Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease
NCT ID: NCT00072839
Last Updated: 2021-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2003-11-12
2005-07-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
NCT00308438
A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
NCT04173273
A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
NCT05013905
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease
NCT06233461
Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
NCT00102921
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
teduglutide 0.1
0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
teduglutide 0.1 mg dose
0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen
teduglutide
0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
ALX-0600
teduglutide
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
Placebo
placebo solution injected subcutaneously daily into either thigh or abdomen.
placebo
placebo solution injected subcutaneously
teduglutide 0.05
teduglutide 0.05 mg/kg/d injected subcutaneously daily.
Teduglutide 0.05 dose
0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shire
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Advanced Clinical Therapeutics
Tucson, Arizona, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States
Rx Trials
Washington D.C., District of Columbia, United States
Clinical Trials Management of Boca Raton
Boca Raton, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Venture Research
North Miami Beach, Florida, United States
Visions Clinical Research - Sarasota
Sarasota, Florida, 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
Northwestern University School of Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Asher Kornbluth, MD, PC
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Allegheny General Hospital-Allegheny Ctr for Digestive Diseases
Pittsburgh, Pennsylvania, United States
Methodist Hospital/Baylor University
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
McGuire DVAMC
Richmond, Virginia, United States
Dean Foundation Research Center
Madison, Wisconsin, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
Odyssey Research
Victoria, British Columbia, Canada
Health Sciences Center
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences
Halifax, Nova Scotia, Canada
Life Screening Centres
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CL0600-008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.