Colitis, Ulcerative Clinical Trial
Official title:
A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN- LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.
This is a Phase 2a, single arm, two-stage study in subjects with moderate to severe ulcerative colitis. Subjects will receive 500 mg of PF-06480605 intravenously every 2 weeks for a total of 7 doses. Blood, stool, and tissue samples will be collected at various time points throughout the study to evaluate safety, tolerability, efficacy, pharmacokinetics, and immunogenicity. Duration of participation for subjects will be approximately 8 months. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04989907 -
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
|
||
Completed |
NCT03494764 -
Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares
|
Phase 2 | |
Recruiting |
NCT03937609 -
TITRATE (inducTIon for acuTe ulceRATivE Colitis)
|
Phase 4 | |
Completed |
NCT00503243 -
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT03606499 -
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
|
||
Completed |
NCT02537210 -
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis
|
N/A | |
Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
Completed |
NCT00488631 -
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT00928681 -
A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
|
Phase 1 | |
Recruiting |
NCT05242484 -
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT01036022 -
Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
|
Phase 2 | |
Recruiting |
NCT03841045 -
Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
|
||
Active, not recruiting |
NCT05528510 -
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT02825914 -
CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)
|
N/A | |
Recruiting |
NCT06049017 -
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT04567628 -
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
|
||
Withdrawn |
NCT05999708 -
A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT05611671 -
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
|
Phase 2 | |
Active, not recruiting |
NCT03596645 -
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT03648541 -
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
|
Phase 2 |