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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate
the Efficacy and Safety of AMG 334 in Migraine Prevention

To evaluate the effect of AMG 334 compared to placebo on the change from baseline in mean monthly migraine days, in subjects with episodic migraine.hypothesis: In subjects with episodic migraine, AMG 334 has a greater reduction from baseline in mean…

A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double
Dummy Extension Study of Preladenant in Subjects With Moderate
to Severe Parkinson*s Disease

This is a active-controlled dose-range-finding study which is also designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twice daily during long term use as an adjunct therapy to L-dopa when administered to subjects with moderate to…

Protocol I2R-MC-BIAO;
The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: a Double-Blind, Randomized, 52 Week Study ;The IMAGINE 3 Study;

The primary objective is to demonstrate that glycemic control, as measured by hemoglobin A1c(HbA1c) at 52 weeks for LY2605541 is noninferior to insulin glargine, when each is combined with preprandial insulin lispro, in patients with type 1 diabetes…

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib

The primary objective of this phase III study in subjects with metastatic and/or unresectable GIST who have progressed after therapy with at least imatinib and sunitinib is to compare the treatment groups in terms of Progression-Free Survival (PFS…

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects with Locally Advanced or Metastatic, Non-Squamous, Non*Small-Cell Lung Cancer (NSCLC)

The primary objective of this study is to evaluate overall survival (OS) in the intent-to-treat (ITT) subject population defined by this protocol.Key secondary objectives are to evaluate OS in the epidermal growth factor receptor (EGFR) wild type…

A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

The primary objective of this study is to compare overall survival (OS) in patients with metastatic colorectal carcinoma (CRC) when treated with FOLFIRI in combination with placebo versus FOLFIRI in combination with ramucirumab DP.Secondary…

A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled, Double Dummy
Efficacy and Safety Study of Preladenant in Subjects with Moderate
to Severe Parkinson*s Disease.

This is a placebo- and active-controlled dose-range-finding study which isalso designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twicedaily versus placebo as an adjunct therapy to L-dopa when administered to subjectswith moderate…

A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn*s disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study.

To evaluate the efficacy and safety of eASCs compared to placebo for the treatment of complex fistulas in Crohn*s disease over a 24- and 104-week period.

A phase 3 prospective, multicenter study to evaluate efficacy and safety of rVWF with or without ADVATE in elective surgical procedures in subjects with severe von Willebrand disease

The primary objective of this study is to assess the hemostatic efficacy and safety of rVWF with or without ADVATE in subjects (* 18 years) diagnosed with hereditary severe VWD undergoing major and minor elective surgical procedures.

A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy

Primary objective:To demonstrate that tralokinumab in combination with TCS is superior to placebo in combination with TCS in treating moderate-to-severe AD.Secondary objectives:To evaluate the efficacy of tralokinumab in combination with TCS on…

A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS-986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Postive Gastric or Gastroesophageal Junction Adenocarcinoma

Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…

A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC 1002 in Patients with Hyperlipidemia at High Cardiovascular Risk Who are not Adequately Controlled by Their Lipid-Modifying Therapy

Primary Safety:* To evaluate the long-term safety and tolerability of ETC 1002 versus placebo in high cardiovascular (CV) risk patients with hyperlipidemia (with underlying heterozygous familial hypercholesterolemia [HeFH] and/or atherosclerotic…

A phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer

To compare invasive disease-free survival (iDFS) for ribociclib + ET versus placebo + ET in patients with HR-positive, HER2-negative, EBCwith high risk of recurrence.

A randomised, double-blind, placebo-controlled, parallel-group, multi-centre trial to evaluate the efficacy, safety, and tolerability of tralokinumab monotherapy in adolescent subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

Primary objectiveTo evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.Secondary objectivesTo evaluate the efficacy…

Randomized multicenter, phase III trial evaluating the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (* 65 years) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen (CABASTY).

To evaluate the incidence of grade * 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in…

A Phase 3, INterVentional, Double-Blind, Placebo Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients with AdvanCed Gastrointestinal Stromal TUmorS who have Received Treatment with Prior Anticancer Therapies

Primary Objectives:• To assess the efficacy (progression free survival [PFS]) of DCC 2618 by independent radiologic review in patients with advanced gastrointestinal stromal tumors (GIST) who have received prior therapiesKey Secondary Objectives:•…

A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)

To assess the safety and efficacy of DBV712 in initiating desensitisation of peanut in children aged 1 to 3 years with peanut allergy, after 12 months of treatment with Epicutaneous Immunotherapy EPIT).

A Randomized Phase 3 Study of Adagrasib in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy

This study has been transitioned to CTIS with ID 2023-506241-30-00 check the CTIS register for the current data. Primary objectives:To compare the efficacy of Adagrasib in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6)…

A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.

Primary Objectives1) To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) in first line recurrent / metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects, treated…

A randomized, open-label, parallel-group, 18-month Phase 3 study to evaluate the effect of venglustat compared with usual standard of care on left ventricular mass index in participants with Fabry disease and left ventricular hypertrophy

This study has been transitioned to CTIS with ID 2023-509715-91-00 check the CTIS register for the current data. Primary:•To compare the effect of venglustat with standard of care Fabry therapies on left ventricular mass index over 18 months in…