A 12-week, phase II, multicentre, randomised, double blind, efficacy and safety study comparing CPL409116 to placebo, in combination with methotrexate in participants with active rheumatoid arthritis who have an inadequate response to methotrexate
Dear Sir or Madam,
Rheumatoid arthritis (RA) is a chronic autoimmune connective tissue disease that primarily affects joints and is associated with progressive disability and premature death. RA characterized by persistent joint inflammation leading to loss of joint function as well as cartilage and bone damage.
The triggers of disease remain not fully recognized but may include smoking, silica exposure, infectious agents, vitamin D deficiency, obesity and changes in the microbiota. In most patients, the pathogenetic process begins years before clinical onset of RA, although acute onset is also possible.
Celon Pharma’s product PG24, with CPL409116 as an active ingredient is designed predominantly in therapy of immune-related diseases as rheumatoid arthritis, psoriasis.
The CPL409116 has a dual mechanism of action related to JAK inhibition and Rho-associated kinases inhibition that can be extremely supportive in patients with RA in whom the risk of cardiovascular events is significantly increased.
The main clinical trial purpose is to determine the efficacy of CPL409116 at 12 weeks, in subjects with active RA who have had an inadequate response to methotrexate (MTX).
We would like to invite you to participate in the study named „A 12-week, phase II, multicentre, randomised, double blind, efficacy and safety study comparing CPL409116 to placebo, in combination with methotrexate in participants with active rheumatoid arthritis who have an inadequate response to methotrexate"
Clinical trial results will be used to further development of new drug