Trials Today

Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation. Double-blind treatment will be initiated 10 - 14 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks. The objective is to assess whether patients who discontinue therapy with an IL-1 blocker for recurrent pericarditis remain free of pericarditis recurrence while receiving CardiolRx.

Type: Interventional

Start Date: Apr 2025

open study

Brief motivational interviewing intervention to address alcohol use among diverse teens 12-17.

Type: Interventional

Start Date: Apr 2025

open study

The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP)

Type: Interventional

Start Date: Jun 2025

open study

To find the highest tolerable dose and recommended dose of PRAME-TCR-NK cells that can be given to participants with recurrent and/or refractory melanoma. The safety and tolerability of PRAME-TCR-NK cells will also be studied.

Type: Interventional

Start Date: Feb 2025

open study

The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms

Type: Interventional

Start Date: Dec 2024

open study

Purpose: Aim 1: Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members. Aim 2: Compare the validated domains, such as functional, quality of life and pain scores, from the preoperative baseline to follow-up visits to determine if persons with transtibial amputations treated with OPRA osseointegrated prostheses demonstrate statistically significant and clinically relevant improvements. Aim 3: Compare physical performance measures preoperatively to follow-up visits for persons with transtibial amputations treated with OPRA osseointegrated prostheses to quantify statistically significant and clinically relevant improvements. Aim 4: Quantify the biomechanical loading and bone quality changes that are directly associated with patient reported outcomes for persons with transtibial amputations treated with OPRA osseointegration. Aim 5: Compare outcome measures between persons with traditional socket prostheses (patients as self-controls) and OPRA OI devices as well as a comparison between persons with transtibial OI and transfemoral OI. Subject Population: Male and female military health care beneficiaries age 22 to 65 years old presenting with a Transtibial limb loss. Study Design: This is a 4-year, prospective cohort FDA pivotal study involving off-label use of the OPRA OI implant in persons with transtibial amputation. Procedures: SURGICAL PROCEDURES: Surgery Stage I: The distal part of the tibia is exposed, preferably using existing incisions, to produce an appropriate fasciocutaneous flap. By the use of fluoroscopy and guiding devices the correct position of the fixture in the medullary canal is found. The canal is reamed step by step to a proper diameter to facilitate insertion of the implant. If the bone quality is poor, as determined by the operating surgeon, autologous bone graft from the iliac crest and/or the medullary canal is used. The fixture is then implanted into the intramedullary canal. Careful surgical technique is essential not to damage the tissue and to achieve osseointegration. A central screw, healing cylinder, and healing bolt are inserted. A myodesis is performed, and the wound is closed using suture. The sutures are removed 2-3 weeks postoperatively. When the skin is completely healed the Patient's conventional socket prosthesis could, in some instances, be used. Surgery Stage II (3-5 months after Stage I): The tibia is exposed via the incision from the Stage I-Surgery. The healing cylinder is removed and the tissues are trimmed in a way that the distal end of the bone protrudes a few millimeters. The skin will be attached directly to it. The endosteal canal is reamed to facilitate placement of the abutment. The skin in the abutment area is then trimmed to a diameter equal to the protruding end of the tibia. This is done to remove the subcutaneous fat and facilitate healing of the dermal layer to the distal end of the bone. The subcutaneous tissue is affixed to the periosteum using absorbable suture to prevent skin movement. A 8mm punch biopsy tool is used to create a circular hole in the skin precisely over the residual tibial canal. The remaining portion of the fasciocutaneous flap is sutured into position. A bolster dressing is placed and routine postoperative wound care is performed by daily dressing changes. Sutures are removed 2-3 weeks postoperatively. CLINICAL PROCEDURES A pre-study visit will be conducted up to 6 months prior to Surgery Stage I. Postoperative visits will occur 2-3 weeks after each surgery. Additional follow-up visits will occur 6, 12, 24, 36, 48 and 60 months post-Surgery Stage II. It is standard of care to follow patients postoperatively from time to time to ensure the wound(s) is /are healing, surveil for complications, and ensure rehabilitation is progressing. That said, the sole reason for engaging in the Clinical Follow-Up Procedures is for the purpose of conducting research under this particular protocol. Additional visits may occur including x-rays at the discretion of the clinical investigator in order to monitor the participants medical status/bone healing. RESEARCH PROCEDURES Timepoints: Baseline, Post-Op Stage II, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months The patients will be assessed before and after the surgery regularly. Both performance and safety data will be recorded on specially designed electronic Case Report Forms (eCRFs). Clinical and radiological assessments are performed preoperatively (in connection with the surgical procedures.

Type: Interventional

Start Date: May 2025

open study

This study is open to adults who are at least 18 years old and have: - A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or - A confirmed liver disease called metabolic-associated steatohepatitis (MASH) - BMI of 27 kg/m2 or more or - 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Type: Interventional

Start Date: Dec 2024

open study

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm^2 to 80 cm^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Type: Interventional

Start Date: Feb 2025

open study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

Type: Interventional

Start Date: Oct 2024

open study

This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Type: Interventional

Start Date: Jan 2025

open study

The purpose of this research is to see how certain genetic variations relate to side effects and outcomes experienced while receiving treatment with azacitidine and venetoclax.

Type: Observational

Start Date: Apr 2025

open study

This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.

Type: Interventional

Start Date: Sep 2024

open study

This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize (improve) these levels in patients with estrogen receptor (ER) or progesterone receptor (PR) positive, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and are receiving CDK 4/6 inhibitors. CDK4/6 inhibitors in combination with endocrine therapy (ET) is first line treatment for metastatic hormone positive (ER/PR positive) breast cancer (mBC). Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division). DiviTum-thymidine kinase activity (TKa) is a Food and Drug Administration approved assay which showed that a TKa is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. Using the DiviTum-TKa may improve medication compliance and remove potential drug-drug interactions in patients with ER/PR positive HER2-negative MBC.

Type: Interventional

Start Date: Sep 2023

open study

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with nephritis (Subprotocol B) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

Type: Interventional

Start Date: Jun 2025

open study

To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.

Type: Interventional

Start Date: Jan 2025

open study

The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

Type: Interventional

Start Date: Jan 2025

open study

The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Type: Interventional

Start Date: Aug 2024

open study

In this observational study, researchers are looking at the effects of spinal muscular atrophy (SMA) drugs on the muscles and nerve cells in patients with SMA. Primary Objectives - To evaluate the feasibility and reliability of performing MR functional imaging in exercising muscle in patients with SMA. - To evaluate patients with SMA types 2 and 3 at baseline and longitudinally at 6 and 12 months Secondary Objectives - To describe the MR functional bioenergetics response in the leg muscles in four potential groups of patients with spinal muscular atrophy: untreated, actively treated with nusinersen (Spinraza®) or onasemnogene abeparvovec (Zolgensma®), actively treated with risdiplam (Evrysdi®), and switching from Spinraza or Zolgensma to Evrysdi. - To identify changes in motor function in patients with SMA types 2 and 3 who initiate treatment with risdiplam. - To obtain biomarkers in blood, urine, and muscle tissue to provide evidence for risdiplam effect on skeletal muscle. - To obtain quality of life and disability data from participants in this study.

Type: Observational

Start Date: Jul 2025

open study

The main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) of benralizumab.

Type: Interventional

Start Date: Apr 2025

open study

The objective of this study is to determine the safety and tolerability of vorasidenib in combination with temozolomide (TMZ) and to establish the recommended combination dose (RCD) of vorasidenib. The study will begin as a Phase Ib study to determine the RCD and then will transition to a Phase II study to assess the clinical efficacy of vorasidenib at the RCD in combination with TMZ. During the treatment period participants will have study visits on day 1 and 22 of each cycle, with additional visits occurring during the first cycle of the Phase 1b study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur and then participants will be followed for survival every 3 months. Study visits may include questionnaires, blood tests, ECG, vital signs, and a physical examination.

Type: Interventional

Start Date: Jan 2025

open study

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement. Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab. 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 clinical assessments, blood tests, checking for side effects and completing questionnaires.

Type: Interventional

Start Date: Aug 2024

open study

To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma.

Type: Interventional

Start Date: Nov 2024

open study

This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.

Type: Interventional

Start Date: May 2024

open study

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

Type: Interventional

Start Date: Oct 2024

open study

This study is researching an experimental drug called REGN10597 (called "study drug"). The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Type: Interventional

Start Date: Sep 2024

open study