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Активно (без набиране) Фаза 2

Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder

REM Sleep Behavior Disorder

This study is to investigate the safety and efficacy of PXS-4728A as an intervention therapy in participants with iRBD. This study will be conducted in participants aged 50 to 80 years of age and will investigate a single dose level.

Начало: 08.11.2023 Край: 31.01.2026 Възраст: 50–80 г. Лечение

Australia, United Kingdom Syntara NCT05904717

Активно (без набиране) Фаза 1/2

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT

Prostate Cancer

This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, \[225Ac\]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients. Enrollment of all participants was not completed. The evaluated radioligand showed acceptable safety but limited benefit in metastatic prostate cancer

Начало: 07.11.2023 Край: 05.11.2029 Възраст: 18–100 г. Лечение

Australia, Canada, France +1 Novartis Pharmaceuticals NCT05983198

Активно (без набиране) Фаза 3

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Chronic Kidney Disease With High Proteinuria

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria

Начало: 07.11.2023 Край: 18.02.2027 Възраст: 18–95 г. Лечение

Argentina, Australia, Brazil +25 AstraZeneca NCT06087835

Активно (без набиране) Фаза 1

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: * can a dose of JNJ-90009530 be determined that is safe and well tolerated by patients. * will JNJ-90009530 help patients achieve a response and for how long?

Начало: 06.11.2023 Край: 03.01.2040 Възраст: от 18 г. Лечение

Australia, Israel, United Kingdom +1 Janssen Research & Development, LLC NCT05784441

Активно (без набиране) Фаза 3

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.

Ulcerative Colitis

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.

Начало: 06.11.2023 Край: 01.10.2033 Възраст: 2–17 г. Лечение

Australia, Belgium, Brazil +20 AbbVie NCT05782907

Активно (без набиране) Фаза 3

The ENERGY 3 Study: Evaluation of Efficacy and Safety of INZ-701 in Children With ENPP1 Deficiency

Ectonucleotide Pyrophosphatase/Phosphodiesterase1 Deficiency Autosomal Recessive Hypophosphatemic Rickets Generalized Arterial Calcification of Infancy

The primary purpose of Study INZ701-106 (The ENERGY 3 Study) is to assess the efficacy and safety of INZ-701 in children with ENPP1 Deficiency.

Начало: 05.11.2023 Край: 01.02.2026 Възраст: 1–12 г. Лечение

Australia, Canada, France +6 Inozyme Pharma NCT06046820

Активно (без набиране) Фаза 1

A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old

Lupus Nephritis

In this study, researchers will learn more about the use of felzartamab in people with active lupus nephritis, also known as LN. In people with LN, antibodies build up in the glomeruli of the kidneys. Antibodies are proteins in the blood used by the immune system to fight infection. Glomeruli are small filters that remove waste and extra fluid from the blood. This buildup leads to inflammation and damage to the kidneys. Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with LN. Symptoms of LN can include fever, swelling in the legs and body, and high blood pressure. If left untreated, LN can eventually lead to kidney failure. In this study, researchers will learn more about how a study drug called felzartamab affects people with LN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to learn more about the safety of felzartamab and how it works in the body of people with LN who are taking standard of care. This will help researchers decide if they should do more studies with felzartamab in people with LN. Standard of care is the usual treatment or care given to patients for a disease, as prescribed by their doctor. The main question researchers want to answer in this study are: • How many participants had adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug. It can happen during a clinical study or within a certain amount of time after the study has ended. Researchers will also learn more about: * How much felzartamab affects proteinuria and the level of creatinine in the urine. Creatinine is a protein that is released into the blood from normal muscle wear and tear. Its levels can help doctors understand how well your kidneys are working. * How many participants have a complete response. A complete response means that their urine protein levels decrease to a low level, and their kidney function stays stable. * How many participants have a 50% decrease in the level of protein and creatinine in their urine. * How much felzartamab affects the participants' lupus-related blood tests. * How the body processes felzartamab. * How many participants develop antibodies against felzartamab in the blood. This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 42 days. * Throughout the study, all participants will continue taking their standard of care, as prescribed by their doctor. * There are 2 parts in this study. In both parts, participants will receive felzartamab through an intravenous infusion, also known as an IV. This means it is being given into a vein. * In Part 1, participants will have up to 14 visits to their study research center. In Part 2, participants may have up to 15 visits. * Each participant will be in the study for about 2 years.

Начало: 01.11.2023 Край: 30.06.2026 Възраст: 18–75 г. Лечение

Argentina, Australia, Canada +1 HI-Bio, A Biogen Company NCT06064929

Активно (без набиране) Фаза 2/3

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Metastatic Uveal Melanoma

This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A\*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

Начало: 31.10.2023 Край: 15.01.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +10 IDEAYA Biosciences NCT05987332

Активно (без набиране) Фаза 2

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes

Type 1 Diabetes Mellitus

The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.

Начало: 30.10.2023 Край: 31.03.2029 Възраст: 8–45 г. Лечение

Australia, United States National Institute of Diabetes and Digestive and Kidney NCT03929601

Активно (без набиране) Фаза 2

A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive

Advanced Solid Tumor

This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.

Начало: 30.10.2023 Край: 22.07.2026 Възраст: от 18 г. Лечение

Brazil, China, Georgia +6 Incyte Corporation NCT05879822

Активно (без набиране) Фаза 3

A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Sjogrens Syndrome

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).

Начало: 27.10.2023 Край: 22.04.2033 Възраст: 18–75 г. Лечение

Argentina, Australia, Belgium +30 Novartis Pharmaceuticals NCT05985915

Активно (без набиране) Фаза 3

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

Thyroid Eye Disease TED

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

Начало: 26.10.2023 Край: 01.07.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Germany +6 Hoffmann-La Roche NCT05987423

Активно (без набиране) Фаза 3

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.

Начало: 25.10.2023 Край: 01.08.2029 Възраст: 16–80 г. Лечение

Argentina, Australia, Belgium +39 Merck Sharp & Dohme LLC NCT06052059

Активно (без набиране) Фаза 3

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

Metastatic Non-small Cell Lung Cancer

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 \< 50%.

Начало: 24.10.2023 Край: 23.03.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 AstraZeneca NCT05984277

Активно (без набиране) Фаза 2

A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa

This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.

Начало: 23.10.2023 Край: 01.08.2026 Възраст: 18–75 г. Лечение

Australia, Canada, Germany +3 Eli Lilly and Company NCT06046729

Активно (без набиране) Фаза 2

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Waldenstrom Macroglobulinemia Waldenstrom's Macroglobulinemia Recurrent Waldenstrom's Macroglobulinemia Refractory

This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.

Начало: 23.10.2023 Край: 01.08.2028 Възраст: от 18 г. Лечение

Australia, Canada, China +6 BeOne Medicines NCT05952037

Активно (без набиране) Фаза 4

A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

Generalized Pustular Psoriasis

This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

Начало: 22.10.2023 Край: 14.08.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +14 Boehringer Ingelheim NCT06013969

Активно (без набиране) Фаза 2

Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease

Alzheimer's Disease

The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment \[MCI\] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

Начало: 20.10.2023 Край: 23.11.2026 Възраст: 50–85 г. Лечение

Argentina, Australia, Canada +13 GlaxoSmithKline NCT06079190

Активно (без набиране) Фаза 2

Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)

Diabetes Mellitus, Type 1

A multi-center, placebo-controlled, double blind, 1:1:1 randomized control clinical trial testing two different JAK Inhibitors abrocitnib, ritlecitinib, and placebo in subjects with recent onset Stage 3 Type 1 Diabetes within 100 days of diagnosis.

Начало: 19.10.2023 Край: 30.06.2027 Възраст: 12–35 г. Лечение

Australia, Canada, United States National Institute of Diabetes and Digestive and Kidney NCT05743244

Активно (без набиране) Фаза 1

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

Healthy

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.

Начало: 16.10.2023 Край: 01.07.2025 Възраст: 26–55 г. Лечение

Australia Tyra Biosciences, Inc NCT06006702

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