Search Clinical Trials
| Sponsor Condition of Interest |
|---|
|
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Isch1
Dompé Farmaceutici S.p.A
Non-Arteritic Anterior Ischemic Optic Neuropathy
This is a phase 3, randomized, multicenter, vehicle-controlled, double-masked study to
evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control
in adult participants with NAION. Approximately 272 participants who meet all eligibility
criteria will be randomly assigned1 expand
This is a phase 3, randomized, multicenter, vehicle-controlled, double-masked study to evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION. Approximately 272 participants who meet all eligibility criteria will be randomly assigned in a 1:1 ratio to receive either cenegermin treatment (Group 1) or the vehicle control (Group 2). Type: Interventional Start Date: Jul 2026 |
|
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervent1
Supira Medical
Coronary Artery Disease
High Risk Percutaneous Coronary Intervention
Interventional Cardiology
Mechanical Circulatory Support
The objective of this study is to assess the safety and efficacy of the Supira System in
providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
Eligible patients will be randomized to undergo HRPCI with either the Supira System
(investigational device) or the commercia1 expand
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device). Type: Interventional Start Date: May 2026 |
|
CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma
Washington University School of Medicine
Moderate to Severe Asthma
Purpose: This study aims to improve asthma care by helping clinicians at community health
centers prescribe a guideline-recommended treatment called SMART (Single Maintenance and
Reliever Therapy).
The investigators will provide training and resources to clinicians, give feedback on
prescribing pa1 expand
Purpose: This study aims to improve asthma care by helping clinicians at community health centers prescribe a guideline-recommended treatment called SMART (Single Maintenance and Reliever Therapy). The investigators will provide training and resources to clinicians, give feedback on prescribing patterns, and offer educational tools for patients and providers. The investigators will roll out these resources in stages across clinics. The study will measure how well the program helps clinicians prescribe SMART therapy and whether it reduces asthma exacerbations in patients. Type: Interventional Start Date: Jan 2026 |
|
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Mu1
Takeda
Multiple Myeloma
Secondary Immunodeficiency
Multiple myeloma is a cancer of the plasma cells in the bone marrow.
The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10
percentage (%) (IGI, 10%) can help prevent infections in participants with multiple
myeloma receiving B-cell maturation antigen (BCMA) x clu1 expand
Multiple myeloma is a cancer of the plasma cells in the bone marrow. The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy. Participants will be randomly assigned to one of two groups: 1. Primary infection prevention group: They will receive IGI, 10% for 12 months. 2. Secondary infection prevention group: They will only receive IGI, 10% if they develop a serious infection during the 12 months study period. During the study, participants will visit their study clinic 15 times (for 4-week dosing interval) or 19 times (for 3-week dosing interval) and their total participation duration will be up to 14 months (including screening period approximately 8 weeks). Type: Interventional Start Date: Jan 2026 |
|
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multip1
Celgene
Multiple Sclerosis Spasticity
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986368 in participants with Multiple Sclerosis Spasticity expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity Type: Interventional Start Date: Jun 2025 |
|
Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Pati1
M.D. Anderson Cancer Center
Chronic Pancreatitis
Exocrine Pancreas Carcinoma
Recurrent Acute Pancreatitis
This clinical trial collects blood, saliva, urine, or stool samples to help identify
possible genetic mutations that may increase a person's chance at developing pancreatic
cancer. Finding genetic markers among pediatric patients with acute recurrent
pancreatitis and chronic pancreatitis may help i1 expand
This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer. Type: Observational Start Date: Apr 2021 |
|
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Ad1
Angiex, Inc.
Cancer
Advanced Cancer
Locally Advanced Carcinoma
Metastatic Solid Tumor
Breast Cancer
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose
of this study is to learn about AGX101 effects and safety at various dose levels in an
all-comers advanced solid cancer patient population. AGX101will be administered
intravenously.
Dosing of AGX101 will be r1 expand
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously. Dosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug. Type: Interventional Start Date: Jul 2024 |
|
CoMind Early Feasibility Study
CoMind Technologies Limited
Intracranial Pressure
Intracranial Pressure Changes
Traumatic Brain Injury
Intracerebral Hemorrhage
Encephalitis
The purpose of this research, which has been determined as non-significant risk by the
central IRB overseeing the study, is to obtain information to help further develop a
machine (a medical device) to measure the pressure around the brain from the outside
(this pressure is called intracranial pres1 expand
The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain. Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices. Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP. Type: Observational Start Date: Nov 2024 |
|
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Vedanta Biosciences, Inc.
Clostridium Difficile
Clostridium Difficile Infections
Clostridium Difficile Infection Recurrence
Clostridioides Difficile Infection
Clostridioides Difficile Infection Recurrence
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the
Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who
receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are
identical for Stage 1 (recurrent CDI) and1 expand
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI). Type: Interventional Start Date: May 2024 |
|
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic D1
Washington University School of Medicine
Pancreatic Cancer
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at
5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone
have shown improvement in local control, initial invigoration of immune response, and
relief of symptom burden, SBRT has1 expand
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression). This study exploits the window of opportunity post-chemotherapy to advance the hypothesis that the addition of STAT3 inhibition in combination with SBRT will be safe and will enhance 2-year progression-free survival. Type: Interventional Start Date: Jan 2024 |
|
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine The1
NRG Oncology
Breast Cancer
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with es1 expand
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). Type: Interventional Start Date: Oct 2023 |
|
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
Varian, a Siemens Healthineers Company
Prostate Cancer
This trial is a prospective, single-arm, multi-center clinical trial designed to assess
whether adaptive radiotherapy with urethral sparing for low to intermediate risk
localized prostate cancer will translate into a decreased rate of patient reported acute
urinary side effects, as measured by the1 expand
This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT. Type: Interventional Start Date: Apr 2023 |
|
Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia
University of Colorado, Denver
Barretts Esophagus With Dysplasia
Barrett Esophagus
Esophageal Adenocarcinoma
The purpose of this study is to learn the best approach to treating patients with known
or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic
eradication therapy.
To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use
procedures calle1 expand
The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy. To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments. While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other. Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia. This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data. Type: Interventional Start Date: Jan 2023 |
|
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
Medical University of South Carolina
Head and Neck Cancer
Body Image Disturbance
Body Image
Survivorship
Psychosocial Impairment
In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with
clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a
brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a
manualized tele-supportive care1 expand
In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) will be randomized to BRIGHT (a brief video tele-cognitive behavioral therapy intervention) or Attention Control (AC, a manualized tele-supportive care intervention that controls for professional attention, dose, delivery method, and common factors). HNC survivors will complete IMAGE-HN (a validated patient-reported outcome measure [PROM] of HNC-related body image distress [BID]; primary endpoint), measures of psychological and social well-being and quality of life (QOL), and measures of theory-derived mechanisms of change underlying BRIGHT (mediators). Type: Interventional Start Date: Feb 2023 |
|
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturi1
A2 Biotherapeutics Inc.
Solid Tumor, Adult
Colorectal Cancer
Non Small Cell Lung Cancer
Pancreatic Cancer
CRC
Objective:
To collect information on how often a solid tumor cancer might lose the Human Leukocyte
Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an
eligible participant's own T cells for future use to make CAR T-Cell therapy for their
disease treatment.
De1 expand
Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer. Type: Observational Start Date: Oct 2021 |
|
A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walkin1
Boston University Charles River Campus
Parkinson's Disease (PD)
The purpose of this research study is to examine the effects of a 3-month personalized
community-based walking program using a digital music-based device designed for
self-directed gait training in people with Parkinson disease (PD). The study uses music
cues delivered through this digital device t1 expand
The purpose of this research study is to examine the effects of a 3-month personalized community-based walking program using a digital music-based device designed for self-directed gait training in people with Parkinson disease (PD). The study uses music cues delivered through this digital device to improve walking outcomes. The investigators want to know if personalized music cueing through the digital device can improve walking quality, walking ability, daily walking amount and intensity, and quality of life, while helping walking feel more automatic and require less mental effort. Participants will take part in this research study for approximately 18 weeks in total. During this time, participants will complete 4 study visits at designated research centers at Boston University, Washington University in St. Louis, or the University of Utah, depending on the site of enrollment. Type: Interventional Start Date: Aug 2026 |
|
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Verastem, Inc.
Pancreatic Ductal Adenocarcinoma (PDAC)
G12D Mutated KRAS
This study will assess the safety and efficacy of VS-7375 alone and in combination with
cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer expand
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer Type: Interventional Start Date: Jun 2026 |
|
Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients
Satellos Bioscience, Inc.
Duchenne Muscular Dystrophy
Duchenne
DMD
Neuromuscular Diseases
Muscular Dystrophies
Phase 2a trial of SAT-3247 in ambulatory DMD patients aged ≥ 7 and < 10 years. The trial
has two parts. In Part 1, the trial will study two doses of SAT-3247 in a randomized,
double-blind, placebo-controlled weekday regimen for 12 weeks to determine the optimal
dose, safety, tolerability, and preli1 expand
Phase 2a trial of SAT-3247 in ambulatory DMD patients aged ≥ 7 and < 10 years. The trial has two parts. In Part 1, the trial will study two doses of SAT-3247 in a randomized, double-blind, placebo-controlled weekday regimen for 12 weeks to determine the optimal dose, safety, tolerability, and preliminary efficacy. In Part 2, the trial will study two doses of SAT-3247 for an additional 9 months. Type: Interventional Start Date: Dec 2025 |
|
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
Joseph Broderick, MD
Intracerebral Hemorrhage
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time
(FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral
hemorrhage (ICH) within a time window and subgroup of patients that is most likely to
benefit. The central hypothesis is tha1 expand
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. Type: Interventional Start Date: May 2025 |
|
Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymo1
University of California, San Francisco
Posterior Fossa Ependymal Tumor
This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in
children and young adults with recurrent or progressive Posterior Fossa Group A (PFA)
ependymoma. expand
This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma. Type: Interventional Start Date: May 2026 |
|
AI-driven Clinical Decision Support for Perioperative Blood Orders
Washington University School of Medicine
Surgery
20 million patients have surgery in the United States every year, with approximately 1
million of those patients requiring life-saving blood transfusion. Presurgical
preparation for transfusion is important to allow for safe and timely transfusion during
surgery; however, excessive preparation is u1 expand
20 million patients have surgery in the United States every year, with approximately 1 million of those patients requiring life-saving blood transfusion. Presurgical preparation for transfusion is important to allow for safe and timely transfusion during surgery; however, excessive preparation is unfortunately common, costly, and contributes to blood waste. This study aims to evaluate an intelligent clinical decision support system that helps clinicians prepare blood for patients who are likely to need it, while avoiding excessive preparation for patients who don't, potentially improving patient safety while reducing blood waste and healthcare costs. Type: Interventional Start Date: Oct 2025 |
|
Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Scree1
Washington University School of Medicine
Lung Cancer
Cancer of the Lung
Inspired by the ongoing Pink & Pearl Campaign, the breast radiology service of Christian
Hospital in north St. Louis County will partner with Siteman Cancer Center to pilot this
campaign in its mammography clinics in order to promote awareness, referral, and
completion of lung cancer screening (LCS1 expand
Inspired by the ongoing Pink & Pearl Campaign, the breast radiology service of Christian Hospital in north St. Louis County will partner with Siteman Cancer Center to pilot this campaign in its mammography clinics in order to promote awareness, referral, and completion of lung cancer screening (LCS) among eligible women. This campaign leverages established infrastructure such as nurse navigation and referral to screening or primary care for further shared decision-making on cancer screening. The purpose of this study is to evaluate the effectiveness of the Pink & Pearl Campaign in improving LCS uptake among LCS-eligible women undergoing mammography at Christian Hospital. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, our specific aims for this proposal are to: a) assess whether the Pink & Pearl Campaign increases referrals and uptake/completion of LCS among LCS-eligible women undergoing screening mammography; b) determine median time-to-screening after referral to LCS; and c) evaluate individual and health system factors influencing LCS uptake and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS. Type: Interventional Start Date: Feb 2026 |
|
Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Int1
Washington University School of Medicine
Prostate Cancer
Cancer of the Prostate
- The investigators propose a clinical trial to evaluate the impact of annual shared
decision making for PSA screening, supported by system-level enhancements to promote
evidence-based care:
- Defined referral thresholds within the health maintenance reminder, aligned with
clinical risk st1 expand
- The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care: - Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines. - Enhanced clinical decision support (CDS) tools to reduce provider variation and ensure guideline-concordant screening and referral practices. - The goal is to reduce late-stage presentation without increasing overdiagnosis-ensuring that prostate cancer screening is both accessible and clinically effective. Type: Interventional Start Date: Aug 2025 |
|
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung1
Washington University School of Medicine
Antibody Mediated Rejection of Lung Transplant
Antibody-mediated rejection after lung transplantation commonly results in allograft
failure and death in spite of current therapeutic regimens. We are testing the safety and
tolerability of the addition of a novel immunosuppressive medication to routine treatment
for antibody-mediated rejection. F1 expand
Antibody-mediated rejection after lung transplantation commonly results in allograft failure and death in spite of current therapeutic regimens. We are testing the safety and tolerability of the addition of a novel immunosuppressive medication to routine treatment for antibody-mediated rejection. Future studies will be needed to assess efficacy if this study demonstrates safety Type: Interventional Start Date: Nov 2025 |
|
ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With1
Calico Life Sciences LLC
Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of
kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of
this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of
ADPKD in adult participants.
ABBV-CL1 expand
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants. ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide. Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Jun 2025 |