Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06619990 | Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis | PHASE1 | RECRUITING | 270 | — | — | Oct 10, 2024 | Jan 1, 2029 | May 6, 2026 | 57 | United States, Australia +10 |
A composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. It is calculated by adding the results from Mayo endoscopic subscore (MES) which measures GI bleeding, stool frequency subscore (SFS) which measures stool frequency per day, and rectal bleeding subscore (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.
| Arm | Type | Description |
|---|---|---|
| Part A: Active drug | ACTIVE_COMPARATOR | Active XmAb942 to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels of XmAb942 via SC (3 cohorts) or IV (3 cohorts) administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo. |
| Part A: Placebo | PLACEBO_COMPARATOR | Placebo Comparator to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels will be randomized in a 3:1 ratio to active or placebo. |
| Part B: Active | ACTIVE_COMPARATOR | Active XmAb942 to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels of XmAb942 via IV administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo. |
| Part B: Placebo | PLACEBO_COMPARATOR | Placebo Comparator to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels will be randomized in a 3:1 ratio to active or placebo. |
| Part C: Active | ACTIVE_COMPARATOR | Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis |
| Part C: placebo | PLACEBO_COMPARATOR | Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis |
| Name | Type | Description |
|---|---|---|
| XmAb942 | BIOLOGICAL | Antibody |
| Placebo | DRUG | Placebo |
Inclusion Criteria: Parts A and B * Age 18-55 * Must be in good health with no significant medical history * Clinical laboratory values within normal range * BMI 18-35 (inclusive) * Contraceptive use by men or women consistent with local regulations * Able and willing to provide written informed c...