Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

In plain English

What this trial is testing

This study is testing XmAb942 (a biologic) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 75
• Any sex
• Healthy volunteers accepted

Some of the main requirements, copied from the record:

• 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

Plus 9 more requirement(s). There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 270 participants are expected to take part.
• The study has 6 groups.
• Start date: 2024-10-10.
• Main results expected around 2027-12 (estimate from the record).
• 98 study sites listed (96 marked recruiting) in Argentina, Australia, Brazil, Bulgaria and Canada and 10 more countries.

Groups in this study

• Part A: Active drug (listed as: active comparator group)
• Part A: Placebo (listed as: placebo group)
• Part B: Active (listed as: active comparator group)
• Part B: Placebo (listed as: placebo group)
• Part C: Active (listed as: active comparator group)
• Part C: placebo (listed as: placebo group)

Main thing being measured

• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A) (20 weeks)
• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B) (28 weeks)
• Clinical remission based on modified mayo score (MMS), defined as MMS ≤ 2 with Mayo endoscopic score (MES) of 1, rectal bleeding subscore (RBS) of 0, and stool frequency subscore (SFS) of 0-1. (12 weeks)

In the researchers’ words

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).

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.