NCT06619990

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study in Participants With Moderate-To-Severe Active Ulcerative Colitis.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).

Detailed description

This study consists of 3 parts, as follows: Part A: Single ascending dose (SAD) in healthy participants, will entail administration of XmAb942 or matching placebo at 3 different dose levels of XmAb942. Part B: Repeat dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo at 2 different dose levels of XmAb942. Part C: Participants with moderately to severely active UC to receive 3 different dose levels of XmAb942 or placebo during a 12-week induction period and single dose level of XmAb942 during a 40-week maintenance period, followed by a 24 week follow-up period.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
BIOLOGICAL	XmAb942	Antibody
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-10-10
• Primary completion: 2028-04-01
• Completion: 2029-01-01
• First posted: 2024-10-01
• Last updated: 2026-04-13

Locations

52 sites across 11 countries: United States, Australia, Bulgaria, Canada, Croatia, Georgia, Hungary, Moldova, Poland, Romania, Ukraine

Regulatory

• FDA-regulated drug study