Phase 2
Completed N=45
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Source: ClinicalTrials.gov NCT01959165 ↗Enrolled (actual)
45
Serious AEs
4.6%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Remission at Week 8 — 0; 1; 2; 1 Participants
Summary
This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Remission at Week 8 |
0; 1; 2; 1 | — |
| SECONDARY Number of Participants With Response at Week 8 |
7; 3; 6; 6 | — |
| SECONDARY Number of Participants With Mucosal Healing at Week 8 |
4; 1; 4; 4 | — |
| SECONDARY Number of Participants With Response at Week 12 |
6; 3; 6; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Diagnosis of UC established 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 rectosigmoidoscopy score ≥ 2 during screening period
- Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or Anti- TNF-α agents. etc.
Exclusion Criteria
- Disease limited to the rectum
- 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 12 weeks from Visit 2
- Stool positive for C. difficile toxin at screening
- Primary Sclerosing Cholangitis
- History of gastrointestinal surgery within 8 weeks of Visit 2
- 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
- Subjects with positive HBsAg, HBsAb, HBcAb or HCVAb serology at screening etc
Data sourced from ClinicalTrials.gov (NCT01959165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.