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NCT ID: NCT05782907 Recruiting - Ulcerative Colitis Clinical Trials

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Start date: November 6, 2023
Phase: Phase 3
Study type: Interventional

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. 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.

NCT ID: NCT05775159 Recruiting - Clinical trials for Hepatocellular Carcinoma

Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

Start date: April 24, 2023
Phase: Phase 2
Study type: Interventional

GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.

NCT ID: NCT05774951 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

CAMBRIA-1
Start date: March 31, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

NCT ID: NCT05771480 Recruiting - Clinical trials for Biliary Tract Cancer

Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)

TOURMALINE
Start date: August 16, 2023
Phase: Phase 3
Study type: Interventional

A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.

NCT ID: NCT05769777 Recruiting - Dermatitis Atopic Clinical Trials

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

ATLANTIS
Start date: April 3, 2023
Phase: Phase 2
Study type: Interventional

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 180 weeks, including: - A screening period of up to 2 to 4 weeks - An open label treatment period of up to 160 weeks (approximately 3 years) - A post-treatment safety follow-up period of at least 20 weeks after the last dose administration The planned number of visits will be 26 visits.

NCT ID: NCT05767034 Recruiting - Clinical trials for Polymyalgia Rheumatica

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

REPLENISH
Start date: March 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

NCT ID: NCT05765734 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of TAS3351 in NSCLC Patients With EGFRmt

TAS3351
Start date: May 3, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

NCT ID: NCT05760989 Recruiting - Clinical trials for Cardiovascular Diseases

TRISCEND JAPAN Study

TRISCEND JAPAN
Start date: February 6, 2023
Phase: N/A
Study type: Interventional

A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.

NCT ID: NCT05757869 Recruiting - Atrial Fibrillation Clinical Trials

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

LIBREXIA-AF
Start date: April 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.

NCT ID: NCT05755386 Recruiting - IC-MPGN Clinical Trials

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

APPARENT
Start date: October 2, 2023
Phase: Phase 3
Study type: Interventional

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.