title: Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

lead_sponsor: Merck Serono S.A. - Geneva


title:
A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines

 Etude multicentrique, randomisée en double-aveugle, contrôlée par traitement actif et placebo, testant l’efficacité et la sécurité d’emploi du ligélizumab (QGE031) chez des adultes et des adolescents souffrant d’urticaire chronique spontanée non contrôlée par un traitement antihistaminique anti-H1

source: euctr

lead_sponsor: Novartis Pharma AG

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title:
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia

 Étude de phase 3 randomisée, multicentrique, en ouvert portant sur l’acalabrutinib (ACP-196) comparé au choix de traitement de l’investigateur, soit idélalisib plus rituximab ou bendamustine plus rituximab, chez des sujets atteints de leucémie lymphoïde chronique en rechute ou réfractaire

lead_sponsor: Acerta Pharma BV

status: Ongoing

status_simplified: Ongoing


title: A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis

acronym: GEMINI 2

lead_sponsor: Genzyme Corporation


title:
An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

 Étude internationale de phase 3 randomisée, en ouvert, multicentrique, portant sur BLU-285 comparé au régorafénib chez des patients atteints d’une tumeur stromale gastro-intestinale (GIST) localement avancée, non résécable ou métastatique

lead_sponsor: Blueprint Medicines Corporation


title: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension to studies ID-078A301 and ID-078A302 to assess the long term safety and tolerability of ACT-541468 in adult and elderly subjects with insomnia disorder

lead_sponsor: Idorsia Pharmaceuticals Ltd


title: An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)

acronym: IMBRELLA B

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)


title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors

lead_sponsor: Novo Nordisk A/S


title: A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

lead_sponsor: MediWound Ltd.

status_simplified: Unknown


title:
A Multicenter, Double-blind, Randomized Withdrawal extension study of subcutaneous secukinumab to demonstrate long-term efficacy, safety and tolerability in subjects with moderate to severe hidradenitis suppurativa

 Etude d’extension multicentrique, en double-aveugle, randomisée, de retrait du traitement, évaluant l’efficacité, la sécurité d’emploi et la tolérance à long terme du secukinumab administré en sous-cutané chez des patients présentant une hidradénite suppurée modérée à sévère


title: A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced  Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

acronym: Pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select,  Advanced Gastric  or GEJ Adenocarcinoma

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,


title: Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease

acronym: FLOW


title: A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency


title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

lead_sponsor: Arena Pharmaceuticals Inc.


title:
A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Previously Untreated Multiple Myeloma who are Eligible for High-dose Therapy

 Étude de phase 3 comparant l’association de daratumumab, VELCADE (bortézomib), lénalidomide et dexaméthasone (D-VRd) par rapport au traitement par VELCADE (bortézomib), lénalidomide et dexaméthasone (VRd) chez des patients présentant un myélome multiple non traités auparavant mais éligibles à un traitement à fortes doses

acronym:
The Perseus trial

 Etude Perseus

lead_sponsor: European Myeloma Network (EMN)


title: A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)

lead_sponsor: Amgen Inc


title:
A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa

 Etude multicentrique, randomisée en double aveugle, évaluant
 l'efficacité à court terme (16 semaines) et à long terme (jusqu’à 1 an), la sécurité d’emploi et la tolérance de 2 schémas osologiques souscutanés de secukinumab chez des patients adultes présentant une hidradénite suppurée modérée à sévère (SUNRISE)

acronym: SUNRISE


title: A Phase 3 Randomized Study of Cystectomy plus Perioperative Pembrolizumab versus Cystectomy Alone in Cisplatin-ineligible Participants with Muscleinvasive Bladder Cancer (KEYNOTE-905)

acronym: A Phase 3 trial of perioperative pembrolizumab for cisplatin-ineligible patients with MIBC

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title:
RAINBOW extension study: an extension study to evaluate the long term efficacy and safety of RAnibizumab compared with laser therapy for the treatment of INfants BOrn prematurely With retinopathy of prematurity

 Extension de l’étude RAINBOW: Une étude d’extension pour comparer l’efficacité et la tolérance à long terme du ranibizumab à celles du traitement par laser chez les nourrissons prématurés atteints de rétinopathie du prématuré (ROP)

acronym:
RAINBOW Extension study

 Extension de l’étude RAINBOW

lead_sponsor: Novartis Pharma Services AG


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

lead_sponsor: Exelixis, Inc.


title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

lead_sponsor: Celgene Corporation


title:
A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS

 Une étude en deux parties de ZX008 chez les enfants et les adultes souffrant du syndrome de Lennox-Gastaut (SLG): Partie 1: Essai randomisé, en double aveugle, contrôlé versus placebo de deux doses fixes de ZX008 (chlorhydrate de fenfluramine) en solution orale comme traitement d’appoint contre les crises épileptiques chez des enfants et des adultes souffrant de SLG; suivi de la Partie 2: Une étude d’extension en ouvert pour évaluer la sécurité à long terme de ZX008 chez les enfants et les adultes souffrant de SLG

lead_sponsor: Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.


title: Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults

acronym: DisCoVeRy

lead_sponsor: INSERM

lead_sponsor_type: academique


title:
ENVISION: A Phase 3 Randomized, Double-blind, Placebo-controlled Multicenter Study with an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients with Acute Hepatic Porphyrias

 ENVISION : Étude multicentrique de phase III randomisée, en double aveugle, contrôlée par placebo, avec extension en ouvert, évaluant l’efficacité et la sécurité du givosiran chez des patients atteints d’une porphyrie hépatique aiguë

acronym: ENVISION

lead_sponsor: Alnylam Pharmaceuticals, Inc.


title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) AS MAINTENANCE THERAPY FOR PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA FOLLOWING SECOND-LINE THERAPY  (THE CONTINUUM TRIAL)

acronym: The Continuum trial


title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

 Étude de phase 3, randomisée, en double aveugle, contrôlée contre placebo, multicentrique, évaluant le traitement d'entretien par niraparib chez des patientes atteintes d’un cancer de l'ovaire avancé avec défaut de recombinaison homologue (HRD-positif) en réponse à une chimiothérapie de première ligne à base de platine

lead_sponsor: TESARO, Inc.


title:
A phase 3  multi-center, long-term extension study investigating the efficacy and safety of  PF-04965842, with or without topical medications, administered to subjects aged 12 years and older with moderate to severe atopic dermatitis

 Étude d’extension à long terme, multicentrique, de phase III, évaluant l’efficacité et la tolérance du PF-04965842, avec ou sans médicaments topiques, administrés à des sujets âgés de 12 ans et plus, atteints de dermatites atopiques modérées à graves

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title:
A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related Genes (including BRCA1/2) (VIOLETTE)

 Étude de phase II, ouverte, randomisée, multicentrique visant à évaluer la sécurité d'emploi et l'efficacité d'agents ciblant la réparation des dommages à l'ADN en combinaison avec l'olaparib par rapport à l'olaparib en monothérapie dans le traitement de patientes atteintes de cancer du sein triple négatif métastatique stratifiées en fonction des altérations des gènes impliqués dans la réparation par recombinaison homologue (HRR) (y compris BRCA1/2) (étude VIOLETTE)

lead_sponsor: AstraZeneca AB


title:
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD)

 Elacestrant en monothérapie contre traitement standard du cancer du sein métastatique RO+ HER2- après traitement préalable par inhibiteur de CDK4/6: une étude de phase 3, randomisée, ouverte, contrôlée et multicentrique (EMERALD)

acronym: EMERALD

lead_sponsor: Radius Pharmaceuticals Inc.


title:
A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab

 Étude de phase 3, multicentrique, en ouvert, randomisée, en groupes parallèles, portant sur la pharmacocinétique et la non-infériorité du ravulizumab administré par voie sous-cutanée comparé à une administration par voie intraveineuse chez des patients adultes atteints d’hémoglobinurie paroxystique nocturne actuellement traités par éculizumab.

acronym: Étude de non-infériorité PK portant sur le ravulizumab SC comparé au ravulizumab IV.

lead_sponsor: Alexion Pharmaceuticals, Inc.


title: OPEN-LABEL, SINGLE-ARM, MULTICENTER, LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN PEDIATRIC SUBJECTS WITH EPILEPSY

lead_sponsor: UCB Pharma SA


title: A phase III randomized, double-blind study of induction(daunorubicin/cytarabine) and consolidation (high dose cytarabine) chemotherapy + midostaurin (PKC412) (IND # 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML)


title:
A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS)

 Etude multicentrique de 48 semaines, menée en double-aveugle sur 6 groupes, randomisée et contrôlée par placebo, destinée à évaluer la sécurité d’emploi et l’efficacité de plusieurs doses de CFZ533 par voie sous-cutanée, dans deux populations distinctes de patients atteints du syndrome de Sjögren (TWINSS)

acronym: TWINSS

lead_sponsor: Novartis Pharma AG


title: Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ? 2 to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis.

lead_sponsor: Amgen Inc.


title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

lead_sponsor: MedImmune, LLC


title:
Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) - DHELIVER

 Étude multicentrique et randomisée de phase IIB, contrôlée par placebo et en double aveugle, visant à évaluer l’efficacité et la sécurité du dispositif HepaStem chez les patients atteints d’une insuffisance hépatique aiguë sur maladie chronique du foie (ACLF) - DHELIVER

acronym: HEP102 - DHELIVER

lead_sponsor: Promethera Biosciences


title:
A 24-week multi-center, double-blind, placebo controlled dose range finding study to investigate the efficacy and safety of oral QBW251 in COPD patients on triple inhaled therapy (LABA/LAMA/ICS)

 Etude multicentrique de recherche de dose, en double aveugle contrôlée contre placebo, d’une durée de 24 semaines, destinée à évaluer l'efficacité et la sécurité d’emploi du QBW251 administré par voie orale chez des patients atteints de BPCO sous trithérapie inhalée (LABA/LAMA/CSI)


title: A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft versus host disease after allogenic stem cell transplantation

acronym: REACH 3


title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

lead_sponsor: Galderma S.A.


title: A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)


title:
A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-HER2 Therapies and Require Systemic Treatment.

 Étude randomisée de phase III comparant le margetuximab plus chimiothérapie au trastuzumab plus chimiothérapie dans le traitement de patients atteints de cancer du sein métastatique HER2+ ayant reçu deux traitements anti-HER2 précédents et nécessitant un traitement systémique

lead_sponsor: MacroGenics, Inc.


title: A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis

lead_sponsor: Intercept Pharmaceuticals Inc.


title: European Low and Intermediate Risk Neuroblastoma

acronym: LINES

lead_sponsor: INSTITUTO DE INVESTIGACION SANITARIA LA FE DE VALENCIA


title:
A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome

 Étude randomisée, en double aveugle, contrôlée contre placebo, multicentrique, de recherche de dose de phase 2 visant à évaluer la sécurité d'emploi et l'efficacité de doses multiples de VAY736 administrées par voie sous-cutanée chez des patients présentant un Syndrome de Sjögren primitif modéré à sévère


title:
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric
 Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia In First or Second Relapse

lead_sponsor: Sanofi-aventis recherche & developpement


title:
A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) antibody-radionuclide-conjugate for treatment of relapsed non-Hodgkin lymphoma.

 Étude de phase I/II portant sur le radio-immunoconjugué lilotomab satetraxetan marqué au lutétium (177Lu) (Betalutin®) pour le traitement d'un lymphome non hodgkinien récidivant

lead_sponsor: Nordic Nanovector ASA


title:
A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MeRmaiD-1)

 Étude multicentrique de phase III, randomisée, en double aveugle, contrôlée versus placebo, évaluant l’efficacité du durvalumab en traitement adjuvant associé à une chimiothérapie à base de platine chez des patients présentant un cancer du poumon non à petites cellules (CPNPC) de stade II-III complètement réséqué (MeRmaiD-1)


title: Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia Coronavirus COVID-19 (REMAP-CAP-COVID-19)

acronym: REMAP-CAP

lead_sponsor: University Medical Center Utrecht


title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Low-dose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title:
Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

 Étude de phase III randomisée, contre placebo, en double aveugle comparant des gélules d'acide nor-ursodésoxycholique au placebo dans le traitement de la cholangite sclérosante primitive

lead_sponsor: Dr. Falk Pharma GmbH


title: A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)

acronym: PERSEUS

lead_sponsor: Genzyme Corporation


title:
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E MUTANT COLORECTAL CANCER

 ÉTUDE OUVERTE DE PHASE 3, MULTICENTRIQUE, RANDOMISÉE DE LA COMBINAISON ENCORAFÉNIB ET CÉTUXIMAB COMME TRAITEMENT DE
 PREMIÈRE INTENTION, AVEC OU SANS CHIMIOTHÉRAPIE, COMPARÉE AU TRAITEMENT STANDARD, AVEC UNE PHASE PRELIMINAIRE DE SECURITE POUR L’ASSOCIATION AVEC LA CHIMIOTHERAPIE CHEZ LES PATIENTS PRESENTANT UN CANCER COLORECTAL MÉTASTATIQUE AVEC
 MUTATION BRAF V600E

acronym: The BREAKWATER Study

lead_sponsor: Pfizer Inc.

status: Not Authorised


title: A Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in subjects with hereditary angioedema

lead_sponsor: BioCryst Pharmaceuticals Inc.


title:
A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer
 patients

lead_sponsor: TESARO Inc.


title: An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310

lead_sponsor: United Therapeutics Corporation


title: Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.

acronym: In-SIGHT study

lead_sponsor: Laboratoires THEA


title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

lead_sponsor: Millennium Pharmaceuticals, Inc.


title:
A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator’s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation

 Étude de phase 3 randomisée, multicentrique, en ouvert, comparant l'efficacité et la tolérance de l'Acalabrutinib (ACP-196) associé au Venetoclax avec et sans Obinutuzumab, versus une chimio-immunothérapie au choix de l'investigateur chez des patients atteints d’une leucémie lymphoïde chronique naïfs de traitement, sans délétion 17p ni mutation TP53.

acronym: Not available at this time

lead_sponsor: Acerta Pharma B.V.


title:
A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib

 Étude randomisée menée en ouvert comparant le ponatinib au nilotinib chez des patients atteints de leucémie myéloïde chronique en phase chronique suite à une résistance à l'imatinib

acronym: OPTIC 2L

lead_sponsor: ARIAD Pharmaceuticals, Inc.


title:
A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis

 Étude multicentrique, randomisée, partiellement en aveugle et contrôlée contre traitement actif, du sécukinumab, destinée à démontrer la réduction de la progression radiographique versus GP2017 (biosimilaire adalimumab) à 104 semaines et évaluer à long terme la sécurité d'emploi, la tolérance et l'efficacité jusqu'à 2 ans, chez les patients atteints d'une spondylarthrite ankylosante active

acronym: SURPASS

lead_sponsor: Novartis Pharma AG


title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
 (CheckMate 7FL: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 7FL)

acronym: Nivo/Placebo with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in ER+/HER2-Breast Cancer

lead_sponsor: Bristol-Myers Squibb International Corporation


title:
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 compared with mepolizumab or benralizumab

 Étude de 52 semaines de non-infériorité, randomisée, en double aveugle, avec double placebo, en groupes parallèles, multicentrique, évaluant le taux d’exacerbation, le contrôle de l’asthme et la sécurité d’emploi chez des patients adultes et adolescents atteints d’asthme sévère présentant un phénotype éosinophilique et traités par GSK3511294, par rapport au traitement par mépolizumab ou benralizumab

lead_sponsor: GlaxoSmithKline Research & Development Limited


title:
A Phase 3, 182-week, Open-Label, Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic Failure

 Etude ouverte de phase 3 sur 182 semaines, portant sur la tolérabilité et la sécurité du TD-9855 dans le traitement de l’hypotension orthostatique symptomatique neurogène (HOsn) chez des patients présentant une dysautonomie primaire.

lead_sponsor: Theravance Biopharma Ireland Limited


title: A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients With Duchenne Muscular Dystrophy

lead_sponsor: Sarepta Therapeutics, Inc.


title:
A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021

 Etude randomisée, à 3 bras de traitement, en double aveugle, de non-infériorité, d’une durée de 2 ans, comparant l’efficacité et la sécurité d’emploi de l’ofatumumab et du siponimod versus fingolimod chez des patients pédiatriques atteints de sclérose en plaques, suivie d’une extension en ouvert.

acronym: NEOS


title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors

lead_sponsor: Novo Nordisk A/S


title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled with Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin

acronym: SWITCH

lead_sponsor: Merck Sharp & Dohme Corp.


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

status: Prematurely Ended


title: A 52-week open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimer's disease (REFLECT-4).

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Mono- or Dual Combination Oral Antihyperglycemic Therapy

acronym: TECOS

lead_sponsor: Merck & Co., Inc.


title:
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES: A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER CLINICAL STUDY

 — OPEN-LABEL ESL EXTENSION —

acronym: not applicable

lead_sponsor: BIAL - Portela & Ca, S.A.


title: A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral Intertrochanteric Fracture of the Proximal Femur, Status Post Fixation with a Sliding Hip Screw or Intramedullary Nail

lead_sponsor: Amgen Inc


title: An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).

acronym: GO-MORE

lead_sponsor: Schering-Plough Research Institute, A Division of Schering Corporation


title: A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis

lead_sponsor: Novartis Pharma Services AG


title: A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease

acronym: A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease

lead_sponsor: Celgene Corporation


title: An Open, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis

lead_sponsor: Amgen Inc.


title: A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy

acronym: METEOR

lead_sponsor: Exelixis, Inc.


title: A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.

lead_sponsor: Abbott GmbH & Co. KG (Abbott)


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome

lead_sponsor: Takeda Global Research & Development Centre (Europe) Ltd.


title: Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomised, double-blind, double-dummy, parallel group, one-year study).

acronym: POET

lead_sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG


title: AN EXPLORATORY TRIAL TO ASSESS NATURALISTIC SAFETY AND EFFICACY OUTCOMES IN PATIENTS TRANSITIONED TO USTEKINUMAB FROM PREVIOUS METHOTREXATE THERAPY (TRANSIT)

acronym: TRANSIT

lead_sponsor: Janssen-Cilag International NV


title: A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 μg o.d. vs inhaled tiotropium 18 μg o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD

acronym: INVIGORATE


title: A Pan-European randomized, parallel group, two-arm placebo-controlled, double-blind multicenter study of Rimonabant 20mg once daily in the treatment of abdominally obese patients with impaired fasting blood glucose with or without other comorbidities

lead_sponsor: sanofi aventis groupe


title:
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects with a Recent Acute Coronary Syndrome
 The ATLAS ACS 2 TIMI 51 Trial (The second trial of Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome)
 Amendment INT-1

acronym: The ATLAS ACS 2 TIMI 51 Trial

lead_sponsor: Janssen-Cilag International N.V.