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NCT ID: NCT06224348 Recruiting - Dermatitis Atopic Clinical Trials

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

SHORE
Start date: January 18, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

NCT ID: NCT06224309 Not yet recruiting - Multiple Myeloma Clinical Trials

Preliminary Assessment of [18F]BL40 in PET/CT Scans

Start date: May 2024
Phase:
Study type: Observational [Patient Registry]

CXCR4 is type of receptor that has been detected in more than twenty different subtypes of cancers. Most of these cancers are associated with negative symptoms that worsen over time resulting in great disability and poor function. There is a need for novel tracers to image CXCR4-expressing tumors for better detection, staging, and monitoring of aggressive cancers without the need for invasive biopsy procedures that may not always properly capture the extent of a patient's disease. This study looks to assess the safety and efficacy of a novel radiopharmaceutical known as 18F-BL40 through its use in a PET/CT scan. Participants will receive 2 PET/CT scans: 18F-BL40 and 18F-FDG as part of this study.

NCT ID: NCT06224192 Recruiting - Atopic Dermatitis Clinical Trials

A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD

ROCKET-Outpost
Start date: April 2, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.

NCT ID: NCT06223789 Recruiting - Atrial Fibrillation Clinical Trials

VOLT-AF IDE Clinical Study

Start date: April 3, 2024
Phase: N/A
Study type: Interventional

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

NCT ID: NCT06222827 Recruiting - Clinical trials for Facioscapulohumeral Muscular Dystrophy 1

Study to Evaluate the Efficacy and Safety of Satralizumab in FSHD1

REINFORCE
Start date: January 24, 2024
Phase: Phase 2
Study type: Interventional

Facioscapulohumeral muscular dystrophy (FSHD) is characterized by clinical diversity, with FSHD1 being the most common form. It is associated with a toxic gain of function of the Double homeobox 4 (DUX4) gene, leading to muscle cell death and weakness. Despite the lack of approved treatments, recent studies highlight inflammation's role in early FSHD progression, triggered by inappropriate DUX4 expression. In understanding inflammation's pivotal role in FSHD, a study assessed serum cytokines in 100 adult FSHD1 patients. Out of the 20 cytokines examined, 10 showed significantly altered expression levels compared to healthy controls of similar age and sex. FSHD1 patients exhibited heightened levels of inflammatory cytokines and diminished anti-inflammatory cytokines, signaling chronic inflammation. Notably, Interleukin-6 (IL-6) emerged as a promising disease activity biomarker, displaying robust correlations with established clinical severity and functional scores. Given the pathological significance of inflammation and the correlation of IL-6 levels with disease severity, the ReInForce study will explore the satralizumab, an IL6-receptor (IL6-R) antagonist, for its efficacy in specifically reducing muscle and systemic inflammation. By antagonizing IL-6R downstream signaling, satralizumab holds promise in mitigating inflammation and potentially curtailing fibrofatty degeneration in FSHD.

NCT ID: NCT06222788 Not yet recruiting - Breast Cancer Clinical Trials

Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the safety of the use of non-thermal plasma (NTP, an ionized gas) on the tumor bed after the removal of the tumor in breast cancer patients. The main questions it aims to answer are: - To determine the safe and tolerable dose of NTP in patients with breast cancer; - To assess the safety and tolerability of NTP; - To assess the cosmetic effects of NTP treatment in patients with breast cancer. Participants will receive one treatment of the tumor bed after the removal of their breast tumor.

NCT ID: NCT06221969 Recruiting - Type 2 Diabetes Clinical Trials

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Start date: January 16, 2024
Phase: Phase 3
Study type: Interventional

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

NCT ID: NCT06221358 Recruiting - Clinical trials for Attention-Deficit/ Hyperactivity Disorder (ADHD)

Pharmacogenomics of Stimulant Treatment Response

PGx-STaR
Start date: April 1, 2024
Phase:
Study type: Observational

The "Pharmacogenomics of Stimulant Treatment Response" (PGx-STaR) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-17 with Attention deficit/hyperactivity disorder (ADHD).

NCT ID: NCT06220604 Recruiting - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

Start date: March 9, 2024
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.

NCT ID: NCT06220526 Recruiting - Clinical trials for Suspected Sarcoidosis

Comparing Menghini-type Needle and Franseen-type Needle in EBUS-TBNA for Sarcoidosis

Start date: August 18, 2023
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial aims to examine whether sample collection with Franseen-type needles are effective for the diagnosis of sarcoidosis, as defined by improved sample quality for pathological diagnosis compared to the conventional Menghini-type needle.