Trial Condition(s):
Crohn’s disease
AMG 827 in Subjects with Moderate to Severe Crohn’s Disease
Bayer Identifier:
20090072
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The study will examine the safety and effectiveness of AMG 827 for the treatment of moderate to severe Crohn’s disease. Patients will randomly receive either AMG 827 or placebo (a lookalike liquid that doesn’t have any drug in it) and neither the doctor nor the patient will know what treatment is being given.
Inclusion Criteria
-Diagnosed with ileal, ileo-colonic, or colonic Crohn’s disease for a minimum of 6 months prior to initiating Study Product -Moderately to severely active Crohn’s disease, as defined by a CDAI score >250 and <450 at baseline -Evidence of active inflammation
Exclusion Criteria
- Short bowel syndrome - Stricture with obstructive symptoms within 3 months - Bowel surgery within 3 months - Ileostomy and/or colostomy - Any gastric or intestinal pouch - Ulcerative colitis - Evidence of an infected abscess - Bowel perforation or evidence of noninflammatory obstruction during the 6 months Stool positive for C. Difficile toxin at screening - Presence of active infection requiring treatment - Serious infection within 8 weeks - Significant concurrent medical conditions - Pregnant or breast feeding - Significant Laboratory abnormalities - Any anti-TNF agent within 2 months - Steroid enemas within 2 weeks - Tysabri (natalizumab) within 1 year - Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months - Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Research Site Pontevedra, Spain | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Santiago de Compostela, Spain | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Madrid, Spain | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Birmingham, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Dithan, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Lowell, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Miami, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Jacksonville, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Hammond, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Chevy Chase, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Rochester, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Mexico, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Egg Harbor Township, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Great Neck, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Charlotte, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Wilmington, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Nashville, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Germantown, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site San Antonio, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Logan, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Ogden, United States | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Calgary, Canada | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Vancouver, Canada | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Victoria, Canada | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Winnipeg, Canada | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Toronto, Canada | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Hamilton, Canada | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site London, Canada | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Montreal, Canada | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Kurralta Park, Australia | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Barcelona, Spain | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Paris Cedex 10, France | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Box Hill, Australia | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Vandoeuvre les Nancy, France | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Fitzroy, Australia | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Paris, France | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Toulouse Cedex 09, France | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Nice Cedex 3, France | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Maastricht, Netherlands | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Bonheiden, Belgium | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Gent, Belgium | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Lille cedex, France | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Roeselare, Belgium | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Leuven, Belgium | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Fremantle, Australia | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Sopot, Poland | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Rotterdam, Netherlands | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Bydgoszcz, Poland | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Olsztyn, Poland | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Amsterdam, Netherlands | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Locations Research Site Opole, Poland | Contact Us: E-mail: Not Available Phone: 866-572-6436 |
Trial Design
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- To evaluate the efficacy of AMG 827 compared with placebo as measured by the proportion of subjects achieving Crohn’s Disease Activity Index (CDAI) remission (≤ 150) at week 6.Timeframe: 6 Weeks
Secondary Outcome
- To evaluate the efficacy of AMG 827 as measured by the proportion of subjects with a CDAI response (reduction from baseline of ≥ 100) at week 6Timeframe: 6 Weeks
- To evaluate improvement from baseline in CDAI at week 6Timeframe: 6 Weeks
- To evaluate the short term safety profile of AMG 827 in subjects with Crohn’s diseaseTimeframe: 12 Weeks
- To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Crohn’s diseaseTimeframe: 6 Weeks
Additional Information
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