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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

* The primary objective of this study is to compare the proportion of warm antibody autoimmune hemolytic anemia (wAIHA) subjects whoachieve a durable hemoglobin response between the fostamatinib and placebo groups.* The secondary objectives of this…

Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn*s Disease that failed conventional treatment

The aim of this preliminary study is to prospectively assess the efficacy of LDN as induction therapy in CD.

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Primary objective (Parts A and B):To evaluate the long-term safety and tolerability of VX-445/TEZ/IVA in subjects with CF who are heterozygous for the F508del mutation and a gating (F/G) or residual function (F/RF) mutation.Secondary objectives (…

Deciphering the functional dynamics of the immune system during (immune)therapy in children with neuroblastoma

We aim to identify immunological parameters during (immune)therapy. We will study the effect of (immune)therapy on generic immune mediators and more specifically for NK cell, T effector and Treg cell functionality. Furthermore, we will explore DNX…

A Phase II, two arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study)

The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…

The effect of different radiotherapy regimen on the immune cell landscape

We want to investigate what happens to the immune cells during different types of radiotherapy (schedules). With this study, we want to take blood samples from patients during their standard radiotherapy for cancer and determine the effect on immune…

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

This study has been transitioned to CTIS with ID 2024-513513-12-00 check the CTIS register for the current data. Primary ObjectivesEvaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants…

Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients with Fabry Disease

To evaluate the ongoing safety, tolerability, and efficacy parameters of pegunigalsidase alfa in adult Fabry patients who have successfully completed studies PB-102-F20 and PB-102-F30, or completed at least 48 months in study PB-102-F03.

A 12 month, open label, parallel-cohort study to evaluate the efficacy, safety and tolerability of canakinumab in children with Kawasaki disease

The objective of this study is:1. To evaluate the efficacy, safety and the tolerance of Canakinumab in 'IVIG-resistent' patients (cohort 1) and 'IVIG-naive' patients (cohort 2) with Kawasaki disease.2. To evaluate the incidence…

Randomized Autologous heMatopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis

This study has been transitioned to CTIS with ID 2024-510630-40-00 check the CTIS register for the current data. The objective of this prospective, randomized study is to investigate the efficacy and safety of HSCT compared to the comparator group (…

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

To evaluate the effect of tezepelumab as compared with placebo on COPD exacerbations in subjects with moderate to very severe COPD

Cannabis-opioid interaction in the treatment of fibromyalgia pain - an open label proof of concept study with randomization between treatment groups: cannabis, oxycodone or cannabis/oxycodon combination.;substudy: follow-up vragenlijst

The main objective is to assess whether Bediol (containing THC and CBD) co-treatment will reduce opioid side effects in chronic pain patients. A secondary objective will be that Bediol is superior to oxycodone in the relief of chronic fibromyalgia…

Longstanding Exercise Therapy in Patients with axial Spondyloarthritis

This study aims to underpin the delivery of longstanding exercise therapy in the subgroup of patients with axSpA and complex disability.There are 2 research questions to be addressed 1. Is longstanding, optimized active exercise therapy more…

A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF HE3-DXd IN SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER

This study has been transitioned to CTIS with ID 2024-511205-33-00 check the CTIS register for the current data. Dose Expansion:Primary Objective-*To investigate the antitumor activity of HE3-DXdSecondary Objectives-*To assess the safety and…

Tofacitinib: salvage therapy for patients with RCDII - a pilot study

To evaluate the efficacy of tofacitinib treatment in patients with RCDII with persistent or recurrent villous atrophy (Marsh III ABC) and aberrant IEL T-cells (> 20% as assessed by flow cytometry).

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens

Primary Objective:• To assess and compare efficacy of sacituzumab govitecan to TPC as measured by progression free survival (PFS) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1…

Functional Improvement of non-infarcT relaTed coronary artery stenosis by Extensive LDL-C Reduction with a PCSK9 Antibody.

Primary objectives1A. To evaluate the effect of maximal LDL-C reduction by Evolocumab on top of high intensity lipid-lowering therapy , initiated immediately after invasive ACS treatment on functional impairment of non-infarct related artery (non-…

A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment

Primary: To assess the efficacy of GNX compared with PBO, as adjunctive therapy for the treatment of primary seizure types in children with genetically-confirmed PCDH19-related epilepsy during the 17-week double-blind (DB) phase. Secondary: • To…

A Phase 1 first- in-human dose escalation and expansion study for the evaluation of safety,
pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR441000 administered intratumorally as monotherapy and in combination with cemiplimab in patients with advanced solid tumors

Primary Objectives: Dose Escalation (SAR441000 Monotherapy): -To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the overall safety and tolerability profile of SAR441000 when administered intratumorally as…

Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis

To explore the effect of treatment with guselkumab in subjects with Familial Adenomatous Polyposis (FAP) on rectal/pouch polyp burden (the sum of the polyp diameters)