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Phase III

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A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)
Published:

EudraCT Number: 2017-001820-22
Sponsor Protocol Number: Sci-B-Vac–002
Sponsor Name: VBI Vaccines INC.
Start Date: 2018-02-20
Medical condition: Hepatitis B Vaccination
Disease:
Version: 20.0
SOC Term: 100000004865
Classification Code: 10054181
Term: Hepatitis B immunization
Level: LLT

Population Age: Adults
Gender: Male, Female
Trial Protocol: GB (Completed), DE (Completed), FI (Completed), BE (Completed)

A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Sti...
Published:

EudraCT Number: 2015-002874-19
Sponsor Protocol Number: 63935937MDS3001
Sponsor Name: Janssen-Cilag International NV
Start Date: 2015-11-23
Medical condition: Myelodysplastic syndrome (MDS)
Disease:
Version: 18.0
SOC Term: 100000004851
Classification Code: 10028536
Term: Myelodysplastic syndromes
Level: HLT

Population Age: Adults, Elderly
Gender: Male, Female
Trial Protocol: FR (Ongoing), BE (Ongoing), ES (Ongoing), DE (Ongoing), GB (Ongoing), NL (Ongoing)

Open label extension study to evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in previous dupilumab asthma clinical study
Published:

EudraCT Number: 2013-003856-19
Sponsor Protocol Number: LTS12551
Sponsor Name: Sanofi-aventis recherche et développement
Start Date: 2014-05-28
Medical condition: Asthma
Disease:
Version: 16.1
SOC Term: 10038738 - Respiratory, thoracic and mediastinal disorders
Classification Code: 10003553
Term: Asthma
Level: PT

Population Age: Adults, Elderly
Gender: Male, Female
Trial Protocol: ES (Completed), IT (Ongoing), PL (Ongoing), DE (Completed), GB (Completed), NL (Completed), HU (Completed), BE (Completed), DK (Completed), SE (Completed), Outside EU/EEA

Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Prostate Cancer
Intervention:   Drug: rhPSMA-7.3 (18F) Injection
Sponsors:   Blue Earth Diagnostics;   Parexel
Not yet recruiting

A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Patients With Metastatic Colorectal Cancer
Interventions:   Drug: Fluoropyrimidine;   Drug: Bevacizumab
Sponsor:   Centre Hospitalier Universitaire Dijon
Not yet recruiting

Multicenter Randomized Study on the Efficacy of Intravenous Iron Injection in Cancer Patients With Anemia
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Cancer Anaemia
Intervention:   Drug: Ferinject
Sponsor:   Samsung Medical Center
Recruiting

A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Alzheimer's Disease
Interventions:   Drug: Tricaprilin;   Drug: Placebo
Sponsor:   Cerecin
Not yet recruiting

Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Prostate Cancer
Intervention:   Drug: rhPSMA-7.3 (18F) Injection
Sponsors:   Blue Earth Diagnostics;   Parexel
Not yet recruiting

Effect of Probiotic Use Bifidobacterium Animalis Subsp. Lactis in Peri-implant Mucositis
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Mucositis Oral
Interventions:   Other: Mechanical debridements;   Biological: Bifidobacterium animalis subsp. lactis
Sponsor:   University of Sao Paulo
Completed

Revance Announces Publication of Pooled Results from Phase 3 Trials for Glabellar Lines in the Journal of the American Academy of Dermatology
Published: 5 Dec 2019 | 0:00 UTC

Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company pioneering new innovations in neuromodulator products for aesthetic and therapeutic indications, today announced the publication of the pooled data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (SAKURA 1 and SAKURA 2) evaluating Revance’s long-acting neuromodulator product, DaxibotulinumtoxinA

Sage Therapeutics Reports Topline Results from Pivotal Phase 3 MOUNTAIN Study of SAGE-217 in Major Depressive Disorder
Published: 5 Dec 2019 | 0:00 UTC

Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD).

Sage's MDD Treatment Fails to Distinguish Itself from Placebo in Late-Stage Trial
Published: 5 Dec 2019 | 0:00 UTC

The Phase III failure was certainly a setback for the company as it chased Janssen and its Esketamine-based treatment Spravato for MDD.

Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness
Published: 3 Dec 2019 | 17:00 UTC

Condition:   Motion Sickness
Interventions:   Drug: DPI-386 Nasal Gel;   Drug: Placebos
Sponsor:   Repurposed Therapeutics, Inc.
Completed

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable
Published: 3 Dec 2019 | 17:00 UTC

Condition:   Neurodermatitis
Interventions:   Drug: Dupilumab SAR231893;   Drug: Placebo;   Drug: Moisturizers;   Drug: Low to medium potent topical corticosteroids;   Drug: Topical calcineurin inhibitors
Sponsors:   Sanofi;   Regeneron Pharmaceuticals
Not yet recruiting

Trial to Compare the Efficacy and Safety of F-627 and GRAN®
Published: 22 Nov 2019 | 17:00 UTC

Condition:   Breast Cancer
Intervention:   Biological: F-627
Sponsor:   Generon (Shanghai) Corporation Ltd.
Completed

Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly
Published: 25 Oct 2019 | 16:00 UTC

Condition:   Clinically Symptomatic Respiratory Illness
Interventions:   Drug: Dactolisib;   Drug: Placebo
Sponsor:   Restorbio Inc.
Withdrawn

Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly
Published: 25 Oct 2019 | 16:00 UTC

Condition:   Clinically Symptomatic Respiratory Illness
Interventions:   Drug: Dactolisib;   Drug: Placebo
Sponsor:   Restorbio Inc.
Withdrawn

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
Published: 25 Feb 2019 | 17:00 UTC

Condition:   Depressive Disorder, Treatment-Resistant
Interventions:   Drug: Esketamine 28 mg;   Drug: Esketamine 56 mg;   Drug: Esketamine 84 mg;   Drug: Placebo;   Drug: Escitalopram;   Drug: Sertraline;   Drug: Duloxetine;   Drug: Mirtazapine;   Drug: Agomelatine;   Drug: Bupropion;   Drug: Trazodone Prolonged Release
Sponsor:   Janssen-Cilag International NV
Withdrawn

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression
Published: 25 Feb 2019 | 17:00 UTC

Condition:   Depressive Disorder, Treatment-Resistant
Interventions:   Drug: Esketamine 28 mg;   Drug: Esketamine 56 mg;   Drug: Esketamine 84 mg;   Drug: Placebo;   Drug: Escitalopram;   Drug: Sertraline;   Drug: Duloxetine;   Drug: Mirtazapine;   Drug: Agomelatine;   Drug: Bupropion;   Drug: Trazodone Prolonged Release
Sponsor:   Janssen-Cilag International NV
Withdrawn

A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
Published: 21 Jan 2019 | 17:00 UTC

Conditions:   Advanced Breast Cancer;   HER2-positive Breast Cancer
Interventions:   Drug: Trastuzumab;   Drug: Pertuzumab;   Drug: Vinorelbine;   Drug: Docetaxel
Sponsors:   iOMEDICO AG;   Arbeitsgemeinschaft fur Internistische Onkologie;   Amgen
Withdrawn

A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer
Published: 21 Jan 2019 | 17:00 UTC

Conditions:   Advanced Breast Cancer;   HER2-positive Breast Cancer
Interventions:   Drug: Trastuzumab;   Drug: Pertuzumab;   Drug: Vinorelbine;   Drug: Docetaxel
Sponsors:   iOMEDICO AG;   Arbeitsgemeinschaft fur Internistische Onkologie;   Amgen
Withdrawn

This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms
Published: 28 Feb 2018 | 17:00 UTC

Condition:   Heart Failure
Interventions:   Drug: Empagliflozin;   Drug: Placebo
Sponsors:   Boehringer Ingelheim;   Eli Lilly and Company
Completed

Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
Published: 21 Nov 2017 | 17:00 UTC

Condition:   Squamous Cell Carcinoma of the Head and Neck
Interventions:   Biological: Nivolumab;   Drug: Cetuximab;   Drug: Cisplatin;   Radiation: Radiotherapy
Sponsors:   Bristol-Myers Squibb;   Ono Pharmaceutical Co. Ltd
Completed

Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
Published: 17 Nov 2017 | 17:00 UTC

Condition:   Dermatitis, Atopic
Interventions:   Drug: Dupilumab;   Drug: Matching Placebo;   Other: Background Treatment: Topical Corticosteroids;   Other: Background Treatment: Moisturizers
Sponsors:   Regeneron Pharmaceuticals;   Sanofi
Completed



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