Clinical trial NCT00072839: Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease
Official title: A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2003-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers.
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Washington
country: United States
facility: Rx Trials
state: District of Columbia
city: Boca Raton
country: United States
facility: Clinical Trials Management of Boca Raton
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: North Miami Beach
country: United States
facility: Venture Research
state: Florida
city: Sarasota
country: United States
facility: Visions Clinical Research - Sarasota
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Pinnacle Trials
state: Georgia
city: Atlanta
country: United States
facility: Saint Joseph's Health System
state: Georgia
city: Chicago
country: United States
facility: Northwestern University School of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Asher Kornbluth, MD, PC
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital-Allegheny Ctr for Digestive Diseases
state: Pennsylvania
city: Houston
country: United States
facility: Methodist Hospital/Baylor University
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Madison
country: United States
facility: Dean Foundation Research Center
state: Wisconsin
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Odyssey Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences
state: Nova Scotia
city: Toronto
country: Canada
facility: Life Screening Centres
state: Ontario
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.