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XmAb942 · 1 trial · 1 indication
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...
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XmAb942 is an investigational monoclonal antibody being developed for the treatment of Ulcerative Colitis (UC). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy participants and those with UC to evaluate its safety and efficacy.
XmAb942 targets TL1A, a protein involved in inflammatory pathways. By binding to TL1A, the antibody aims to modulate the immune response implicated in Ulcerative Colitis. This mechanism is being investigated in early-stage clinical trials to determine its therapeutic potential.
XmAb942 is being developed by Xencor, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XNCR. Xencor is conducting the clinical development program for this investigational antibody therapy.
XmAb942 is in Phase 1 clinical development. It is an investigational drug and has not yet received approval from the FDA or other regulatory bodies. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and pharmacokinetics.
XmAb942 is being evaluated in a single Phase 1 clinical trial registered as NCT06619990. This randomized, double-blind, placebo-controlled study is recruiting approximately 270 participants across multiple countries, including the United States, Argentina, Australia, Brazil, and several European nations. The trial enrolls healthy volunteers and individuals with Ulcerative Colitis.
No alternative names for XmAb942 have been disclosed. The drug is identified solely by its code name XmAb942 in clinical trial registrations and public information. It is a distinct investigational monoclonal antibody being developed by Xencor for Ulcerative Colitis.