Trials / Terminated
TerminatedNCT03478956
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
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in pediatric patients of 4 to \<18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn's disease (CD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Etrolizumab | Etrolizumab was administered by subcutaneous (SC) injection as described for each treatment arm. |
Timeline
- Start date
- 2018-03-27
- Primary completion
- 2019-12-02
- Completion
- 2023-09-27
- First posted
- 2018-03-27
- Last updated
- 2024-12-27
- Results posted
- 2020-08-05
Locations
5 sites across 4 countries: Belgium, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03478956. Inclusion in this directory is not an endorsement.