Active RA Cohort)-Specific Inclusion Criteria:
- Participant is seropositive as demonstrated by a positive anti-cyclic citrullinated peptide (anti-CCP) antibody and/or positive rheumatoid factor at screening.
- Participant has an elevated high-sensitivity C-reactive protein (hsCRP) greater than upper limit of normal (ULN).
- Participant has 6 or more swollen and 6 or more tender joints as assessed on the SJC66/TJC68. Distal interphalangeal joints will not be counted towards the 6 joint eligibility.
- Participant has had inadequate response or intolerance to at least 1 but not more than 3 bDMARD/tsDMARD therapeutics with no more than 2 MOAs. A lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA.
Key
- Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others).
- Inadequate response or intolerance to more than 3 bDMARDs/tsDMARDs with more than 2 MOAs.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo GS-0272 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 Placebo 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. Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo Placebo 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 GS-0272 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.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK) of GS-0272: AUCtau Day 1 predose through Day 197 AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Percentage of Participants Experiencing Adverse Events (AEs) First dose up to Week 12 plus 70 days PK of GS-0272: Cmax Day 1 predose through Day 197 Cmax is defined the maximum observed plasma drug concentration.
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 PK of GS-0272: Tmax Day 1 predose through Day 197 Tmax is defined as the time to maximum observed concentration.
- Secondary Outcome Measures
Name Time Method Prevalence of Antidrug Antibodies (ADAs) for GS-0272 Baseline (Day 1) through Day 197 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.
Incidence of ADAs for GS-0272 Baseline (Day 1) through Day 197 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.
Part B: Change from Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) in Participants with Moderate-to-Severe RA Baseline, Week 12 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.
Trial Locations
- Locations (16)
1238 E. Arrow Hwy
🇺🇸Upland, California, United States
Arizona Arthritis & Rheumatology Associates P.C.
🇺🇸Glendale, California, United States
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Stanford School of Medicine, Division of Immunology & Rheumatology
🇺🇸Palo Alto, California, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Accurate Clinical Research, Inc.
🇺🇸Houston, Texas, United States
1600 Republic Parkway
🇺🇸Mesquite, Texas, United States
ARENSIA Exploratory Medicine LLC
🇬🇪Tbilisi, Georgia
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
🇲🇩Chisinau, Moldova, Republic of
Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom