AMG 181 Phase 2 Study in Subjects with Moderate to Severe Ulcerative Colitis
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-006119
NCT ID: NCT01694485
Sponsor Protocol Number: 20110166
About this study
This is a randomized, double blind, placebo controlled, parallel group, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (total Mayo Score < 2 points with no individual subscore > 1 point) at week 8. After completing all screening assessments and meeting all eligibility criteria, subjects will be randomized to receive placebo or AMG 181 at various doses per protocol. A maximum of approximately 50% of subjects with any prior anti-TNF agent use will be allowed in the study. At the end of the double blind period, subjects will enter an open label period during which all subjects will receive open label AMG 181 at a single dose level according to protocol. Subjects who failed to achieve a response at week 8 and also have an inadequate response at week 12 or after are eligible to enter the open label period of the study early. Subjects who achieved response and/or remission at week 8 and subsequently experience disease worsening are eligible to enter the open label period early ONLY if a confirmatory rectosigmoidoscopy confirms disease severity as defined by protocol. Subjects that complete the open label period or early terminate from the study will enter the 2 year safety follow up period.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- 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 centrally read rectosigmoidoscopy score ≥2 prior to baseline
- Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments:
- Anti-TNF agents
- Corticosteroids (non-US sites only)
- Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization
- No known history of active tuberculosis and negative test for tuberculosis during screening
- Other inclusion criteria as per protocol
- 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
- Planned bowel surgery within 24 weeks from baseline
- Stool positive for C. Difficile toxin at screening
- History of gastrointestinal surgery within 8 weeks of baseline
- Primary Sclerosing Cholangitis
- Any uncontrolled or clinically significant systemic disease
- Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion
- Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody or HIV
- Underlying condition that predisposes subject to infections (eg, uncontrolled diabetes; history of splenectomy)
- Known history of drug or alcohol abuse within 1 year of screening
- Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease free state since treatment)
- 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 or intramuscular corticosteroids within 2 weeks prior to screening and during screening
- Previously treated with AMG 181
- Received any type of live attenuated vaccine < 1 month prior to baseline or is planning to receive any such live attenuated vaccine over the course of the study
- Treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals
- Abnormal laboratory results at screening
- Any other laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
- Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s).
- Other investigational procedures are excluded
- Pregnant or breast feeding
- Other exclusion criteria as per protocol
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Edward Loftus, M.D.
Contact us for the latest status