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Displaying 1 - 20 of 1002

SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

This is a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study is divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Kimberly Kelly

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Primary Objectives:

1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Tory Ham
Open Actively Recruiting

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Vladimir Kustanovich
Open Actively Recruiting

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Open Actively Recruiting

Investigating Safety, Tolerability, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours

A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.

Phase: Phase I
Primary Purpose: Treatment
Gender: All
Age Group: Adults, Children
Contact: Stacy Zamora
Open Actively Recruiting

The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients

To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery

Phase: Phase 4
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Julie Sorg
Open Actively Recruiting

Alzheimer's Disease Neuroimaging Initiative 4

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.

Phase: N/A
Gender: All
Age Group: Adults
Contact: Lorena Macias
Open Actively Recruiting

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month treatment period.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Children
Contact: Stacey Skura Zedeck
Open Actively Recruiting

Clarifying the Optimal Application of SLT Therapy Trial

The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Karina Lozano
Investigator:
JUDY LYNN CHEN
Open Actively Recruiting

A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)

This is a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis will receive zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period allows patients to receive zetomipzomib (KZR-616) for an additional 24 weeks of treatment.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Marco Morcos
Open Actively Recruiting

A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV

The study is being conducted to determine if cenicriviroc mesylate (CVC) will decrease vascular inflammation as measured by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) imaging of the aorta.

Phase: Phase II/III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Lisa Mark
Open Actively Recruiting

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

The purpose of this study is to evaluate the efficacy and safety of selinexor as a maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have achieved a partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks of platinum-based therapy. A total of 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Surya Nagesh
Open Actively Recruiting

DMCRN-02-001: Assessing Pediatric Endpoints in DM1

The overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and childhood myotonic dystrophy type 1, and develop biomarkers for the condition.

Gender: All
Age Group: Children
Contact: Merve Kaleli
Open Actively Recruiting

Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema

The goal of the LEOPARD clinical trial is to investigate a new kind of steroid eye drops, OCS-01.

Macular edema is a condition in which there is collection of fluid (edema) in the back of the eye (Macula) and it can lead to severe loss of vision. Among other causes, macular edema can happen because of a disease of the eye called Uveitis, and also after eye surgery. Treatment of macular edema remains a challenge as the condition may persist for several months and may lead to irreversible changes in the eye and poor vision. In the LEOPARD study the investigators wish to see how safe is the study drug (OCS-01) and how well it works, in resolving the fluid collection in the eye in patients with Uveitis or in patients who have had eye surgery. Participants will undergo detailed eye exam, and record their eye and medical history to see what their disease status is and if they can be included in the study based on the study criteria. If included, they will take the study drug OCS-01 in different doses for 24 weeks. During the study period, they will have regular eye exams to ensure their safety and to assess the usefulness of the study drug.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Joseph Privratsky
Investigator: Edmund Tsui, MD
Open Actively Recruiting

Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, multi-center, single-dose, pharmacodynamic study designed to evaluate the efficacy and safety of the combination product (VNX001) versus placebo and its individual components (heparin sodium and lidocaine hydrochloride (HCl)) for the reduction of bladder pain in patients with interstitial cystitis (IC) / bladder pain syndrome (BPS).

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: ANNE ACKERMAN
Open Actively Recruiting

A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease

The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718 softgel lipid capsule in participants with Huntington's Disease (HD)

Phase: Phase III
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Aaron Fisher
Open Actively Recruiting

MRI for radiotherapy guidance and response assessment

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: Christine Palodichuk
Investigator:
Daniel Low
Open Actively Recruiting

PBMC Collection in Healthy Donors

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Jacob Naparstek
Investigator:
CRISTINA PUIG SAUS
Open Actively Recruiting

A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer

The goal of this clinical trial is to test if the addition of botensilimab to standard chemotherapy improves the efficacy compared to just chemotherapy alone in participants with metastatic pancreatic cancer. One group of participants will only receive chemotherapy while a second group of participants will receive botensilimab and chemotherapy.

Phase: Phase II
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Aricka Fayton
Investigator:
Randolph Hecht
Open Actively Recruiting

The Role of Hydrogen Sulfide in Postoperative Atrial Fibrillation after Cardiac Surgery

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Jennifer Scovotti