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NCT ID: NCT04737330 Terminated - Thyroid Eye Disease Clinical Trials

A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)

ORBIT
Start date: November 29, 2021
Phase: Phase 3
Study type: Interventional

Thyroid eye disease (TED) is a rare autoimmune, inflammatory disorder of the orbit and represents the most common extra-thyroidal manifestation of Graves' disease (GD). Several lines of evidence suggest an important role of interleukin-17A (IL-17A) in the pathogenesis of TED; increased levels of IL-17A have been detected in the serum and tears of patients with TED and IL-17A levels correlate with clinical activity of the disease. Th17 cells (as well as other cellular sources of IL-17A, e.g. Tc17 cells)have been shown to infiltrate the orbital tissue of affected patients, producing IL-17A. IL-17A stimulates fibroblast activation, leading to retrobulbar tissue expansion and orbital fibrosis, which causes significant functional impairment. Secukinumab is a recombinant high-affinity fully human monoclonal anti-IL-17A antibody currently approved for the treatment of 3 inflammatory/ autoimmune diseases: moderate to severe plaque psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) (ankylosing spondylitis (AS) and non-radiographic axSpA). The purpose of this study was to demonstrate the efficacy and safety of secukinumab 300 mg s.c. in adults with active, moderate to severe TED.

NCT ID: NCT04736745 Terminated - Clinical trials for Severe Upper Facial Lines

Study to Evaluate the Safety and Efficacy of IPN59011 in Improving the Appearance of Moderate to Severe Upper Facial Lines.

LONG-SET
Start date: February 10, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the protocol, is to assess the safety and efficacy profile of IPN59011 compared to a placebo. IPN59011 is expected to work longer than product already marketed in the treatment of subjects with moderate to severe facial wrinkles.

NCT ID: NCT04734873 Terminated - Covid-19 Clinical Trials

CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.

NCT ID: NCT04730349 Terminated - Neuroblastoma Clinical Trials

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer

PIVOT IO 020
Start date: June 3, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.

NCT ID: NCT04727541 Terminated - Cholangiocarcinoma Clinical Trials

Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer

NEOBIL
Start date: July 8, 2021
Phase: Phase 2
Study type: Interventional

The NEOBIL study aims to investigate the feasibility, safety and efficacy of neoadjuvant Bintrafusp alfa in patients with resectable biliary tract cancer.

NCT ID: NCT04722666 Terminated - Clinical trials for Major Depressive Disorder With Suicidal Ideation With Intent

Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent

Start date: July 20, 2021
Phase: Phase 2
Study type: Interventional

Study of efficacy and safety of MIJ821 in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder (MDD) in subjects who have suicidal ideation with intent

NCT ID: NCT04711850 Terminated - Clinical trials for Kidney Transplant Rejection

An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR

Start date: January 21, 2021
Phase:
Study type: Observational

The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients. This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12, in which patients received either imlifidase or plasma exchange (PE) as AMR treatment. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) are collected.

NCT ID: NCT04705051 Terminated - Clinical trials for Congenital Cystic Kidney Disease

Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat

STAGED-PKD-EXT
Start date: February 9, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD). Secondary Objective: - To determine the effect of early versus delayed treatment with venglustat on the renal function (estimated glomerular filtration rate [eGFR] [Chronic Kidney Disease Epidemiology Collaboration {CKD-EPI} equation]). - To characterize the safety profile of venglustat. - To evaluate the effect of venglustat on the lens by ophthalmological examination. - To evaluate the effect of venglustat on mood using Beck Depression Inventory-II (BDI-II).

NCT ID: NCT04703413 Terminated - Clinical trials for Bladder Voiding Dysfunction

User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.

Start date: December 17, 2020
Phase: N/A
Study type: Interventional

An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.

NCT ID: NCT04700280 Terminated - Clinical trials for Primary Sjögren Syndrome

A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS)

GLIDER
Start date: January 28, 2021
Phase: Phase 2
Study type: Interventional

This is a first exploration of GLPG3970 in participants with active primary Sjogren's Syndrome (pSS) to evaluate the efficacy, safety and tolerability and to determine its pharmacokinetics (PK) profile compared to placebo.