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A double-blind, randomised, placebo-controlled, Phase II study to evaluate ProCervix efficacy to clear HPV 16 and HPV 18 infection in women with normal cytology or ASCUS/LSIL

Primary Objective To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo adjuvanted with imiquimod, to induce HPV 16 and 18 viral clearance at 12 months in HPV 16 and/or 18 infected women using a type specific,…

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician*s Choice for Metastatic Triple Negative Breast Cancer (mTNBC) * (KEYNOTE-119)

The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician*s choice (which includes Capecitabine, Eribulin, Gemcitabine…

A phase I dose escalation study of intravesical TMX-101 in subjects with Non-Muscle-Invasive Bladder Cancer

The primary objectives are the following:- To assess the safety profile and determine the Optimal Biological Dose (OBD) or Maximum Tolerated Dose (MTD), whichever occurs first, of intravesically administered TMX-101. The secondary objectives are the…

The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician*s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine

Primary Objectives:* To compare overall survival (OS) of patients who receive NKTR-102given once every 21 days (q21d) to patients who receive Treatment ofPhysician*s Choice (TPC) selected from the following list of seven singleagentintravenous…

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)

This study has been transitioned to CTIS with ID 2022-503050-39-00 check the CTIS register for the current data. To evaluate the effect of benralizumab 100 mg on COPD exacerbations in patients with moderate to very severe COPD.

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

The objective of this Phase 3 study is to investigate the safety and efficacy of benralizumab as a treatment for patients with eosinophilic gastritis and/or gastro-enteritis.

A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator*s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Dual Primary objective: - To demonstrate the superiority of Dato-DXd compared to ICC by assessment of PFS in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer, who have been treated with 1 or 2 lines of chemotherapy…

*Differences in effect of treatment with mepolizumab and benralizumab on resident and inflammatory eosinophils.

To test the hypothesis: the mode of action of benralizumab being ADCC will target both resident and inflammatory eosinophils whereas mepolizumab only targets inflammatory eosinophils. This will achieved by a head-to-head comparison of the presence…

5-AMINOLEVULINIC ACID PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PREMALIGNANT DISORDERS OF THE VULVA

Primary objective: To assess the efficacy of low dose rate light fractionated aminolevulinic acid-Photodynamic Therapy (ALA-PDT) for treatment of VLS and HSIL. Clinical and histological response. Secondary objectives: Tolerence of ALA-PDT by…

A 52-week, randomised, double-blind, double-dummy, parallel group,multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 (depemokimab) compared with mepolizumab or benralizumab

This study has been transitioned to CTIS with ID 2023-510230-84-00 check the CTIS register for the current data. To evaluate the efficacy of GSK3511294 100 mg (SC) every 26 weeks versus maintaining existing treatment with either mepolizumabor…

*Differences in effect of treatment with mepolizumab and benralizumab on resident and inflammatory eosinophils"

To test the hypothesis: the mode of action of benralizumab being ADCC will target both resident and inflammatoryeosinophils whereas mepolizumab only targets inflammatory eosinophils. This will achieved by a head-to-headcomparison of the presence of…

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA)

The objective of this Phase 3 study is to investigate the safety and efficacy of benralizumab as a treatment for patients with eosinophilic esophagitis.