Status:
TERMINATED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Ulcerative Colitis
Crohn's Disease
Eligibility:
All Genders
4-17 years
Phase:
PHASE1
Brief 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 t...
Eligibility Criteria
Inclusion
- Age of 4 years to \<18 years at the time of signing the Informed Consent Form.
- Weight of 13 kilograms (kg) or more
- Diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) confirmed by biopsy and established for ≥3 months (i.e., after first diagnosis by a physician according to American College of Gastroenterology \[ACG\] guidelines) prior to screening
- Inadequate response, loss of response or intolerance to prior immunosuppressants and/or corticosteroid treatment and/or anti-tumor necrosis factor (TNF) therapy
- For postpubertal females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for at least 24 weeks after the last dose of etrolizumab.
- For male patients: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion
- Pregnant or lactating
- Lack of peripheral venous access
- Congenital or acquired immune deficiency
- Neurological conditions or diseases that may interfere with monitoring for progressive multifocal leukoencephalopathy (PML)
- History of demyelinating disease
- History of cancer, including hematologic malignancy, solid tumors, and carcinoma in situ, within 5 years before screening
- Exclusion Criteria Related to Inflammatory Bowel Disease:
- Prior extensive colonic resection, subtotal or total colectomy, or planned surgery
- Past or present ileostomy or colostomy
- Diagnosis of indeterminate colitis
- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- Diagnosis of toxic megacolon within 12 months of initial screening visit
- Abdominal abscess
- A history or current evidence of colonic mucosal dysplasia
- Patients with fixed symptomatic stenosis of the intestine
- Patients with history or evidence of adenomatous colonic polyps that have not been removed
- Exclusion Criteria Related to Ulcerative Colitis:
- Severe extensive colitis per investigator judgment that colectomy is imminent
- Exclusion Criteria Related to Crohn's Disease:
- Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator
- Short-bowel syndrome
- Evidence of abdominal or perianal abscess
- Expected to require surgery to manage CD-related complications during the study
- Exclusion Criteria Related to Prior or Concomitant Therapy:
- Any prior treatment with anti-integrin agents (including natalizumab, vedolizumab, and efalizumab), ustekinumab, anti-adhesion molecules (e.g., anti-MAdCAM-1), or rituximab
- Use of IV steroids within 30 days prior to screening with the exception of a single administration of IV steroid
- Use of agents that deplete B or T cells (e.g., alemtuzumab or visilizumab) within 12 months prior to Day 1, with the exception of AZA and 6-MP
- Use of cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 4 weeks prior to Day 1
- Use of other biologics (e.g. anti-TNF) within 8 weeks before dosing (unless drug level is below detectability before completion of the 8-week interval)
- Chronic nonsteroidal anti-inflammatory drug (NSAID) use
- Patients who are currently using anticoagulants
- Apheresis (i.e., Adacolumn apheresis) within 2 weeks prior to Day 1
- Received any investigational treatment including investigational vaccines within 12 weeks prior to Day 1 of the study or 5 half-lives of the investigational product, whichever is greater
- History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies, fusion proteins, or murine proteins or hypersensitivity to etrolizumab (active drug substance) or any of the excipients (L-histidine, L-arginine, succinic acid, polysorbate 20)
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03478956
Start Date
March 27 2018
End Date
September 27 2023
Last Update
December 27 2024
Active Locations (5)
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1
Hôpital Enfants Reine Fabiola
Brussels, Belgium, 1020
2
Gabinet Lekarski, Bartosz Korczowski
Rzeszów, Poland, 35-302
3
Centrum Zdrowia MDM
Warsaw, Poland, 00-189
4
Hospital Niño Jesus; Servicio de Pediatria - Gastrenterologia y Nutricion
Madrid, Spain, 28009