a chronic relapsing and remitting gastrointestinal disorder causing inflammation of the colonic and rectal mucosa., Ulcerative Colitis is a type of inflammatory bowel disease
Conditions
Brief summary
Clinical remission at Week 12, defined as an MMS ≤ 2, with ES of ≤ 1 (excluding friability), a rectal bleeding (RB) subscore of 0, stool frequency (SF) subscore of ≤ 1 (with a ≥ 1 point decrease from baseline).
Detailed description
TEAEs, treatment-related TEAEs, SAEs, discontinuations due to treatment related TEAEs., Endoscopic remission defined as an ES ≤ 1 (excluding friability) at Week 12., MMS score at baseline and Week 12., Clinical response at Week 12 defined as: o decrease from baseline in the MMS of ≥ 2 points and at least a 30% reduction from baseline, and o decrease ≥ 1 point in RB from baseline or RB of ≤ 1, Histologic improvement (as defined in the Statistical Analysis Plan [SAP]) at Week 12.
Interventions
DRUGThe placebo is a solution of the same formulation excipients at the same concentration and ph as as the xmab942 drug product except that it contains no active ingredient; consists of 20 mm histidine buffer
DRUG7% (w/v) sucrose
DRUGand 0.04% polysorbate 80 at ph 6.0.
Sponsors
Xencor Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission at Week 12, defined as an MMS ≤ 2, with ES of ≤ 1 (excluding friability), a rectal bleeding (RB) subscore of 0, stool frequency (SF) subscore of ≤ 1 (with a ≥ 1 point decrease from baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| TEAEs, treatment-related TEAEs, SAEs, discontinuations due to treatment related TEAEs., Endoscopic remission defined as an ES ≤ 1 (excluding friability) at Week 12., MMS score at baseline and Week 12., Clinical response at Week 12 defined as: o decrease from baseline in the MMS of ≥ 2 points and at least a 30% reduction from baseline, and o decrease ≥ 1 point in RB from baseline or RB of ≤ 1, Histologic improvement (as defined in the Statistical Analysis Plan [SAP]) at Week 12. | — |
Countries
Bulgaria, Croatia, Greece, Hungary, Italy, Poland, Romania
Outcome results
None listed