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NCT ID: NCT06012240 Recruiting - Alopecia Areata Clinical Trials

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Up-AA
Start date: October 11, 2023
Phase: Phase 3
Study type: Interventional

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 240 sites worldwide. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose. 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: NCT06008756 Recruiting - Arteriosclerosis Clinical Trials

MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Start date: October 9, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

NCT ID: NCT06008652 Recruiting - Clinical trials for Healthy Adult Volunteers

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers

Start date: November 26, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy volunteers.

NCT ID: NCT06008249 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS)

Start date: August 9, 2021
Phase: Phase 3
Study type: Interventional

The objective of this phase III, placebo-controlled platform study is to investigate the efficacy of drugs for patients with ALS (Amyotrophic lateral sclerosis).

NCT ID: NCT06007690 Recruiting - Uveal Melanoma Clinical Trials

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

CoMpass
Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

NCT ID: NCT06007482 Recruiting - Clinical trials for Advanced Solid Tumor

A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors

Start date: September 7, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ES009 administered intravenously to subjects with advanced solid tumors.

NCT ID: NCT06006702 Recruiting - Healthy Clinical Trials

A Relative Bioavailability and Food Effect Study of TYRA-300-B01 Capsule and Tablet Formulations in Healthy Adult Participants

Start date: October 16, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the relative bioavailability of capsule and tablet formulations of TYRA-300-B01, and to evaluate the safety, tolerability, and food effect of TYRA-300-B01 tablets in healthy adult participants.

NCT ID: NCT06005220 Recruiting - Clinical trials for Rheumatoid Arthritis

SBD121, a Synbiotic Medical Food for RA Management

Start date: September 30, 2023
Phase: N/A
Study type: Interventional

The aim of this randomised, double-blind, placebo controlled clinical food trial is to determine if the medical food SBD121 Synbiotic (prebiotic and probiotic) will aid in the dietary management of symptoms of early rheumatoid arthritis (RA).

NCT ID: NCT06003621 Recruiting - Solid Tumor, Adult Clinical Trials

Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients

MoST-TAP
Start date: December 15, 2023
Phase: Phase 2
Study type: Interventional

This phase II study will explore the effect of 2 monoclonal antibodies, tiragolumab and atezolizumab, in patients with locally advanced solid cancers which cannot be removed by surgery or have spread. Their cancers will have characteristics which may predict immune response to the study treatment. PD-L1 and TIGIT are immune receptors which can help cancers grow by evading the immune response and inhibiting the action of some immune cells. By blocking these receptors, tiragolumab and atezolizumab may work together to re-activate the body's anti-tumour immune response and kill cancer cells.

NCT ID: NCT06003426 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Start date: September 14, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.