A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety

A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease — FENNEL

Ulcerative Colitis Clinical Trial

Official title:
A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease

See also
Status	Clinical Trial	Phase
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Not yet recruiting	`NCT05953402` - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Recruiting	`NCT03950232` - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	Phase 3
Completed	`NCT03124121` - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels	Phase 4
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Withdrawn	`NCT04209556` - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis	Phase 2
Terminated	`NCT00061282` - Clotrimazole Enemas for Pouchitis in Children and Adults	Phase 1/Phase 2
Recruiting	`NCT04398550` - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis	N/A
Recruiting	`NCT04314375` - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	Phase 4
Active, not recruiting	`NCT04857112` - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis	Phase 2
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting	`NCT04033445` - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	Phase 2/Phase 3
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting	`NCT06221995` - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting	`NCT04767984` - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis	Phase 2
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT06071312` - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach	Phase 1/Phase 2
Completed	`NCT03760003` - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis	Phase 2
Not yet recruiting	`NCT05539625` - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis	Phase 2

NCT number	NCT03478956
Study type	Interventional
Source	Hoffmann-La Roche
Contact
Status	Terminated
Phase	Phase 1
Start date	March 27, 2018
Completion date	September 27, 2023

A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease — FENNEL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms