Randomised Double Blind Clinical Trial in Acute Severe Colitis: The IASO trial

Phase 1

• Conditions: Acute Severe Ulcerative Colitis; MedDRA version: 20.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000016670; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-001389-10-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust & University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 214

Inclusion Criteria

- Patients aged 16-80 inclusive
- Have given written informed consent to participate
- Hospitalised patients with clinically confirmed or suspected acute severe ulcerative colitis and a Modified Truelove Witts Severity Index score =11
- Requirement for treatment with IV corticosteroids in the judgement of the treating clinician, with the possibility to receive a first dose of IMP within 36 hours of commencement of IV corticosteroids

Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Pregnant or breast-feeding women
- Oral corticosteroid dosing for a duration of 8 weeks or more immediately prior to commencement of IV corticosteroid dosing
- History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
- Moderate or severe renal impairment (eGFR <50ml/minute)
- Neutropenia (neutrophil count <1.5x109/l)
- Previous treatment with anakinra for any indication
- Evidence (from blood cultures etc) or clinical suspicion of systemic infection
- Current or previous cytomegalovirus (CMV) infection requiring treatment with anti-viral agents
- Current treatment with anti-TNF-a therapy or anti-TNF-a discontinuation within previous 16 weeks
- A history of pulmonary TB infection
- History of malignancy (with the exception of non-melanoma skin cancer) or colonic dysplasia
- Receipt of another IMP as part of a CTIMP within the previous 16 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified