25 results
The primary objective of this study is to evaluate whether adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation reduces…
To investigate the efficacy and safety of BIBF 1120 as compared to placebo in patients with stage IIIB/IV or recurrent non small cell lung cancer treated with standard therapy of pemetrexed after failure of first line chemotherapy.
The aim of this study is to assess the effect of AZD1981 on histology (lung tissue biopsy) and inflammatory cells (broncho alveolar lavage [BAL] and induced sputum), symptoms, lung function, exercise tolerance and on inflammatory mediators in sputum…
Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…
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…
Primary: The primary objective of this study is to assess relative to placebo, the efficacyof teplizumab when administered according to 3 different teplizumab dosing regimens in subjects with recent-onset T1DM (within 12 weeks of presentation of…
The primary objective of the study is to evaluate the efficacy of intralesional administration of eASCs (CX-401) when added to standard surgical care and drainage for the treatment of complex perianal fistulas in patients with Crohn*s disease (CD).
The study will be performed in 2 parts, Parts 1 and 2. The volunteers can only participate in one of the two parts of this study. The purpose of Part 1 of the study is to investigate to what extent RO6806127 is tolerated. It will also be…
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 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…
To show in a prospective randomised study if intravitreal injection of Triamcinolonacetonide combined with Macula Grid Laser gives a better increase in visual acuity and/or decrease in macular edema than Macula Grid Laser combined with sub-Tenon…
Primary* To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms * To compare overall survival (OS) between treatment…
The primary objective of the study is:To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levelsThe Secondary objectives are:To evaluate effect of two doses of ESN364 versus…
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.
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 objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…
Primary ObjectiveTo determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of…
Primary Objective:• To evaluate event-free survival (EFS) after blinatumomab when compared to standard ofcare (SOC) chemotherapySecondary Objective(s):• To evaluate the effect of blinatumomab on overall survival (OS) when compared to SOCchemotherapy…
This Phase 2 study for JNJ-63733657 will assess the possible slowing of cognitive decline seen inprodromal AD and mild AD dementia (Early AD). In addition, effects of JNJ-63733657 on theaccumulation of tau, as measured by tau positron emission…
The primary objective of this study is to assess the efficacy, measured by OS, of capivasertib + docetaxel versus placebo + docetaxel, with both groups receiving continuous ADT. The primary endpoint is OS in patients who have mCRPC and have received…