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A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
For more information, please contact Incyte Corporation at 1.855.463.3463
Phase
2Span
Sponsor
New Pt Richey, Florida
Recruiting
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
Phase
3Span
474 weeksSponsor
OBI Pharma, IncNew Port Richey, Florida
Recruiting
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
Primary objectives This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage F2 or F3 and consists of 2 sequential parts - an initial double-blind placebo-controlled (DBPC) period (Part A) followed by a double-blind active treatment extension (ATE) period (Part B), with the following primary objectives: Part A To assess the safety and efficacy of lanifibranor compared to placebo on 'NASH resolution and improvement of fibrosis' assessed by liver histology. Part B To assess the safety of lanifibranor beyond the DBPC period. Secondary objectives Key secondary objectives of Part 1: - To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis - To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH Other secondary objectives of both Part 1 and Part 2: - To assess the effect of lanifibranor on other key histological features of NASH (only for DBPC period) - To assess the effect of lanifibranor on NASH resolution and improvement of fibrosis in diabetic patients (only for DBPC period) - To assess the effect of lanifibranor on liver tests - To assess the effect of lanifibranor on glycaemic parameters - To assess the effect of lanifibranor on lipid parameters - To assess the effect of lanifibranor on liver stiffness and steatosis assessed by elastography. - To assess the effect of lanifibranor on health-related quality of life - To assess the safety of lanifibranor - To assess population PK modeling through plasma levels of lanifibranor using sparse sampling scheme (only for DBPC period)
Phase
3Span
267 weeksSponsor
Inventiva PharmaNew Port Richey, Florida
Recruiting
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
Phase
2Span
266 weeksSponsor
AstraZenecaNew Port Richey, Florida
Recruiting
Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Phase
N/ASpan
208 weeksSponsor
Capso Vision, Inc.New Port Richey, Florida
Recruiting
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Phase
3Span
134 weeksSponsor
Abivax S.A.New Port Richey, Florida
Recruiting
VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
Phase
2Span
131 weeksSponsor
Vedanta Biosciences, Inc.New Port Richey, Florida
Recruiting
New Port Richey, Florida
Recruiting
Data Collection for CV-3E AI Software Development
Phase
N/ASpan
20 weeksSponsor
Capso Vision, Inc.New Port Richey, Florida
Recruiting
Healthy Volunteers
A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))
Phase
2Span
163 weeksSponsor
SanofiNew Port Richey, Florida
Recruiting