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A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease

NCT03681067 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-04-28

No results posted yet for this study

Summary

This trial aims to investigate the safety, tolerability and clinical activity of humanised antibody GSK1070806 delivered via intravenous infusion in the treatment of patients with moderate-to-severe Crohn's disease. 30-36 patients will be enrolled into the trial, with two thirds of the patients receiving active drug and one third receiving placebo. After 30 patients have been recruited into the study the sample size will be reassessed and up to an additional 6 patients could be recruited (i.e. up to 36 patients).

Conditions

  • Crohn Disease

Interventions

DRUG

GSK1070806

GSK1070806 100mg/ml injectable solution will be delivered via intravenous infusion as a single infusion

DRUG

Placebo- sodium chloride

Placebo injectable solution will be delivered via intravenous infusion as a single infusion

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University Hospital Birmingham

    collaborator OTHER

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Marietta Iacucci, MD,PhD · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2020-06-02
Completion
2020-06-02

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03681067 on ClinicalTrials.gov