Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease
A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease
1 other identifier
interventional
100
2 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2003
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2003
CompletedStudy Start
First participant enrolled
November 12, 2003
CompletedFirst Posted
Study publicly available on registry
November 13, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2005
CompletedMay 25, 2021
May 1, 2021
1.7 years
November 11, 2003
May 24, 2021
Conditions
Outcome Measures
Primary Outcomes (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.
8 weeks of treatment
Secondary Outcomes (1)
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
Study Arms (4)
Placebo
PLACEBO COMPARATORplacebo solution injected subcutaneously daily into either thigh or abdomen.
teduglutide 0.05
EXPERIMENTALteduglutide 0.05 mg/kg/d injected subcutaneously daily.
teduglutide 0.1
EXPERIMENTAL0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
teduglutide
EXPERIMENTAL0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
Interventions
0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen
0.2 mg/kg/d subcutaneously injected into thigh or abdomen
0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen
Eligibility Criteria
You may qualify if:
- Men and women, 18 years of age and older
- Signed and dated informed consent to participate before any study-related procedures are performed
- Diagnosis of Crohn's disease for at least 6 months that has been documented and confirmed
- A Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive
- 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.
- HCT 30% or greater
- WBC 3.5 x 109/L or greater
- Platelets 100 x 109/L or greater
- Adequate renal function defined as: serum creatinine and BUN 1.5 x ULN or less
- 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
- Female subjects of childbearing potential must have negative urine pregnancy test results prior to randomization
- 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.
- 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.
You may not qualify if:
- Nutritionally compromised subjects requiring enteral or parenteral therapy to maintain weight
- Body weight less than 40 kg or more than 100 kg
- Bowel obstruction or any condition that may predispose to its development, intestinal perforation, or significant gastrointestinal hemorrhage
- Current ileostomy or colostomy or extensive external fistulization (more than 3 external fistulae which are expressible with gentle compression)
- 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
- History of ulcerative colitis within 6 months of screening visit
- Cushing's syndrome
- Known HIV infection, or symptoms or signs of HIV infection
- Acute systemic infection and/or intestinal infection requiring antibiotic therapy at time of screening or baseline
- Evidence of chronic hepatitis B or C viral infection
- Decompensated liver disease
- Clinically significant ECG abnormalities
- History of angina or cardiac arrhythmia requiring drug or device intervention or clinically significant congestive heart failure or other clinically significant cardiac disease
- History of myocardial infarction within 12 months of screening
- History of thromboembolic disease (e.g., phlebitis, pulmonary embolus) or known congenitally or acquired prothrombotic disorder (e.g., protein C deficiency)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (26)
Advanced Clinical Therapeutics
Tucson, Arizona, 85712, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, 80401, United States
Rx Trials
Washington D.C., District of Columbia, 20010, United States
Clinical Trials Management of Boca Raton
Boca Raton, Florida, 33486, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Venture Research
North Miami Beach, Florida, 33162, United States
Visions Clinical Research - Sarasota
Sarasota, Florida, 34239, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Pinnacle Trials
Atlanta, Georgia, 30329, United States
Saint Joseph's Health System
Atlanta, Georgia, 30342-1764, United States
Northwestern University School of Medicine
Chicago, Illinois, 60619, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Asher Kornbluth, MD, PC
New York, New York, 10128, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Allegheny General Hospital-Allegheny Ctr for Digestive Diseases
Pittsburgh, Pennsylvania, 15212, United States
Methodist Hospital/Baylor University
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
Dean Foundation Research Center
Madison, Wisconsin, 53715, United States
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L5, Canada
Odyssey Research
Victoria, British Columbia, V8T 5G4, Canada
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9, Canada
Queen Elizabeth II Health Sciences
Halifax, Nova Scotia, B3H 1V7, Canada
Life Screening Centres
Toronto, Ontario, M5S 2A5, Canada
Related 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.
PMID: 19821509BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2003
First Posted
November 13, 2003
Study Start
November 12, 2003
Primary Completion
July 28, 2005
Study Completion
July 28, 2005
Last Updated
May 25, 2021
Record last verified: 2021-05