Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

Shire

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Teduglutide (ALX-0600)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308438

CL0600-009

Details and patient eligibility

About

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Full description

The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have completed participation in the Pilot Active Crohn's Disease Study.

• Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

  • CDAI score greater than 220
  • Stool samples not required
  • C-reactive protein levels are not an exclusion criterion

Exclusion criteria

• Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

  • Participation in a clinical study of an experimental drug or device within 30 days before signing consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

1

Experimental group

Description:

All subjects in the study dosed at 0.1 mg/kg teduglutide

Treatment:

Drug: Teduglutide (ALX-0600)