116 results
Primary ObjectivePhase Ia* To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)and assess the safety of single agent GDC-0810 in postmenopausal women with locally advanced or metastatic estrogen-receptor-positive (ER…
The primary objectives of this study are:1. To evaluate the safety and tolerability of PTG-1002. To evaluate the efficacy of PTG-100 in the induction treatment of subjects with moderate to severe active UC compared to placebo.The secondary…
The primary objective of the study is Study to determine the Safety, Tolerability, Pharmacokinetics and Effect on Circulating Alpha-1 Antitrypsin Levels of ARC-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD)
The primary objective of the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…
Primary objectiveTo determine whether the clinical response after 10-day oral administration of cadazolid is non-inferior to oral vancomycin in subjects with CDAD.Secondary objectivesTo determine whether oral administration of cadazolid for 10 days…
The primary objective of this confirmatory study is to confirm the acid neutralisation action of Gaviscon Double Action Liquid versus placebo liquid, within the stomach.
Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy.Timepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To evaluate the activity of FL-101…
Primary Objective:To evaluate the efficacy of LN-145 measured by objective response rate (ORR) usingResponse Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by theIndependent Review Committee (IRC) for Cohorts 1 and 2 and by the…
To assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic AD with demonstrated presence of low-medium tau pathology.
Objectives: Primary:• To evaluate the long-term safety and tolerability of AG-348Secondary:• To evaluate the long-term efficacy of AG-348• To evaluate the efficacy of AG-348 in increasing hemoglobin (Hb) concentrations in subjects who previously…
PrimaryCompare the efficacy (measured by objective response rate [ORR] and overall survival [OS]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.SecondaryAssess other measures of clinical benefit, safety,…
Primary* To compare TFFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with LOXO-292 versus cabozantinib or vandetanib.Secondary* To compare other efficacy outcomes, based on RECIST 1.1 criteria, observed in…
Primary: To evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:* To evaluate the…
Efficacy of ALXN1210Sub-study: to Evaluate Patient Preference for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
Primary: To evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:*…
The objective of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.
Primary (Efficacy):To evaluate the efficacy of magrolimab + azacitidine compared with that of azacitidine + placebo in previously untreated participants with intermediate/high/very high risk MDS by IPSS-R as measured by CR rateTo evaluate the…
Core Primary Objectives:1. To investigate the safety and tolerability of EP0042 given alone or in combination with anti-cancer treatments.Module 1 Primary Objectives:1. To investigate the safety and tolerability of EP0042 given as a monotherapy in…
Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…