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

Crohn's Disease Clinical Trial

Official title:

A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072839
• Other study ID #: CL0600-008
• Status: Completed
• Phase: Phase 2
• Start date: November 12, 2003
• Est. completion date: July 28, 2005

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 28, 2005
• Est. primary completion date: July 28, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• ALX-0600
teduglutide
• placebo
placebo solution injected subcutaneously
• teduglutide 0.05
0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen
• teduglutide 0.2 mg
0.2 mg/kg/d subcutaneously injected into thigh or abdomen
• Teduglutide 0.05 dose
0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
• teduglutide 0.1 mg dose
0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences	Halifax	Nova Scotia
Canada	Life Screening Centres	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Odyssey Research	Victoria	British Columbia
Canada	Health Sciences Center	Winnipeg	Manitoba
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Pinnacle Trials	Atlanta	Georgia
United States	Saint Joseph's Health System	Atlanta	Georgia
United States	Clinical Trials Management of Boca Raton	Boca Raton	Florida
United States	Northwestern University School of Medicine	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Methodist Hospital/Baylor University	Houston	Texas
United States	Rocky Mountain Gastroenterology	Lakewood	Colorado
United States	University of Louisville	Louisville	Kentucky
United States	Dean Foundation Research Center	Madison	Wisconsin
United States	Asher Kornbluth, MD, PC	New York	New York
United States	Venture Research	North Miami Beach	Florida
United States	Allegheny General Hospital-Allegheny Ctr for Digestive Diseases	Pittsburgh	Pennsylvania
United States	McGuire DVAMC	Richmond	Virginia
United States	University of Utah	Salt Lake City	Utah
United States	Visions Clinical Research - Sarasota	Sarasota	Florida
United States	Advanced Clinical Therapeutics	Tucson	Arizona
United States	Rx Trials	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 weeks of treatment
Secondary	The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers.		8 weeks of treatment