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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•…

A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjects

The purpose of the study is to compare LA-EP2006 and Neulasta® with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called pharmacokinetics). It…

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN COMBINATION WITH METHOTREXATE FOR INDUCING AND SUSTAINING CLINICAL RESPONSE IN THE TREATMENT OF DMARD-NAÏVE ADULTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS

The study has the following 3 main objectives pertaining to the treatment of DMARD-naïve subjects with adult-onset, early, active, RA, diagnosed within 1 year before Screening using the 2010 ACR/EULAR RA classification criteria:1.To show that…

The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.

In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…

A phase III, multicenter, randomized, double-blind placebo-controlled study to assess the efficacy and safety of Tocilizumab in subjects with giant cell arteritis.

Primary Efficacy Objective:• To evaluate the efficacy of tocilizumab (TCZ) compared to placebo, in combination with a26-week prednisone taper regimen, in patients with giant cell arteritis (GCA), as measured by the proportion of patients in…

Cytokine inhibition in Chronic Fatigue Syndrome patients - a pilot study

To investigate the effect on symptomatology of interference with IL-1 in CFS patients.

Randomized double blind placebo-controlled clinical safety, tolerability and pharmacokinetic/-dynamic study on the effects of escalating single intravenous doses of EA-230 on the innate immune response during experimental human endotoxemia

Part 1: To assess the safety, tolerability and pharmacokinetic-dynamic response, of single escalating doses of EA-230 in healthy subjects.Part 2: To assess the dose-and plasma concentration-response relation of single escalating doses EA-230 on…

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and
Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care
Compared With Best Supportive Care in Subjects With Multicentric Castleman*s
Disease

Primary Objective:The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superiorto BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjectswith multicentric Castleman…

The effects of immunostimulation with GM-CSF or IFN-γ on immunoparalysis following
human endotoxemia.
A parallel randomised double-blind placebo-controlled study

Primary objective: The primary objective of the study is to determine the effects of GM-CSF/IFN-γ on the in vivo immunoparalysis induced by human endotoxemia. This will be determined by measuring plasma levels of various pro and anti-inflammatory…

A PHASE I, RANDOMIZED, DOUBLE BLIND PLACEBO * CONTROLLED, SINGLE AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF OCID 2987 IN HEALTHY MALE SUBJECTS

Primary:-To determine the safety and tolerability of ascending single and multiple oral doses of OCID 2987 in healthy male subjects.Secondary:-To determine the pharmacokinetics (PK) of single and multiple oral dose OCID 2987 in healthy male subjects…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND THE EFFECT OF FOOD AND KETOCONAZOLE ON THE PHARMACOKINETICS OF IPI-145 WHEN ADMINISTERED TO HEALTHY ADULT SUBJECTS

The study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…

Single-center, double-blind, randomized, placebo-controlled, single-ascending dose
and food interaction study to investigate the tolerability, safety, pharmacokinetics,
and pharmacodynamics of ACT-389949 in healthy male subjects

• to evaluate the safety and tolerability of ascending single oral doses of the test compound ACT-389949 (test medication) in healthy male subjects• to study how the test compound ACT-389949 is absorbed, broken-down and excreted by the body and how…

A double blind, placebo controlled Phase 2 dose ranging study of the effects of ARA 290 on corneal nerve fiber density and neuropathic symptoms of subjects with sarcoidosis

ARA290 is a new drug against neuropathic pain and was succesfully tested in previous studies on patients with neuropathic pain due to diabetes and sarcoidosis. The current study involves sarcoidosis patients with pain due to neuropathy. The purpose…

A multicenter, double-blind, randomized, active controlled, parallel-group study
to evaluate the efficacy, safety, tolerability, and pharmacodynamic profiles of TL011 infusions
compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis
treated with methotrexate (MTX)

Primary objective: to demonstrate equivalence of the efficacy of TL011 in comparison with the reference product MabThera(rituximab) in subjects with severe, active RA treated with MTX.• Secondary objective: To assess the pharmacodynamics (PD),…

A PHASE 1, THREE-PART, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF AQX-1125 IN HEALTHY HUMAN SUBJECTS

Primary:To assess the safety and tolerability of single and multiple oral ascending doses of the study drug in healthy human subjects (Part 1 and Part 2)To assess the effect of food on the absorption and pharmacokinetic (PK) profile of the study…

A PROSPECTIVE RANDOMIZED STUDY ON THE EFFICACY AND SAFETY OF THE PROPHYLACTIC USE OF RITUXIMAB, ADDED TO STANDARD IMMUNOSUPPRESSIVE TREATMENT IN COMPARISON WITH STANDARD IMMUNOSUPPRESSIVE TREATMENT ALONE IN RENAL TRANSPLANTATION

To determine the effect of rituximab, when added to standard immunsuppressive therapy, on the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.

A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment

Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change at 26 weeks.

Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery

To assess safety and tolerability of EA-230 in patients undergoing cardiac surgery with cardiopulmonary bypass.To assess the anti-inflammatory effects of EA-230 in patients with systemic inflammation following cardiac surgery. To assess the effects…

The effects of different vasopressors on the innate immune response during experimental human endotoxemia, a pilot proof-of-principle study

Our primary objective is to investigate whether noradrenaline exerts immunomodulatory effects in humans in vivo during experimental human endotoxemia. This will be determined by comparing plasma levels of various pro- and anti-inflammatory cytokines…

A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF)

Primary: • Assessment of the safety and tolerability of PLN-74809 Secondary:• Assessment of pharmacokinetics (PK) of PLN-74809 Exploratory:• Assessment of change from baseline in forced vital capacity (FVC) • Assessment of change from baseline in…