23 results
This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…
Primary: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebobased on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- mTTS structural damage week 24-…
Primary: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebo based on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- PASI75 week 24- PASI90 week 24-…
This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response.Secondary (key only): ASAS40 week 16 response in…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNF*…
The primary objective of this study is:• To evaluate whether selonsertib (SEL, previously known as GS 4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH. The secondary objective of this…
Primary Objectives•To assess and compare the efficacy of five doses of HM11260C (once weekly subcutaneous injections) over the 12 weeks from baseline in comparison with placebo (once weekly subcutaneous injections) on glycaemic control, as assessed…
The objectives of this exploratory trial are:1. To measure the pharmacodynamic (PD) effect on parameters derived from 24-hpH/impedance (MII) monitoring,2. To explore the effect on symptoms,3. To evaluate the safety and tolerabilityof treatment with…
This will be the first study with JNJ-63733657 in humans to investigate the safety, tolerability and pharmacokinetics of JNJ-63733657 and to explore potential pharmacodynamic (PD) effects in healthy subjects following single dose administration and…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response.Secondary (key only): ASAS responses in the…
This study is designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an…
Main Objective:To demonstrate the efficacy of secukinumab compared to placebo withrespect to HiSCR after 16 weeks of treatment.Secondary objective:To demonstrate the efficacy of secukinumab compared to placebo after 16 weeks of treatment with…
PrimaryTo determine the pharmacologically optimal dose of ALRN-6924 to induce transient cell cycle arrest in human bone marrow and other tissues.SecondaryTo characterize relative to ALRN-6924 administration the time to onset, the magnitude, and the…
Primary ObjectivesPart 1:To characterize the safety and tolerability of single ascending doses of PTC518 in healthy subjects.Part 2:To characterize the safety and tolerability of PTC518 administered for 14 or up to 21 days in healthy subjects.Part 3…
To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk NM-CRPC treated with apalutamide versus placeboSecondary Objective:To compare the overall survival (OS) of men with high risk NM-CRPC treated with apalutamide…
The purpose of this clinical research extension study is to evaluate whether prolonged treatment with secukinumab for up to another 4 years (Week 52 to Week 260) will bring benefits and be safe to patients with moderate to severe HS. The main…
To investigate the safety and tolerability of GSK2556286 after single ascending and repeat oral doses in healthy adult participants.To determine the pharmacokinetics of single and repeat oral doses of GSK2556286 in healthy participants.To assess the…
PrimaryTo evaluate the safety and tolerability of single and multiple doses of TBAJ-587 in healthy participants.SecondaryTo determine the pharmacokinetics (PK) of single and multiple doses of TBAJ-587 and metabolites M2, M3 and M12. To compare the…
The primary objectives for this study are:To evaluate the preventive effect of GYM329 on disuse muscle atrophy in healthy male volunteers through changes in muscle strength following a single subcutaneous administration prior to unilateral thigh and…