# 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

> **NCT03478956** · PHASE1 · TERMINATED · sponsor: **Hoffmann-La Roche** · enrollment: 24 (actual)

## Conditions studied

- Ulcerative Colitis
- Crohn's Disease

## Interventions

- **DRUG:** Etrolizumab

## Key facts

- **NCT ID:** NCT03478956
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2018-03-27
- **Primary completion:** 2019-12-02
- **Final completion:** 2023-09-27
- **Target enrollment:** 24 (ACTUAL)
- **Why stopped:** The study was terminated due to program discontinuation, based on mixed efficacy results in the adult ulcerative colitis and Crohn's disease studies. There were no safety concerns.
- **Last updated:** 2024-12-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03478956

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03478956, "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". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT03478956. Licensed CC0.

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