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NCT ID: NCT05171777 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

Start date: April 4, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).

NCT ID: NCT05169567 Active, not recruiting - Neoplasm Metastasis Clinical Trials

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

postMONARCH
Start date: March 11, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

NCT ID: NCT05162586 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Start date: March 31, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.

NCT ID: NCT05156320 Active, not recruiting - Clinical trials for Neuromuscular Diseases

Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam

SAPPHIRE
Start date: February 24, 2022
Phase: Phase 3
Study type: Interventional

This Phase 3 trial (Study SRK-015-003) is being conducted in patients ≥2 years old at Screening, who were previously diagnosed with later-onset spinal muscular atrophy (SMA) (i.e., Type 2 and Type 3 SMA) and are receiving an approved survival motor neuron (SMN) upregulator therapy (i.e., either nusinersen or risdiplam), to confirm the efficacy and safety of apitegromab as an adjunctive therapy to nusinersen and evaluate the efficacy and safety of apitegromab as an adjunctive therapy to risdiplam.

NCT ID: NCT05156125 Active, not recruiting - Colitis, Ulcerative Clinical Trials

VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily. The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

NCT ID: NCT05155345 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus

Start date: January 11, 2022
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus erythematosus (SLE).

NCT ID: NCT05155254 Active, not recruiting - Metastatic Melanoma Clinical Trials

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

Start date: May 17, 2022
Phase: Phase 3
Study type: Interventional

Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.

NCT ID: NCT05151744 Active, not recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema

Start date: December 17, 2021
Phase: Phase 2
Study type: Interventional

Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.

NCT ID: NCT05151731 Active, not recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema

Start date: December 31, 2021
Phase: Phase 2
Study type: Interventional

Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.

NCT ID: NCT05148650 Active, not recruiting - Clinical trials for Perioperative Hemorrhage

Impact of Balanced Crystalloid and Colloid Infusion on Haemostasis in Healthy Male Volunteers

Start date: February 16, 2021
Phase: N/A
Study type: Interventional

The project focuses on perioperative bleeding that requires transfusion of blood products and supplementation of intravascular volume with crystalloids and colloids. The implemented fluid therapy affects coagulation and fibrinolysis, depending on the type of fluid used in an intravenous infusion. Massive haemorrhage significantly impacts the perioperative period and postoperative quality of life and requires individualized therapy, rending the ongoing project relevant from the perspective of the patients.