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*CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Hemorrhage: safety and proof-of-concept*

This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.

Assessing penetration of high dose Nicotinamide (Vitamin B3) in synovial fluid

NAM, well known as a dietary supplement, has also been extensively studied in humans in a variety of diseases in both children and adults. However, the bioavailability of NAM in patients with JIA at the side of inflammation, and therefore it*s…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects with Multiple Osteochondromas

Primary Objective• To evaluate the efficacy of two dosage regimens of palovarotene compared with placebo in preventing new osteochondromas (OCs) in subjects with multiple osteochondromas (MO) due to exostosin 1 (Ext1) or exostosin 2 (Ext2) mutations…

A Phase 1/2 study of the combination of pixantrone, etoposide, bendamustine and, in CD-20 positive tumors, rituximab in patients with relapsed aggressive non-Hodgkin lymphomas of B- or T-cell phenotype - The P[R]EBEN study

Primary Objectives- Determine the MTD of pixantrone, rituximab (only in CD20 positive tumors), etoposide, and bendamustine in *fit' patients with rel aNHL of B- or T-cell phenotype.- Evaluate the ORR and PFS using the combination of pixantrone…

PRACTICAL study: Pharmaco-enhancement in Rheumatoid Arthritis with Cobicistat to dose Tofacitinib In Clinic Adequately Low. A within-subject sequential study.

The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.

A single-arm, open-label, multicenter study of enfortumab vedotin (ASG-22CE) for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor (CPI) therapy.

Primary:* * To determine the antitumor activity of single-agent enfortumab vedotin as measured by confirmed objective response rate (ORR) in patients with locally advanced or metastatic urothelial cancer who have previously received systemic therapy…

Phase II, open-label, single arm, multicenter study of encorafenib, binimetinib plus cetuximab in subjects with previously untreated BRAF V600E -mutant Metastatic Colorectal Cancer

Primary:- To evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the confirmed overall response rate (cORR) by local radiologist/investigator assessment in adult subjects with previously…

An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471.

See protocol P5:The primary objective of this study is to evaluate the efficacy of 12 months of oral ACH-0144471 in participants with C3G or ICMPGNbased on histologic scoring and proteinuriaThe secondary objectives of this study are: * To evaluate…

A prospective, randomized, multicenter study of flecainide acetate oral inhalation solution in single and repeat dose regimens for acute conversion to sinus rhythm (SR) in subjects with recent onset of symptomatic paroxysmal atrial fibrillation (AF).

The objective of this study is to evaluate the safety, tolerability and efficacy of single and repeat doses of flecainide acetate oral inhalation solution in patients with paroxysmal AF.

A phase II, multicenter, randomized, two-arm study of capmatinib (INC280, an oral MET inhibitor) and spartalizumab (PDR001, a PD-1 inhibitor) combination therapy versus docetaxel in pretreated adult patient with EGFR wild-type, ALK rearrangement negative locally advanced/metastatic non-small cell lung cancer.

The aim of this prospective, multicentre randomized phase II study is to evaluate the safety and efficacy of the combination of capmatinib and spartalizumab in subjects with EGFR weight (for exon 19 deletions and exon 21 L858R substitution mutations…

A multi-centre, double blind, randomised, placebo-controlled, parallel group, phase II trial to determine the efficacy of intra-nodular injection of anti-TNF to control disease progression in early Dupuytren*s Disease

Primary objective: To determine if injection with the optimal dose of adalimumab (40mg) is superior to placebo injection of normal saline in controlling disease progression in patients with early Dupuytren*s disease.Secondary objectives: * To…

A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphoma

PrimaryPhase 1-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory cHL, DLBCL or PTCL, and to confirm the recommended Phase 2 dose (RP2D).Phase 2- Cohort A1 (anti-…

A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy

To assess efficacy of INCMGA00012 in terms of the ORR in participants with locally advanced or metastatic SCAC who have progressed after platinum-based chemotherapy.

An open-label single-arm Phase IIb study of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi in patients lacking suitable alternative treatment options.

Primary:• Describe the Data Review Committee (DRC)-adjudicated efficacy of F901318 as treatment for infections due to resistant fungi in patients lacking suitable alternative treatment options.Secondary:• Describe the safety of F901318 as treatment…

A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab plus Olaparib Combination Therapy Compared with Durvalumab Monotherapy as Maintenance Therapy in Patients whose Disease has not Progressed Following Standard of Care Platinum-Based Chemotherapy with Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)

Primary objective:-To assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS (Investigator-assessed)Secondary objectives:- To further assess the efficacy of durvalumab plus olaparib…

A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety,
Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib
Administered in Combination with Re-Induction Chemotherapy, and as a
Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML
Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years)
with FLT3-ITD mutations

This study has been transitioned to CTIS with ID 2023-510009-16-00 check the CTIS register for the current data. Primary Objectives:• Phase 1 Only: To determine the recommended Phase 2 dose(RP2D) of quizartinib, in combination with chemotherapy,…

The Effect of Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction on the Quality of Life: A Double-Blind Randomized Controlled Trial

The primary objective of this randomized controlled trial is to evaluate the effectiveness of sensory nerve coaptation in autologous breast reconstructions on the sensibility of the reconstructed breast, compared to spontaneous sensory recovery, and…

A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and
Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe
Hemolytic Disease of the Fetus and Newborn (HDFN)

Primary Objectives: - To evaluate the safety in mother and neonate/infant of nipocalimab administered to pregnant women at high risk for EOS-HDFN. - To evaluate the efficacy of nipocalimab as measured by proportion of patients with live birth at or…

Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

The primary objective of this study is to provide extended access to momelotinib (MMB) and assess long-term safety in 4 cohorts of subjects who are currently receiving treatment with MMB and have not experienced progression of disease:* Cohort 1:…

Autologous Dendritic Cells Loaded with Allogenic Tumor Lysate for Surgically Resected Pancreatic Cancer Patients (REACtiVe trial).

The aim of this research is to investigate whether it is feasible and safe to treat operated pancreatic cancer patients who have completed standard of care treatment with dendritic cell immunotherapy using dendritic cells loaded with autologous…