Clinical Trials Logo
  1. Home
  2. Inflammatory Bowel Disease (IBD)
  3. NCT00820365

SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease — ENTRANCE  

Inflammatory Bowel Disease (IBD) Clinical Trial

Official title:
Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Clinical Trial Summary

This is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16 sites in Bulgaria, Germany and Romania.

A total of ca. 30 - 35 patients will receive SC12267 (4SC-101) tablets, 35 mg once daily for 12 weeks. First of all the patients will undergo a screening period of 1 week and a follow-up visit will be performed 4 weeks after study drug discontinuation or earlier in case of relapse during follow up. Total study duration will be up to 36 (+2) weeks.

There will be 8 study visits: one screening visit, 6 visits during the treatment period and one follow-up visit. In addition, four telephone visits will be performed at Week 6, Week 10, Week 20 (+1) and Week 36 (+2).

The duration of the entire study (first patient in till last patient out) is expected to be about 13 months.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00820365
Study type Interventional
Source 4SC AG
Contact
Status Completed
Phase Phase 2
Start date March 2009
Completion date March 2011
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT01022749 - Efficacy Safety Study of Flu Vaccine in Immunodepression Patients Phase 3
Completed NCT02461758 - Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients Phase 4
Completed NCT01095042 - Cognition and Emotion in the SII and IBD N/A
Completed NCT00542776 - Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine N/A
Completed NCT02778464 - Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease
Completed NCT02256605 - Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens N/A
Recruiting NCT05078879 - Empagliflozin as a Treatment for Severe Congenital Neutropenia Due to G6PC3 Deficiency Phase 1
Completed NCT05596422 - A Study of Vedolizumab and Biologic Agents in Participants With Inflammatory Bowel Disease (IBD)
Completed NCT02355834 - Faecal Incontinence iNtervention Study N/A
Not yet recruiting NCT01852097 - An Online Intervention to Address Barriers to IBD Medication Adherence N/A
Terminated NCT00325078 - Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease Phase 1/Phase 2
Terminated NCT03886753 - Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products
Recruiting NCT04345393 - Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes N/A
Completed NCT01819766 - Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease N/A
Completed NCT01560819 - Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases Phase 1
Completed NCT02156557 - Study of KCC Peptide Application in the Colon Phase 1
Completed NCT01364896 - Anal Human Papillomavirus in Inflammatory Bowel Disease Study
Terminated NCT00152620 - Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease N/A