Clinical Trials Logo
  1. Home
  2. Colitis, Ulcerative
  3. NCT01959282

A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

Official title:
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

Clinical Trial Summary

The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Clinical Trial Description

This is a Phase 2b, multicenter, randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), parallel-group (each group of participants will be treated at the same time), dose-response study (a study to evaluate response to different dosages of study medication) of oral tablets of JNJ-54781532 in adult participants with moderately to severely active UC. Approximately 220 participants will be randomized in a 1:1:1:1:1 ratio to 1 of 5 treatment groups at Week 0 (placebo; JNJ-54781532 25 mg once daily; JNJ-54781532 75 mg once daily; JNJ-54781532 150 mg once daily; and JNJ-54781532 75 mg twice daily) to receive their randomized dosage of study medication through Week 8 and will be assessed for clinical response at Week 8. Participants who achieve clinical response at Week 8 will continue to receive their original randomized dosage of study medication through Week 32. Participants who do not achieve clinical response at Week 8 will be treated as follows: participants originally randomized to placebo will receive JNJ-54781532 150 mg once daily through Week 16; participants originally randomized to JNJ-54781532 will continue to receive their original randomized dosage of JNJ-54781532 through Week 16. Participants who were not in clinical response at Week 8 and do not achieve a partial Mayo score response (a decrease from baseline in the partial Mayo score by ≥3 points) at Week 16 will be discontinued from study medication; and those who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 through Week 32. Participants will be evaluated for safety (adverse events) up to Week 36 (ie, 4 weeks after the last dose of study medication). The maximum study duration for each participant will be approximately 44 weeks (including maximum screening period). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01959282
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase Phase 2
Start date November 15, 2013
Completion date December 5, 2015
View Details
See also
  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