Moderate to severe Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¦ Age 18 to 65 at screening (inclusive) ¦ Diagnosis of UC established = 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report ¦ Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a rectosigmoidoscopy score = 2 prior to baseline ¦ Subjects can be receiving the following treatments: • Azathioprine or 6 mercaptopurine if treatment initiated at least 12 weeks prior to baseline and if stable dosage for = 8 weeks prior to baseline • Methotrexate up to 25 mg/week if stable dosage for = 8 weeks prior to baseline • 5 aminosalicylates and/or oral prednisone or equivalent up to 20 mg/day, if stable dosage for = 2 weeks prior to baseline ¦ Neurological exam free of clinically significant, unexplained signs or symptoms in the opinion of the investigator at screening ¦ Subject has no known history of active tuberculosis ¦ Subject has a negative test for tuberculosis during screening ¦ Subject has provided informed consent For full list of inclusion criteria, please refer to section 4.1 of the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 305 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Disease specific: ¦ Disease limited to the rectum (ie, within 10 cm of the anal verge) ¦ Toxic megacolon ¦ Crohn’s Disease ¦ History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC ¦ Stool positive for C. Difficile toxin at screening Excluded Medications: ¦ Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate mofetil, within 1 month prior to baseline ¦ Prior exposure to anti TNF agents, within 2 months, or 5 times the respective elimination half life (whichever is longer) prior to baseline ¦ Any prior exposure to vedolizumab, rituximab, efalizumab, natalizumab ¦ Use of topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to baseline ¦ Use of intravenous corticosteroids within 2 weeks prior to screening and during screening Laboratory Abnormalities: ¦ Abnormal laboratory results at screening: •Liver tests: either aspartate aminotransferase (AST), alanine transaminase (ALT) or alkaline phosphatase (ALP) > 2.0 Upper Limit of Normal (ULN) OR total bilirubin (TBL) > 1.5 ULN (except for subjects with Gilbert Syndrome) • White blood cell count < 3,000 cells/mm³(< 3 x 10^9/L in SI units) •Hemoglobin < 10 g/dL General: ¦ Female subject is not willing to use two highly effective methods of birth control during treatment and for = 7 months after the last dose of investigational product (except if = 2 years postmenopausal or surgically sterile) ¦ Subject is pregnant or breast feeding, or might become pregnant within 7 months after the last dose of investigational product For full list of exclusion criteria, please refer to section 4.2 of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score = 2 points, with no individual subscore > 1 point ;Secondary Objective: Key Secondary Objectives: - To evaluate the effects of AMG 181 on induction of response at week 8 as assessed by the total Mayo Score - To evaluate the effects of AMG 181 on mucosal healing at week 8 as assessed by rectosigmoidoscopy Other Secondary objective: - To evaluate the effects of AMG 181 on sustained remission at both week 8 and week 24 as assessed by the total Mayo Score ;Primary end point(s): Remission at week 8 defined by a total Mayo Score = 2 points, with no individual subscore > 1 point;Timepoint(s) of evaluation of this end point: at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints - Response at week 8 as defined by a decrease from baseline in the total Mayo Score of = 3 points and = 30%, with an accompanying decrease in the subscore for rectal bleeding of = 1 point or an absolute subscore for rectal bleeding of 0 or 1 - Mucosal healing at week 8 as defined by an absolute subscore for rectosigmoidoscopy of 0 or 1 Other Secondary Endpoints: - Sustained remission at both week 8 and week 24 ;Timepoint(s) of evaluation of this end point: key secondary endpoints: at week 8 Other secondary endpoint (i.e. sustained remission): week 8 and week 24 | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Norway, Poland, Switzerland, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed