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NCT ID: NCT05490563 Terminated - Clinical trials for Spinocerebellar Ataxia Type 3

STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia

STRIDES
Start date: June 3, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Phase 2b/3 double blind, randomized, placebo-controlled trial to assess safety and efficacy of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of adults with spinocerebellar ataxia).

NCT ID: NCT05479058 Terminated - Ulcerative Colitis Clinical Trials

A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

CAPYBARA
Start date: July 26, 2022
Phase: Phase 3
Study type: Interventional

Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d.

NCT ID: NCT05447663 Terminated - Clinical trials for Acute Myeloid Leukemia

A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant

Start date: February 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to confirm a safe dose and schedule as well as the preliminary efficacy of siremadlin alone, and in combination with donor lymphocyte infusion (DLI), in adult participants with AML who are in remission following allogeneic stem cell transplantation (allo-SCT) but are at high risk for relapse based on the presence of pre-transplant risk factors.

NCT ID: NCT05445258 Terminated - Clinical trials for Lesions in the Superficial Femoral Artery and/or Popliteal Artery Pars I/II

Safety and Tolerance of the Use of InnoCath AB® Hyper-compliant Balloon

HYPER
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

This is a 'first in man' study to demonstrate compliance with the general safety and performance requirements of Regulation (EU) 2017/745 on medical devices (MDR) Annex I as part of the clinical evaluation and for the application of CE-marking. The aim of the study is to evaluate the safety and tolerability of the application and the success rate of the InnoCath AB® hyper-compliant balloon catheter after PTA in peripheral arteries.

NCT ID: NCT05439941 Terminated - Atopic Dermatitis Clinical Trials

A Long-Term Extension Trial in Participants With Atopic Dermatitis Who Participated in Previous EDP1815 Trials

Start date: June 6, 2022
Phase: Phase 2
Study type: Interventional

This is an Open-Label Extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of EDP1815 in participants with mild, moderate, and severe atopic dermatitis who have completed the treatment period of a prior clinical study ("parent study") with EDP1815. The current parent study of this protocol is the EDP1815-207 study; A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Cohort Study Investigating the Effect of EDP1815 in Participants for the Treatment of Mild, Moderate and Severe Atopic Dermatitis.

NCT ID: NCT05430555 Terminated - Clinical trials for Advanced Solid Tumors

A Phase 1/ 2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/ Metastatic MAGE-A1+ Solid Tumors

IMAG1NE
Start date: July 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to determine the safety, tolerability and anti-tumoral activity of autologous T cells transduced with a T cell receptor specific for MAGE-A1 in eligible patients with advanced solid tumors.

NCT ID: NCT05418673 Terminated - Parkinson Disease Clinical Trials

A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale

LIGHTHOUSE
Start date: August 26, 2022
Phase: Phase 3
Study type: Interventional

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic variant in their LRRK2 gene. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of PD more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. - The MDS-UPDRS measures impairment and disability in people living with PD. It was created in the 1980s and is one of the most used rating scales for PD symptoms. - The MDS-UPDRS has 4 parts, and a higher score means more severe PD symptoms. - Part I assesses non-motor experiences of daily living, including but not limited to memory loss, problems sleeping, pain, depression, and anxiety. - Part II measures motor experiences of daily living. - Part III is the results of a motor symptoms exam by a medical professional. - Part IV records PD complications caused by motor symptoms. Researchers will also learn more about the safety of BIIB122. A description of how the study will be done is given below. - Participants will take BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but contains no real medicine. - Participants will be in the study for 103 weeks to 187 weeks. This includes the screening and follow-up periods. - Participants will take BIIB122 or placebo 1 time a day for 96 to 180 weeks. - Participants can continue to take certain medications for PD. Participants must be on the same dose of medication for at least 90 days before the study begins. - Participants will visit the clinic less often as the study continues, ranging every 4 weeks to every 24 weeks.

NCT ID: NCT05418101 Terminated - Autoimmune Diseases Clinical Trials

A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)

Start date: April 28, 2022
Phase: Phase 1
Study type: Interventional

This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).

NCT ID: NCT05396755 Terminated - Clinical trials for Secondary Sclerosing Cholangitis

Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis (BISCIT)

BISCIT
Start date: November 14, 2022
Phase: N/A
Study type: Interventional

This is a randomized, open-label, controlled, parallel group, multicenter clinical trial. Patients with confirmed secondary sclerosing cholangitis (SSC-CIP) will be randomized either in the intervention group undergoing scheduled invasive evaluation of the biliary tract or in the control group treated with non-interventional standard of care to demonstrate that programmed endoscopic therapy compared to a conservative strategy reduces the occurrence of treatment failures.

NCT ID: NCT05367843 Terminated - Clinical trials for SARS-CoV-2 Infection

A Study Assessing the Safety, Tolerability, Immunogenicity of COVID-19 Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV_2 Spike and Nucleocapsid Proteins

Start date: June 20, 2022
Phase: Phase 1
Study type: Interventional

PRIME-2-CoV_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of SARS-CoV-2. The aim of the multivalent vaccine is to broaden the specific immune response against SARS-CoV-2 and to increase the probability of cross-protection against emerging variants.