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New treatment option for Rheumatoid Arthritis
Official title Study of GS-0151 in Participants With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06902519
What this study is testing
What is GS-0151?
GS-0151 is an investigational medicine, being studied as a potential treatment for rheumatoid arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Key Medical History/Physical Characteristics; All Cohorts:
- Individuals must not be on a biologic disease-modifying antirheumatic drug (b/tsDMARD) on Day 1 and must have discontinued all b/tsDMARDs (including...
- Ongoing treatment with at least 1 but no more than 2 protocol-permitted conventional synthetic disease-modifying antirheumatic drug (csDMARDs) for at...
- Use of oral, intramuscular (IM), or subcutaneous(ly) (SC) methotrexate 7.5 to 25 mg/week. Individuals on methotrexate must be receiving folic or...
- Oral hydroxychloroquine ≤ 400 mg/day or chloroquine ≤ 250 mg/day.
You likely can't join if
- Medical Conditions; All Cohorts:
- Have a diagnosis of any generalized musculoskeletal disorder that would interfere with study procedures or assessments per the discretion of the...
- History of opportunistic infection or immunodeficiency syndrome that would put the individual at risk, as per investigator's judgment.
- Active infection that is clinically significant, per investigator's judgment, or any infection requiring hospitalization or treatment with...
- History of or current moderate to severe congestive heart failure (New York Heart Association class III or IV), or within the last 6 months prior to...
- History of lymphoproliferative disease or possible current lymphoproliferative disease.
See the full eligibility criteria
Who can join
- Key Medical History/Physical Characteristics; All Cohorts:
- Individuals must not be on a biologic disease-modifying antirheumatic drug (b/tsDMARD) on Day 1 and must have discontinued all b/tsDMARDs (including biosimilars and generics) at least 4 weeks prior to Day 1 with the...
- Ongoing treatment with at least 1 but no more than 2 protocol-permitted conventional synthetic disease-modifying antirheumatic drug (csDMARDs) for at least 12 weeks, at a stable dose for at least 6 weeks prior to Day 1...
- 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.
- Oral hydroxychloroquine ≤ 400 mg/day or chloroquine ≤ 250 mg/day.
- Oral sulfasalazine 1 to 3 g/day.
- Oral leflunomide 10 to 20 mg/day.
- Use of oral corticosteroids of no more than 10 mg prednisone or equivalent per day is allowed if the dose is stable for at least 14 days prior to Day 1. Inhaled corticosteroids for stable medical conditions are allowed...
- Where nonsteroidal anti-inflammatory drug (NSAIDs) or acetaminophen are used, the dose must be stable for at least 1 week prior to Day 1
- Individuals must have discontinued all high-potency opiates at least 1 week prior to Day 1. Cohort 3 Only:
- Individuals must meet all of the following cohort-specific , in addition to meeting the for all individuals , to be eligible for participation in Part B: Moderately to severely active RA defined by the following...
- 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. Screening Only
- Have a hsCRP ≥ ULN
- Inadequate response or intolerance to at least 1 but no more than 3 b/tsDMARDs with no more than 2 mechanisms of action. A lack of response is defined as documented continued or recurrent disease activity after at least...
- Anti-cyclic citrullinated peptide antibody (Anti-CCP) positive and/or rheumatoid factor (RF) positive Key
What rules you out
- Medical Conditions; All Cohorts:
- Have a diagnosis of any generalized musculoskeletal disorder that would interfere with study procedures or assessments per the discretion of the investigator.
- History of opportunistic infection or immunodeficiency syndrome that would put the individual at risk, as per investigator's judgment.
- Active infection that is clinically significant, per investigator's judgment, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 60 days of screening; or any infection...
- History of or current moderate to severe congestive heart failure (New York Heart Association class III or IV), or within the last 6 months prior to screening.
- History of lymphoproliferative disease or possible current lymphoproliferative disease.
- History of organ or bone marrow transplant.
- Have a history of major surgery (requiring regional block or general anesthesia) within the last 12 weeks prior to screening or planned major surgery during the study.
- History of an infected joint prosthesis or other implanted device with the prosthesis or device still in situ.
- Clinically significant ECG abnormalities at screening, including electrocardiographic interval between the beginning of the Q wave and termination of the T wave, representing the time for both ventricular depolarization...
- Administration of a live attenuated vaccine 4 weeks prior to Day 1 or planned throughout the study.
- Participation in any investigational drug/device clinical study within 4 weeks or 5 half-lives prior to screening, whichever is longer. Exposure to investigational biologics should be discussed with the sponsor...
- Any positive tuberculosis (TB) test using interferon-gamma release assay (IGRA) performed by central laboratory at screening. Tests with inconclusive results may be repeated one time. If an inconclusive test is repeated...
- Evidence of active hepatitis C virus (HCV) infection. Individuals with positive HCV Ab at screening require reflex testing for HCV ribonucleic acid (RNA). Individuals with positive HCV Ab but negative HCV RNA viral load...
- The results of the following laboratory tests performed at the central laboratory at screening meet any of the criteria below (out-of-range laboratory values may be rechecked 1 time, per investigator's judgment, before...
- 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)
- Neutrophils \< 1.5 x 10\^3 cells/mm\^3 (SI: \< 1.5 x 10\^9 cells/L)
- Lymphocytes \< 1.0 x 10\^3 cells/mm\^3 (SI: \< 1.0 x 10\^9 cells/L)
- Platelets \< 100 x 10\^3 cells/mm\^3 (SI: \< 100 x 10\^9 cells/L)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 x upper limit of normal (ULN)
- Total bilirubin level ≥ 2 x ULN unless the individual has been diagnosed with Gilbert's disease and this is clearly documented
- Creatinine clearance \< 50 mL/min (SI: \< 0.83 mL/s) based on the Cockcroft-Gault formula Note: Other protocol defined Inclusion/Exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Anniston, Alabama, United States
- La Jolla, California, United States
- Palo Alto, California, United States
- Tujunga, California, United States
- Whittier, California, United States
- Clearwater, Florida, United States
- Chicago, Illinois, United States
- Lake Charles, Louisiana, United States
- Oklahoma City, Oklahoma, United States
- Duncansville, Pennsylvania, United States
- Baytown, Texas, United States
- Colleyville, Texas, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Mesquite, Texas, United States
- San Antonio, Texas, United States
- Tomball, Texas, United States
- Virginia Beach, Virginia, United States
- Tbilisi, Georgia
- Cologne, Germany
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anniston, Alabama, United States; La Jolla, California, United States; Palo Alto, California, United States; Tujunga, California, United States; Whittier, California, United States; Clearwater, Florida, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.