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

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

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: placebo; Drug: Teduglutide 0.05 dose; Drug: teduglutide 0.1 mg dose; Drug: ALX-0600; Drug: teduglutide 0.05; Drug: teduglutide 0.2 mg

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1L5
      • Vancouver General Hospital
    • Victoria, British Columbia, Canada, V8T 5G4
      • Odyssey Research
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Center
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Queen Elizabeth II Health Sciences
  • Ontario
    • Toronto, Ontario, Canada, M5S 2A5
      • Life Screening Centres
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Advanced Clinical Therapeutics
  • Colorado
    • Lakewood, Colorado, United States, 80401
      • Rocky Mountain Gastroenterology
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Rx Trials
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Clinical Trials Management of Boca Raton
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • North Miami Beach, Florida, United States, 33162
      • Venture Research
    • Sarasota, Florida, United States, 34239
      • Visions Clinical Research - Sarasota
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
    • Atlanta, Georgia, United States, 30329
      • Pinnacle Trials
    • Atlanta, Georgia, United States, 30342-1764
      • Saint Joseph's Health System
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60619
      • Northwestern University School Of Medicine
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates
    • New York, New York, United States, 10128
      • Asher Kornbluth, MD, PC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital-Allegheny Ctr for Digestive Diseases
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital/Baylor University
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire DVAMC
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Dean Foundation Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: GATTEX
Experimental: teduglutide; 0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen	Drug: ALX-0600; teduglutide; Other Names: GATTEX; Drug: teduglutide 0.05; 0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen; Other Names: GATTEX; Drug: teduglutide 0.2 mg; 0.2 mg/kg/d subcutaneously injected into thigh or abdomen; Other Names: GATTEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2003
• Primary Completion (Actual): July 28, 2005
• Study Completion (Actual): July 28, 2005

Study Registration Dates

• First Submitted: November 11, 2003
• First Submitted That Met QC Criteria: November 12, 2003
• First Posted (Estimate): November 13, 2003

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Radiation-Protective Agents; Teduglutide
• Other Study ID Numbers: CL0600-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No