A Multicenter, Randomized, Placebo-Controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Ascending Doses of GS-0272 in Adult Participants With Rheumatoid Arthritis

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: SEQUENTIAL
• Masking: DOUBLE
• Enrollment: 55 participants

Interventions

• DRUG: GS-0272 — Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
• DRUG: Placebo — Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)

Primary Outcomes

• 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 (Day 1 predose through Day 197)
• PK of GS-0272: Cmax (Day 1 predose through Day 197)

Secondary Outcomes

• Prevalence of Antidrug Antibodies (ADAs) for GS-0272 (Baseline (Day 1) through Day 197)
• Incidence of ADAs for GS-0272 (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 (Baseline, Week 12)

Trial Locations

• Arizona Arthritis & Rheumatology Associates P.C., Glendale, California, United States
• Stanford School of Medicine, Division of Immunology & Rheumatology, Palo Alto, California, United States
• 1238 E. Arrow Hwy, Upland, California, United States
• Clinical Research of West Florida, Inc., Clearwater, Florida, United States
• Jacksonville Center for Clinical Research, Jacksonville, Florida, United States
• Greater Chicago Specialty Physicians/ Clinical Investigation Specialists, Niles, Illinois, United States
• Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc., Schaumburg, Illinois, United States
• Summit Headlands LLC, Portland, Oregon, United States
• Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States
• PA Regional Center for Arthritis and Osteoporosis Research, Wyomissing, Pennsylvania, United States
• ...and 10 more locations

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