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Randomized placebo-controlled trial to investigate clinical efficacy, anti-inflammatory properties and
safety of prednisolone in hand osteoarthritis: a proof-of-concept study

Primary Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.Secondary Objectives: The secondary…

A multicenter, open-label (Part A) followed by a randomized, double-blind, parallel-group, placebo controlled study (Part B) to evaluate maintenance of remission in subjects with active axial spondyloarthritis (axSpA) receiving either Certolizumab pegol 200mg Q2W or 200mg Q4W as compared to placebo

The primary objective of the study is to evaluate the percentage of subjects who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W (half-dose) during Part B. The secondary objectives are: 1) to evaluate the percentage of subjects…

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and
Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or
Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in…

A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…

A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with Cystic Fibrosis-Related Diabetes

Investigate the effect of adjuvant metformin therapy on insulin need and on glycaemic control in CFRD patients.

A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in;Subjects with Moderate to Severe Hidradenitis Suppurativa

The primary objective of this study is to determine the clinical safety and efficacy of adalimumab compared to placebo in subjects with moderate to severe HS after 12 weeks of treatment. A secondary objective is to evaluate safety and explore…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in
Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-…

Randomized double blind multi-centre study of the effects on low-dose pegvisomant treatment in acromegalic subjects in whom the IGF1 levels has been normalized by long-acting somatostatin analogues

Primary Study Objective:To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the…

Multicenter, double-blind, placebo-controlled, randomized, prospective study of bosentan as adjunctive therapy to inhaled nitric oxide in the management of persistent pulmonary hypertension of the newborn (PPHN)

To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…

A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Inactive Non-infectious Intermediate-, Posterior-, or Pan-uveitis

The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo in subjects with inactive non-…

Once-daily oral direct factor Xa rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension study.

The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…

A Three Arm Double blind, Randomised, Multicenter Study to investigate the Non-Inferiority of a Soft Gel Capsule of Ibuprofen Lipid Formulation (total daily dose 1200 mg) versus a standard Soft Gel Ibuprofen capsule (total daily dose 1200 mg and 2400 mg) in the Treatment of Patients with Episodic Knee Arthralgia/Flaring Knee Pain.

The principal aims of the study are to assess: 1. The effectiveness of a 5 day treatment course in arresting/ resolving episodic knee arthralgia/ flaring knee pain.2. The relative effectiveness of a low dose (1200 mg/day) of lipid formulated…

A Randomized, Double-Blind, Placebo- and Active-Controlled Study of
DS-5565 in Subjects with Pain Associated with Fibromyalgia.

The primary objective is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best…

PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (THE PALISADE STUDY)

The primary objective is to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children (ages 4-17 years, inclusive…

A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)

Patients with hyperlipidemie and an elevated Lp(a) will be asked to partipate in this study. This part potentially increases the risk of cardiovascular diseases. One of the reasons why Lp(a) is expected to increases this risk is that Lp(a)…

A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III)Who Have Not Progressed Following Definitive, Platinum-based,Concurrent Chemoradiation Therapy (PACIFIC)

The primary objective of this study is to assess the efficacy of MEDI4736 treatment compared with placebo in terms of overall survival (OS) and progression free survival (PFS; (per RECIST 1.1 as assessed by the investigator).

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

The objective is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severly Active Crohn's Disease Who Failed Prior Biologic Treatment

The objective is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active
Ulcerative Colitis

The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely…

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease

Primary Objective: To evaluate the effect of treatment with AMG 145, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs…