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International multicenter, open-label, phase 2 study to treat molecular relapse of pediatric acute myeloid leukemia with azacitidine

• Primary Objective: To evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after CR1 with regard to molecular response prior to further treatment (reinduction / HSCT)• Secondary Objectives:o To assess safety of…

A Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of T 817MA in patients with mild cognitive impairment due to Alzheimer*s Disease or mild Alzheimer*s Disease.

To evaluate the efficacy and safety of T-817MA in patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease.

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

This study has been transitioned to CTIS with ID 2023-504736-18-00 check the CTIS register for the current data. Primary Objectives (Phase 2 and Phase 3):- To evaluate the clinical efficacy of guselkumab in participants with Crohn*s disease- To…

A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)

Primary Efficacy Objective:Primary objective: To evaluate if the addition of ISA101b to cemiplimab results in improved overall response rate (ORR) compared to cemiplimab alone, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1…

An explorative study for halting inflammation in patients with emphysema by administration of allogeneic bone marrow derived mesenchymal stromal cells.

Development of mesenchymal stromal cell therapy to halt the progression of emphysema.

Neoadjuvant AXITINIB plus AVELUMAB for patients with localized RCC and a moderate to high risk of recurrence

This study has been transitioned to CTIS with ID 2024-515825-27-00 check the CTIS register for the current data. To investigate efficacy of neoadjuvant axitinib and avelumab in patients with localized renal cell carcinoma with moderate to high risk…

An open-label, multi-center, roll-over study to assess long term safety of lenvatinib monotherapy or lenvatinib combination regimen or comparator treatment arm to cancer patients in Eisai sponsored lenvatinib trials

The primary objective is to assess long-term safety of study drug(s) in subjects who are enrolled in Eisai-sponsored lenvatinib studies.

A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumors

Primary Objective:* To evaluate ORR of avelumab in combination with talazoparib, in patients with locally advanced or metastatic solid tumors harboring BRCA1, BRCA2 or ATM defect.Secondary Objective:* To assess the overall safety and tolerability of…

First in-human study on the Safety, Tolerability and Efficacy of the Aqua Medical focal vapor ablation system, for the eradication of Barrett*s Esophagus

The aim of the current study is to assess the feasibility, safety and efficacy of the Steam ablation System for eradication of small BE areas

A multi-centre, randomized, double-blind (sponsor open), placebocontrolled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis (study 201247)

Primary:To evaluate the safety and tolerability of repeat subcutaneous doses of GSK2330811 in participants with dcSSc.Secondary:PK. PD (serum levels of total and free OSM). Antibodies against GSK2330811.

An open-label study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of risdiplam (RO7034067) in adult and pediatric patients with spinal muscular atrophy

This study has been transitioned to CTIS with ID 2023-506739-14-00 check the CTIS register for the current data. Primary ObjectivesThe primary objectives of this study are as follows:• To evaluate the safety and tolerability of risdiplam.• To…

PERICLES (PEnile cancer Radio- and Immunotherapy CLinical Exploration Study) - a Phase 2 study of atezolizumab with or without radiotherapy in penile cancer

The primary objective is efficacy of atezolizumab in advanced penile cancer patients measured by progression-free survival.

A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (Dose Escalation of CPI-0610 in Patients with Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 with and without Ruxolitinib in Patients with Myeloproliferative Neoplasms)

Phase 2 (MF Expansion-Prior JAKi Arm 1 and Add-on to JAKi Arm 2) Primary Objectives:- To evaluate splenic response rate by imaging after 24 weeks of treatment in Cohorts 1B and 2B (i.e., in non-TD cohorts)- To evaluate the rate of conversion from…

A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination with Ipilimumab or Nivolumab Monotherapy in Participants with Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Primary Objectives:• To compare Blinded Independent Committee for Radiology (BICR)-assessed objective response rate (ORR) in participants of tissue Tumor Mutational Burden-High (tTMB-H) treated with nivolumab combined with ipilimumab • To compare…

iPAVE - imaging Pituitary ActiVation by Exendin

The study objective is to compare the pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss or classification by the treating diabetologist) to GLP-1R agonist treatment, to increase…

A PHASE 2, SINGLE-ARM, MULTI-COHORT, MULTI-CENTER TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH AGGRESSIVE B-CELL NON-HODGKIN LYMPHOMA

Primary ObjectivesCohorts 1, 2, 3, 4, and 5• Determine the efficacy, defined as overall response rate (ORR), of JCAR017 in subjects with aggressive B-cell non-Hodgkin lymphomaCohort 7• Evaluate the safety of JCAR017 treatment in subjects intended to…

A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis with Symptoms Inadequately Controlled with Standard Therapy

This study has been transitioned to CTIS with ID 2024-512585-34-00 check the CTIS register for the current data. Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To…

A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFNγ) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still*s Disease (AOSD) developing Macrophage Activation Syndrome/ secondary HLH (MAS/sHLH)

The aim of this study is to investigate how safe, effective, and well-tolerated multiple infusions of the experimental study treatment, emapalumab (the study medication) are in controlling this disease, as well as to check the concentrations of…

A randomized, subject and investigator blinded, placebo-controlled, multicenter study in parallel groups to assess the efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne

Primary objectiveTo assess the efficacy of LYS006 versus placebo on facial inflammatory lesion counts in patients with moderate to severe inflammatory acneSecondary objectiveTo assess the safety and tolerability of LYS006 in patients with moderate…

Transfer of feces in ulcerative colitis 2; improving efficacy

To study the efficacy and safety of FMT augmented by donor selection and repetitive dual route administration.To study microbiota composition, functional and metabolic changes as a result of dietary modulation and FMT.