Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Drug: ALX-0600; Drug: placebo; Drug: teduglutide 0.05; Drug: teduglutide 0.2 mg; Drug: Teduglutide 0.05 dose; Drug: teduglutide 0.1 mg dose	Phase 2

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease
Study Start Date :	October 2003
Actual Primary Completion Date :	July 2005
Actual Study Completion Date :	September 2005

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; placebo solution injected subcutaneously daily into either thigh or abdomen.	Drug: placebo; placebo solution injected subcutaneously
Experimental: teduglutide 0.05; teduglutide 0.05 mg/kg/d injected subcutaneously daily.	Drug: Teduglutide 0.05 dose; 0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen; Other Name: GATTEX
Experimental: teduglutide 0.1; 0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen	Drug: teduglutide 0.1 mg dose; 0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen; Other Name: GATTEX
Experimental: teduglutide; 0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen	Drug: ALX-0600; teduglutide; Other Name: GATTEX; Drug: teduglutide 0.05; 0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen; Other Name: GATTEX; Drug: teduglutide 0.2 mg; 0.2 mg/kg/d subcutaneously injected into thigh or abdomen; Other Name: GATTEX

Outcome Measures

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Primary Outcome Measures :

1. The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8. [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures :

1. The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers. [ Time Frame: 8 weeks of treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

1. Men and women, 18 years of age and older
2. Signed and dated informed consent to participate before any study-related procedures are performed
3. Diagnosis of Crohn's disease for at least 6 months that has been documented and confirmed
4. A Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive
5. Female subjects who are not surgically sterile or postmenopausal must use medically acceptable methods of birth control during and for 30 days after the treatment period.
6. HCT 30% or greater
7. WBC 3.5 x 109/L or greater
8. Platelets 100 x 109/L or greater
9. Adequate renal function defined as: serum creatinine and BUN 1.5 x ULN or less
10. Adequate hepatic function defined as: ALT/SPGT, AST/SGOT 2.0 x ULN or less; total bilirubin 1.25 x ULN or less, alkaline phosphatase 1.5 x ULN or less
11. Female subjects of childbearing potential must have negative urine pregnancy test results prior to randomization
12. A stool sample must be taken at screening and analyzed by a local laboratory for enteric pathogens, pathogenic ova and parasites, and Clostridium difficile toxin, and reported negative prior to randomization.
13. C-reactive protein value must be 1.0 mg/dL or more, unless there are obvious manifestations of currently active Crohn's disease such as positive observations on endoscopy, other positive indications by laboratory test results, or the subject has had a previous intestinal resection for Crohn's disease.

Exclusion Criteria

1. Nutritionally compromised subjects requiring enteral or parenteral therapy to maintain weight
2. Body weight less than 40 kg or more than 100 kg
3. Bowel obstruction or any condition that may predispose to its development, intestinal perforation, or significant gastrointestinal hemorrhage
4. Current ileostomy or colostomy or extensive external fistulization (more than 3 external fistulae which are expressible with gentle compression)
5. Expected to require surgical therapy for Crohn's disease or Crohn's disease related complications within 12 weeks of screening. If an abscess is present, it should be drained at least 3 weeks before pre-screening
6. History of ulcerative colitis within 6 months of screening visit
7. Cushing's syndrome
8. Known HIV infection, or symptoms or signs of HIV infection
9. Acute systemic infection and/or intestinal infection requiring antibiotic therapy at time of screening or baseline
10. Evidence of chronic hepatitis B or C viral infection
11. Decompensated liver disease
12. Clinically significant ECG abnormalities
13. History of angina or cardiac arrhythmia requiring drug or device intervention or clinically significant congestive heart failure or other clinically significant cardiac disease
14. History of myocardial infarction within 12 months of screening
15. History of thromboembolic disease (e.g., phlebitis, pulmonary embolus) or known congenitally or acquired prothrombotic disorder (e.g., protein C deficiency)
16. History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
17. Known substance abuse in the previous 2 years
18. Nursing mothers or pregnant women
19. Use of native GLP-2, growth hormone, or growth factors within 3 months of signing informed consent
20. Use of any of the prior or concomitant medications described in section 5.4, except as specified
21. Known hypersensitivity to any of the active or inactive constituents of ALX-0600

Contacts and Locations

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  Show 26 Study Locations

Sponsors and Collaborators

Shire

Investigators

Study Director:	David Jacobs, MD	NPS Pharma

More Information

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Publications:

Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010 Jun;16(6):962-73. doi: 10.1002/ibd.21117.

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT00072839 History of Changes
Other Study ID Numbers:	CL0600-008-01
First Posted:	November 13, 2003
Last Update Posted:	November 13, 2015
Last Verified:	January 2015

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis	Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases