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Sulodexide for chronic heart failure: a proof of concept, randomized, open-label, placebo-controlled study

To assess the efficacy of treatment with sulodexide for chronic heart failure.

A phase II, open label study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with advanced unresectable/metastatic Merkel Cell Carcinoma progressing on anti-PD(L)1 antibody therapy - the MERKLIN 2 study

Objectives:Primary Objective: to investigate the anti-tumor efficacy of domatinostat in combination with avelumab in advanced unresectable/metastatic MCC patients progressing on anti-PD-(L)1 antibody monotherapy.Secondary Objectives: to investigate…

Neo-adjuvant T-VEC + Nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease.

Primary objective:- To investigate if neo-adjuvant combination of talimogene laherparepvec and nivolumab will achieve a pathologic response rate of 45% complete responses (either *pathological complete response (pCR)* or *pathological near complete…

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis

To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…

A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination with Durvalumab and in Combination with Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC).

ObjectivesPrimary* To determine the efficacy (as assessed by radiographic progression free survival [rPFS]) of AZD4635 plus durvalumab and separately of AZD4635 plus durvalumab plus cabazitaxel in participants with mCRPC.Secondary* To evaluate the…

Dupilumab in adults with severe chronic hand eczema with an inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled proof of concept efficacy study

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:…

Short-term combined acalabrutinib and venetoclax treatment of newly diagnosed patients with CLL at high risk of infection and/or early treatment, who do not fulfil IWCLL treatment criteria for treatment. A randomized study with extensive immune phenotyping.

This study has been transitioned to CTIS with ID 2024-511072-33-00 check the CTIS register for the current data. The aim is thereby to reduce the risk of serious infections and the need for regular CLL treatment.

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to
Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with
Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or
Branebrutinib Treatment Followed by Open-label Abatacept Treatment in
Subjects with Active Rheumatoid Arthritis.

pSS: • To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with pSS• To compare the safety and tolerability of branebrutinib with PBO in subjects with pSSRA: • To compare the efficacy of branebrutinib with PBO…

Neo-adjuvant nivolumab or nivolumab with ipilimumab in advanced cutaneous squamous cell carcinoma patients prior to standard of care surgery; the MATISSE trial

Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…

A PHASE I/II, MULTICENTER, OPEN-LABEL, MULTI-ARM STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF IDASANUTLIN IN COMBINATION WITH EITHER CHEMOTHERAPY OR VENETOCLAX IN THE TREATMENT OF PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LEUKEMIAS OR SOLID TUMORS.

This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…

B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping

Primary objective:To assess the effect of 12 weeks of GSK3228836 on serum hepatitis B virus surface antigen (HBsAg) levels in participants with CHBSecondaryEfficacy: To assess sustainability of serum HBsAg loss by GSK3228836 for up to 24 weeks off-…

Tiratricol treatment of children with Monocarboxylate Transporter 8 deficiency: Triac Trial II

This study has been transitioned to CTIS with ID 2024-516123-13-00 check the CTIS register for the current data. Part I:Primary Objective: Evaluate the effects of tiratricol on neurodevelopment in young MCT8 deficiency patients, as measured by the…

A PHASE 2 STUDY OF FUTIBATINIB IN PATIENTS WITH SPECIFIC FGFR ABERRATIONS

Cohorts A nd B :The primary objective is to evaluate the objective response rate (ORR) in patients with solid tumors harboring FGFRrearrangements or gastric cancer (including GEJ cancer) harboring FGFR2 amplifications based on independent central…

Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.

This study has been transitioned to CTIS with ID 2023-509881-39-00 check the CTIS register for the current data. The aim of this study is to evaluate the difference in the fraction of patients that have disease progression within 6 months after…

A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis

To evaluate the efficacy based on the histological response

A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy

Primary objectives:To determine the safety and tolerability of CK-3773274 in patients with symptomatic HCMSecondary objectives:- To describe the concentration-response relationship of CK-3773274 on the resting and post-Valsalva LVOT-G on…

An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475
(Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin
Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE
667).

This study has been transitioned to CTIS with ID 2023-504821-38-00 check the CTIS register for the current data. Goal of this study is to determine the optimal balance between maintaining high rates of OS in this group and avoiding the long-term…

EXPLORE: a phase 2, outcomes assessor-masked, multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration

The overall objectives of the study are to evaluate the safety and efficacy (anatomical and functional visual outcomes) of two doses of GT005 in genetically defined subjects with GA due to AMD.

A phase III Prospective Externally Controlled Non-Inferiority Cohort Trial to Compare the Efficacy of Re-Irradiation Schedules in Glioma (RISinG)

To determine if re-irradiation in 4 fractions is non-inferior to 10 fractions in the primary endpoint of survival after re-irradiation. Secondary objectives are to establish and compare health related quality of life (HRQoL), recurrence patterns,…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia

This study has been transitioned to CTIS with ID 2023-503771-13-00 check the CTIS register for the current data. The purpose of this study is to see if tildacerfont can reduce the amount of GC (e.g., hydrocortisone) you need to take and reduce the…