9 results
PHASE IIPrimary ObjectiveThe primary objective of the Phase II portion of the study is to estimate the efficacy as measured by radiographic progression-free survival of IPATASERTIB (GDC-0068) (dosed at either 400 mg or 200 mg daily) + abiraterone…
The purpose of this trial is primarily to assess the efficacy of inhaled mannitol compared with a true placebo in subjects with cystic fibrosis aged 6 to 17 years.We hypothesize that inhaled mannitol will improve the overall health and hygiene of…
Primary:* To assess the sustained efficacy of tofacitinib versus placebo in sJIA patients, as measured by time to sJIA flare in the double-blind randomized withdrawal phase.Secondary:* To assess efficacy of tofacitinib versus placebo in sJIA…
Primary objective: • To evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC.Secondary objectives:• To evaluate the overall efficacy of tofacitinib during induction, maintenance and…
To assess efficacy and safety of tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis.
Primary* The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.Secondary* The secondary objective of this study is to evaluate the persistence of…
Primary objective:Identify pre-treatment profiles with integrated clinical, transcriptomic, metabolomic, proteomic, flow cytometric, and imaging data that predict response to treatment with tofacitinib, in DMARD-naïve and DMARD non-responsive PsA…
To evaluate the tofacitinib and infliximab treatment-induced changes in plasma lipids and lipoproteins and to provide insight in the underlying mechanism in relation to the inflammatory status in patients with active UC.
The objectives of this study, in patients with moderately to severely active UC who are administered JAKi SOC therapy are to evaluate the following (ranked according to priority), both for JAKi as a class of drugs and for each individual JAKi:1.…