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A randomized, double-blind, placebo-controlled study to compare the immune effects of multiple doses of vitamin D3 in patients with allergic rhinitis/rhino-conjunctivitis caused by birch pollen and in healthy control subjects.

The primary objective is to evaluate whether 2.5 µg VD3 analogue (Zemplar® * Abbvie) in multiple subcutaneously administered doses induces a more favourable (read: anti-inflammatory) systemic immune modulation both in general parameters and allergen…

FAST * Food Allergy Specific ImmunoTherapy
A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish

To evaluate the efficacy and safety of a SCIT-treatment with a mutant recombinant fish-parvalbumin (mCyp c1) quantified in mass units and formulated in a solution with alum, in subjects with fish-allergy.

A phase IIb, Double Blind, Randomized, placebo- controlled, Double-Dummy, Dose Rangining Study To Evaluate the Clinical Efficacy and Safety of Induction and Maintenance therapy with BMS- 945429 in subjects with Moderate to Severe Crohn's Disease.

Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…

Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients

MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group
Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of
Subjects with Moderate to Severely Active Crohn*s Disease

To evaluate the safety and efficacy of intravenously administered FFP104 in subjects with active Crohn*s disease following repeat doses of FFP104.

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus

The primary objective of the research is to find out if treatment with BMS-931699 can improve systemic lupus erythematosus (SLE) disease activity. This will be measured by determining the proportion of BICLA responders who achieve BILAG disease…

Long Term Observational Study Of The Safety And Efficacy Of An Active Implantable Vagal Nerve Stimulation Device In Patients With Rheumatoid Arthritis

Primary Efficacy ObjectiveThe primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the DAS28 score.Secondary Efficacy ObjectivesThe secondary efficacy objectives are to determine the long term…

A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) (BEL114055)

Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.

A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness

Primary Objective:* To evaluate the safety and tolerability of ARGX-113.Secondary Objectives:* To evaluate the clinical effect of ARGX-113 using:-Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.-Quantitative-Myasthenia Gravis score (QMG…

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors.

Primary Objective:To compare the efficacy of BMS-986142 versus placebo on a background of MTX as assessed by ACR20 and ACR70 response rates at week 12.Secondary Objectives:1) Assess additional efficacy outcomes of BMS-986142 at week 12 and over 12…

A phase II, randomized, double-blind, placebo controlled, parallel design, dose ranging, multi-center trial of four levels of exposure of QGE031 s.c. for 16 weeks in subjects aged 18-50 years with peanut allergy (CQGE031A2208)

Primary: To characterize the QGE031 dose response relationship for the increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment.Secondary (only key parameters): The percentage of patients…

A randomized, double-blind, placebo-controlled, parallel group study evaluating efficacy and safety of QAW039 in the treatment of patients with moderate to severe atopic dermatitis (CQAW039X2201)

Primary objective: To evaluate the efficacy of once daily doses of QAW039, as measured by EASI after 12 weeks of treatment, relative to placebo, in adult patients with moderate to severe AD. To evaluate safety and tolerability.Secondary objectives:…

Ephedrine as add-on therapy for patients with myasthenia gravis

The main objective of this pilot study of n-of-one trials is to determine the effect of add-on treatment with ephedrine for all participants enrolled in this small series of n-of-one trials. Secondary objectives include determining the effect in…

Mesenchymal stromal cells for treatment of drug resistant pediatric Juvenile idiopathic arthritis

To find out if intravenous MSC is a safe treatment for children with therapy-resistant JIA

RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS

The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for therapy resistant progressive IMID- IP patients. Specifically there is an objective assessment of (1) pulmonary function tests (PFTs) and (2)…

An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome.

The objective of this study is to explore the efficacy and safety of gevokizumab in patients with Schnitzler syndrome.

A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis.

The overall purpose of the trial is to assess clinical efficacy and safety of three different doses of BI 655066 administered by multiple subcutaneous injections in adult patients with defined ankylosing spondylitis. We will also explore its…

The effects of BCG-vaccination on the immune response induced by influenza-vaccination in healthy volunteers. A pilot proof-of-principle study.

Primary objective: The primary objective of the study is to determine the effects of BCG-vaccination on the immune response induced by subsequent influenza vaccination in healthy volunteers. This will be determined by measuring the Th1/Th2 response…

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

1. To compare the efficacy of tofacitinib, in doses of 2 mg, 5 mg, and 10 mg BID versus placebo on the ASAS20 response rate at Week 12 in subjects with active AS that have had an inadequate response to previous treatment.2. To estimate the placebo-…