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Recruiting Phase 3

A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks. Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks. Participants in the US that complete Periods 1 \& 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen. 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 and diaries.

Начало: 27.06.2024 Край: 01.12.2026 Възраст: от 12 г. Treatment

Argentina, Australia, Belgium +36 AbbVie NCT06468228

Recruiting Phase 3

Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

Generalized Myasthenia Gravis

The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period.

Начало: 25.06.2024 Край: 19.08.2030 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +19 Merck Healthcare KGaA, Darmstadt, Germany, an affiliate NCT06463587

Recruiting Phase 2

A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)

Stage II Nasopharyngeal Carcinoma AJCC v8 Stage III Nasopharyngeal Carcinoma AJCC v8 Stage IV Nasopharyngeal Carcinoma AJCC v8

This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.

Начало: 25.06.2024 Край: 31.12.2026 Възраст: до 21 г. Treatment

Canada, New Zealand, Puerto Rico +1 National Cancer Institute (NCI) NCT06064097

Recruiting Phase 3

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients

Head and Neck Squamous Cell Carcinoma

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.

Начало: 25.06.2024 Край: 01.03.2029 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +20 Merus B.V. NCT06496178

Recruiting Phase 3

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Cardiovascular Risk Acute Myocardial Infarction (AMI)

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

Начало: 25.06.2024 Край: 14.12.2026 Възраст: от 18 г. Treatment

Argentina, Australia, Brazil +20 Novo Nordisk A/S NCT06118281

Recruiting Phase 1

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

Locally Advanced or Metastatic Solid Tumors

This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.

Начало: 24.06.2024 Край: 01.10.2027 Възраст: от 18 г.

Canada, China, United States Avistone Biotechnology Co., Ltd. NCT06307795

Recruiting Phase 2/3

Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

Advanced Esophageal Adenocarcinoma Advanced Gastric Adenocarcinoma Advanced Gastroesophageal Junction Adenocarcinoma Clinical Stage II Esophageal Adenocarcinoma AJCC v8 +12

This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.

Начало: 24.06.2024 Край: 31.10.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06203600

Recruiting Phase 3

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Triple-Negative Breast Cancer

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Начало: 24.06.2024 Край: 14.12.2037 Възраст: от 18 г. Treatment

Argentina, Australia, Austria +28 Merck Sharp & Dohme LLC NCT06393374

Recruiting

The RECLAIM Study.

Chronic Migraine High Frequency Episodic Migraine

The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.

Начало: 24.06.2024 Край: 31.01.2029 Възраст: 18–84 г. Treatment

Australia, Belgium, Netherlands Salvia BioElectronics NCT06450444

Recruiting

External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial

Severe Traumatic Brain Injury Intracranial Hypertension

The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \

Начало: 24.06.2024 Край: 30.06.2028 Възраст: 18–65 г.

United States Brain Trauma Foundation NCT05889650

Recruiting

Cera™ Vascular Plug System Post-Market Clinical Follow-Up

Aneurysm Endoleak Pulmonary Arteriovenous Malformation Portal Hypertension +2

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: * confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks

Начало: 21.06.2024 Край: 01.12.2027 Възраст: 18–85 г.

Germany, Italy, Turkey (Türkiye) Lifetech Scientific (Shenzhen) Co., Ltd. NCT06099015

Recruiting Phase 1

A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias

Cardiovascular Metabolic Disease Dyslipidemias Lipid Disorder +6

This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.

Начало: 21.06.2024 Край: 01.06.2028 Възраст: 18–75 г. Treatment

Australia, New Zealand, United Kingdom +1 CRISPR Therapeutics AG NCT07491172

Recruiting Phase 2

Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma

The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival.

Начало: 21.06.2024 Край: 01.07.2036 Възраст: от 18 г. Treatment

Australia Melanoma Institute Australia NCT06288191

Recruiting Phase 1/2

A Phase I/II Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations

OTOF Gene Mutation DFNB9 Congenital Deafness Hearing Disorders +4

This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.

Начало: 21.06.2024 Край: 01.07.2031 Възраст: 6–31 г. Treatment

Australia, France Sensorion NCT06370351

Recruiting Phase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

Healthy Participants Healthy Subjects Healthy Volunteers Autoimmune Diseases +3

This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.

Начало: 20.06.2024 Край: 23.05.2026 Възраст: 18–75 г. Treatment

Australia, China, New Zealand BeiGene NCT06342713

Recruiting Phase 3

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Polymyositis, Dermatomyositis

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.

Начало: 20.06.2024 Край: 04.08.2028 Възраст: 18–75 г. Treatment

Argentina, Australia, Austria +26 AstraZeneca NCT06455449

Recruiting

Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia

Travelers Diarrhea

The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population.

Начало: 20.06.2024 Край: 01.07.2026 Възраст: 18–100 г.

Australia Lumen Bioscience, Inc. NCT06363890

Recruiting Phase 1/2

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

Colorectal Cancer Pancreatic Ductal Adenocarcinoma Biliary Tract Cancer

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn: * About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it * How many people have the cancer respond (get smaller or go away) to treatment

Начало: 20.06.2024 Край: 16.10.2029 Възраст: от 18 г. Treatment

Australia, Canada, Chile +10 Merck Sharp & Dohme LLC NCT06428409

Recruiting Phase 1/2

A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)

Alpha 1-Antitrypsin Deficiency

This is a Phase 1/2, multicenter, open-label, dose-exploration (Phase 1) and dose-expansion (Phase 2) study to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or liver disease and to determine the optimal biological dose (OBD).

Начало: 19.06.2024 Край: 01.05.2030 Възраст: 18–70 г. Treatment

Australia, Ireland, Netherlands +3 Beam Therapeutics Inc. NCT06389877

Recruiting Phase 3

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Glioblastoma GBM Brain Neoplasms, Adult, Malignant Brain Tumor

The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main question it aims to answer is: Does niraparib improve overall survival (OS) compared to TMZ? Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. * study drug (Niraparib) or * comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. Participants' tasks will include: * Complete study visits as scheduled * Complete a diary to record study medication

Начало: 19.06.2024 Край: 01.03.2028 Възраст: от 18 г. Treatment

Australia, Canada, France +8 Ivy Brain Tumor Center NCT06388733

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