8 results
Primary: assess the effect of tralokinumab compared with placebo in patients with active ulcerative colitis by assessment of clinical response, as defined by the Mayo score, at week 8.Other objectives: assess the change in (partial) Mayo scores…
Primary• To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin• To assess the pharmacokinetics of brentuximab vedotin• To determine the overall response rate (complete…
Primary objective:• To evaluate the effect of tralokinumab compared to placebo in reducing the prescribed, OCS maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance OCS in addition to ICS/LABA.…
Our hypothesis is that treatment of peri-anal fistula with laser ablation is associated with equal closure rates compared to current therapies. As secundairy outcome, quality of life, postoperative pain and incontinence will be assessed. The primary…
Lead in phase 1Primary objective:• To identify the feasibility and RDL (recommended dose level) of brentuximab vedotin in combination with R-DHAPSecondary objective:• To assess the toxicity of brentuximab vedotin in combination with R-DHAP• To…
• Determine a feasible 89Zr-brentuximab-PET imaging schedule, to allow assessment of the biodistribution of 89Zr-brentuximab in tumor and non-target lesions or -organs.• Establish safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of…
primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP, each followed by radiotherapy on PET-positive residual lesions, in terms of progression free survival (…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…