Testing GS-0272 for safety in rheumatoid arthritis patients

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

This study is testing a new drug called GS-0272 to see if it's safe for people with rheumatoid arthritis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Gilead Sciences (Industry-sponsored)
• Drugs / interventions: rituximab
• Locations: 16 sites (Glendale, California and 15 other locations)
• Trial ID: NCT06031415 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and tolerability of the investigational drug GS-0272 in participants diagnosed with rheumatoid arthritis. It involves administering multiple ascending doses of GS-0272 and assessing its pharmacokinetics. Participants will be monitored for any adverse effects and overall response to the treatment. The study is designed to gather important data that could inform future treatment options for rheumatoid arthritis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 to 75 with a diagnosis of rheumatoid arthritis for at least three months who are currently on stable doses of specific conventional synthetic disease-modifying antirheumatic drugs.

Not a fit: Patients currently using biologic or targeted synthetic disease-modifying antirheumatic drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with rheumatoid arthritis.

How similar studies have performed: Other studies have shown promise in evaluating new treatments for rheumatoid arthritis, but the specific approach of GS-0272 is novel.

Eligibility criteria

Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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.

Where this trial is running

Glendale, California and 15 other locations

• Arizona Arthritis & Rheumatology Associates P.C. — Glendale, California, United States (Recruiting)
• Stanford School of Medicine, Division of Immunology & Rheumatology — Palo Alto, California, United States (Recruiting)
• 1238 E. Arrow Hwy — Upland, California, United States (Recruiting)
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States (Recruiting)
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Recruiting)
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States (Active_not_recruiting)
• Accurate Clinical Research, Inc. — Houston, Texas, United States (Recruiting)
• 1600 Republic Parkway — Mesquite, Texas, United States (Recruiting)
• ARENSIA Exploratory Medicine LLC — Tbilisi, Georgia (Recruiting)
• Chungnam National University Hospital — Daejeon, Korea, Republic of (Recruiting)
• Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
• Ajou University Hospital — Suwon, Korea, Republic of (Recruiting)
• IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M. — Chisinau, Moldova, Republic of (Recruiting)
• Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital — Cambridge, United Kingdom (Recruiting)
• Kings College Hospital — London, United Kingdom (Recruiting)
• NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust — Southampton, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Gilead Clinical Study Information Center

Conditions Rheumatoid Arthritis