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A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…

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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy

The objectives of this study are to determine the efficacy and safety of multiple doses of ABT-494 versus placebo and to assess the pharmacokinetics (PK) of ABT-494 following oral administration in subjects with moderately to severely active Crohn…

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 Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis

Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…

A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn*s Disease

Primary Objectives* To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active CD* To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.Secondary Objectives* To explore the PK…

Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.

The primary objective is to evaluate the safety of PEG-liposomal prednisolone sodium phosphate (Nanocort) The secondary objectives of this study are:To explore the efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) To evaluate the…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL
GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND
EFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH
MODERATE TO SEVERE CROHN'S DISEASE

Primary objective: The primary objective of the study is to evaluate the dose-response of tofacitinib in inducing clinical remission in subjects with moderate to severe Crohn*s disease and to select effective doses. Secondary objectives: -To…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn*s Disease

To evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn*s Disease Activity Index (CDAI) remission (CDAI < 150) at week 8.

Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

Primary:* To evalaute the efficacy of three doses of norUDCA vs. placebo for the treatment of PSC* To identify efficacious norUDCA dose(s) for the treatment of PSC for further evaluation in phase III. Secondary:* To study safety and tolerability (…

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis

The primary hypothesis of this study is that a dose-response relationship exists between disease activity as measured by the change from baseline in the Mayo score at Week 8 and JNJ-54781532 treatment regimens in subjects with moderately to severely…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's Disease

Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn*s Disease.

Transplantation of faeces in ulcerative colitis; restoring nature*s homeostasis

Primary objective: to study the effect of faecal transplantation in a phase II randomised placebo controlled design on simple clinical colitis activity index (SCCAI) and endoscopic Mayo score. Secondary objective: to study intra individual changes…

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)

Primary objective:Compare the efficacy of BMS-936557 versus placebo for induction of clinical remission (defined as Mayo score * 2 points with no individual subscore > 1 point) at Week 7 (IP-50).Secondary objective* Compare the efficacy of…

A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis (CCX115393)

Primary: efficacy of GSK1605786 at week 12 following twice daily administration at 500 mg in patients with active ulcerative colitis. Secondary: safety and tolerability, time course of the efficacy of GSK1605786 continued for up to 16 weeks, anti-…

A two-part, multi-centre, randomized, placebo-controlled, double-blind study, of TRK-170 for the treatment of Crohn's disease.

The purpose of the collected study information is research, development and safety analysis of TRK-170.

A Randomized, Double-blind, Multiple Dose Placebo-Controlled Study to
Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with
Moderate to Severe Ulcerative Colitis

Evaluation the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score >= 2 points, with no individual subscore > 1 point.

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN*S DISEASE (OPERA)

The primary objective is to determine the number of subjects that experience a decrease in CDAI (Crohn*s Disease Activity Index) of at least 70 points by the Week 8 or Week 12 assessment.

Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:
A Double-blind, Randomized Placebo-controlled Pilot Study

1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF number, size and rate of dysplasia, relative to the placebo group. 2) Gain mechanistic insight into the chemopreventive properties of 5-ASA…

A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Primary: assess the effect of tralokinumab compared with placebo in patients with active ulcerative colitis by assessment of clinical response, as defined by the Mayo score, at week 8.Other objectives: assess the change in (partial) Mayo scores…