Proximod, a Selective Sphingosine-1-phosphate Receptor 1 Modulator in Patients With Moderate-to-s… (NCT07335952) | Clinical Trial Compass
CompletedPhase 2
Proximod, a Selective Sphingosine-1-phosphate Receptor 1 Modulator in Patients With Moderate-to-severe Active Rheumatoid Arthritis: a Double-blind, Randomised, Placebo-controlled, Phase 2 Trial.
China179 participantsStarted 2024-09-02
Plain-language summary
The goal of this multicenter, randomized, double-blind, placebo-controlled phase 2 clinical trial is to evaluate the efficacy and safety of proximod in active rheumatoid arthritis patients with inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). The main questions it aims to answer are:
Evaluate the efficacy of different doses of proximod in active RA patients who have inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), and provide a basis for dose selection in the confirmatory phase III clinical study.
Explore the changes of S1P and SPHK before and after treatment of proximod. Participants will take proximod 5mg/10mg daily or placebo for three months and will be followed up for 1 month.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients aged 18-70 years
✓. Diagnosed rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology- European League against Rheumatism classification criteria at least 3 months before screening.
✓. Have active RA as defined by ≥ 6 swollen joints (based on 66 joint counts) and ≥6 tender joints (based on 68 joint counts) at screening and baseline.
✓. High-sensitivity CRP concentrations equal to or exceeding the upper limit of normal value (ULN) or erythrocyte sedimentation rate (ESR) \> ULN
✓. Have an inadequate response to ≥ 1 csDMARDs, defined by moderate to high disease activity (DAS28 \>3.2, CDAI\>2.8, SDAI\>3.3).
Exclusion criteria
✕. An intra-articular or other injectable corticosteroid within 4 weeks prior to Screening
✕. Patients receiving daily corticosteroid treatment at a dosage \> 10 mg/day or with an unstable dose within four weeks before inclusion.If glucocorticoids have been discontinued, they should be stopped for at least 2 weeks before the first administration of the study drug.
What they're measuring
1
The proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 12.
. Those who are using non-steroidal anti-inflammatory drugs (except paracetamol) and whose dosage has not been stable within 4 weeks before the first administration of the study drug, or those who cannot continue to take the drug at the original stable dosage during the trial. If they have stopped taking the drug, they need to stop taking the drug for at least 2 days or 5 half-lives (whichever is longer) before the first administration of the study drug.
✕. Patients who have received treatment with Iguratimod, interferon (such as Roferon, Intron A, Rebetron, etc.), drugs known to have strong immunosuppressive or immunomodulatory effects (including total Glucosides of Paeony, Tripterygium wilfordii Hook.f, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, 6 - mercaptopurine, etc.), or technetium \[99Tc\] methylene diphosphonate injection within 4 weeks before the first administration of the study drug.
✕. Use of opioids within 4 weeks before the first administration of the study drug.
✕. Oral traditional Chinese medicines for the treatment of RA and other inflammatory diseases within 4 weeks before the first administration of the study drug.
✕. Subjects who have received integrin Alpha V antibodies or cell depletion therapy within 3 months before the first administration of the study drug or within 5 half - lives (whichever is longer).
✕. Received JAK inhibitors and/or S1P agonists within 5 half - lives or within 2 weeks (whichever is longer).