8 results
Primary: To determine whether or not consistent exposures can be achieved in neonates and preterm infants with presumed GERD receiving oral doses of pantoprazole. Secondary: PK and PD assessment after single dose and steady state. Determination fo…
Primary Objective• To evaluate the efficacy of apremilast 30 mg BID * NSAIDs and/or csDMARDs vs. Placebo * NSAIDs and/or csDMARDs in subjects with early oligoarticular PsA, assessed by modified MDA (MDA-Joints).Secondary Objectives · To evaluate the…
Primary Objective: To evaluate the achievement of partial remission by apremilast combined with doxycyclineat week sixteen (t=16). Secondary Objectives: • Complete remission at week sixteen; • Disease control at week six (t=6); • Drug survival;•…
Primary objectives: To evaluate the expression of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16): - of subjects receiving apremilast compared to subjects receiving placebo;- within both groups relative to…
2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…
The main objective of study 20190530 is to estimate the efficacy of Apremilast compared to placebo in the treatment of oral ulcers in pediatric subjects from 2 to < 18 years of age with oral ulcers associated with BD through week 12. See…
Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis (JPsA) in pediatric subjects 5 to less than 18 years of age.Refer to section 3 of the protocol for more information.
Primary ObjectiveThe primary objective of the study is to evaluate the clinical efficacy of apremilastcompared with placebo in children and adolescents (ages 6 through 17 years) withmoderate to severe plaque psoriasis.Secondary Objectives- * To…