22 results
To evaluate the effects of intravenous iron suppletion in iron deficient PAH patients.Amendment: to compare exercise capacity and isolated muscle strength in IPAH patients and healthy controls
Secondary objectives are to evaluate the effect of intravenous FCM compared to pla¬cebo on:1. Evolution from baseline of cardiac function parameters as assessed by 2D Echo/Doppler cardiography 4, 12 and 24 weeks after start of study treatment.2.…
To examine if intravenous administration of iron ismore efficacious than oral iron in improvement offitness scores, iron status and reduction of fatigue
Primary:Evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma study.Secondary:Evaluate the efficacy of dupilumab in patients with asthma who participated in a previous…
Primary objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.Secondary objectives:To evaluate the safety and…
To evaluate the efficacy of dupilumab compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in patients with bilateral nasal…
Primary Objective(s)* To evaluate, relative to placebo, the effect of intravenous (IV) FCM on repeated heart failure (HF) hospitalisations and cardiovascular (CV) death.Secondary Objective(s)* To evaluate, relative to placebo, the effect of IV FCM…
Main study:To evaluate the efficacy of dupilumab in patients with inflammatory subtypes of severe chronic hand eczema with an inadequate response or intolerance to alitretinoin and in patients with concomitant positive patch test results.Substudy:…
To assess the effect of dupilumab on sleep, to evaluate the effect of dupilumab on additional patient reported sleep outcomes, on objective sleep assessment, asthma symptoms, long function and the safety of dupilumab.
The primary efficacy objective of this trial is to evaluate the anti-tumor activity of pembrolizumab in subjects with any of a *basket* of rare malignancies (biomarker unselected and biomarker selected). ORR will be used as the primary endpoint per…
Based on the success of the pilot feasibility study, we propose a follow-up efficacy study to explore neo-adjuvant ICB therapy as potential alternative for SoC adjuvant radio(chemo)therapy in MMRd UC.
Primary:To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-5890 when used as monotherapy and in combination with pembrolizumab in the dose escalation and confirmation phase and the dose…
Main objective:English To determine the antitumor activity of SAR444245 in combination with other anticancer therapiesSecondary objectives: English - To assess the safety of SAR444245 when combined with other anticancer therapies- To assess other…
This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.
Primary:To compare the efficacy of abrocitinib 200 mg once daily (QD) versus dupilumab (as per label guidelines) in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD).Key SecondaryTo compare the efficacy…
We aim to establish proof-of-concept for use of pembrolizumab as novel neo-adjuvant therapy in dMMR and POLE-EDM UC. When ICB proves to be feasible as defined in the primary endpoint (see 2.1), we will follow-up with larger studies to determine…
To study the effects of FCM on exercise tolerance, haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, microbiota, the immune system, the incidence of infections, allograft failure and mortality in…
- The purpose of this study is to evaluate the efficacy of the study drug to lung function, exacerbations and quality of life with patients with COPD. The safety and tolerability of the study drug is monitored as part of this study.
To evaluate if hepcidin levels can predict response to iron therapy with either ferrous fumarate, ferric maltol, and intravenous iron in patients with IBD.
The primary objective of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progressionfree survival (PFS) (by independent imaging…