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A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease

NCT01635621 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-10-30

No results posted yet for this study

Summary

The primary purpose of this multi-centre, double blind-study is to evaluate the clinical response of patients with moderate to severe Cohn's Disease (CD) following treatment with different doses and dose regimens of Olokizumab, relative to placebo.

Conditions

Interventions

DRUG

Olokizumab (OKZ)

Subjects will receive one of the following treatment regimens as subcutaneous injection solution on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period: * OKZ 120 mg every 2 weeks * OKZ 240 mg every 2 weeks * OKZ 120 mg every 2 weeks, with a loading dose of OKZ 480 mg at Week 0 1.6 mL of OKZ drug substance presented in a glass vial with a 1.2 mL extractable volume at a concentration of 100 mg/mL in the formulation buffer, containing 25 mM sodium citrate, 90 mM sodium chloride, 0.02 % (weight/volume) polysorbate 80, pH 6.0.

DRUG

Placebo

Subjects will receive Placebo every 2 weeks as a subcutaneous injection solution (0.9% sodium chloride preservative-free for injection) on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period.

Sponsors & Collaborators

  • UCB BIOSCIENCES GmbH

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-08-31
Completion
2013-08-31

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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 NCT01635621 on ClinicalTrials.gov