What is XmAb942 studying for ulcerative colitis?

XmAb942 is being studied to evaluate its safety, how it works in the body, and its potential effects for people with ulcerative colitis. Researchers are comparing different doses of XmAb942 to placebo in both healthy volunteers and participants with active ulcerative colitis. The study is sponsored by Xencor, Inc. to better understand this treatment option.

Who may be eligible for this ulcerative colitis clinical trial?

Adults aged 18 to 75 with moderately to severely active ulcerative colitis may be eligible. Healthy adults aged 18 to 55 can also participate in earlier study parts. Key requirements include a confirmed diagnosis of ulcerative colitis for at least 3 months and prior inadequate response to UC therapies. Please review eligibility criteria for more details.

Is there any cost to participate in this ulcerative colitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participating may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

Healthy Volunteers

ID06619990

Phase 1 and 2 Study of XmAb942 for Healthy Adults and Adults With Moderate to Severe Ulcerative Colitis

Led by Xencor, Inc. · Updated on 2026-07-24

270

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effects of XmAb942 in healthy volunteers and participants with moderately to severely active ulcerative colitis UC. This combined Phase 1 and Phase 2 study involves healthy adults and UC patients to assess different dose levels of XmAb942 compared with placebo. The study aims to understand how the drug behaves in the body and its potential effects on UC symptoms and disease activity. The study has three parts Part A tests single ascending doses of XmAb942 or placebo in healthy volunteers via subcutaneous or intravenous administration. Part B involves multiple ascending doses in healthy volunteers via intravenous administration. Part C includes participants with active UC receiving different doses of XmAb942 or placebo during a 12-week induction phase, followed by a 40-week maintenance dose and a 24-week follow-up period. Participants will undergo various assessments including safety monitoring for adverse events, blood tests to measure drug levels, and clinical evaluations of UC activity using scores such as the modified Mayo score and endoscopic assessments. The trial includes regular visits during dosing and follow-up periods to track effects and safety over up to 72 weeks for UC participants. Healthy volunteers are monitored for up to 28 weeks following dosing in Parts A and B.

CONDITIONS

Brief Title

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Who Can Participate

Age: 18Years - 75Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

For Parts A and B: Age 18 to 55 years
For Parts A and B: Must be in good health with no significant medical history
For Parts A and B: Clinical laboratory values within normal range
For Parts A and B: Body mass index (BMI) between 18 and 35 inclusive
For Parts A and B: Use of contraceptives consistent with local regulations
For Parts A and B: Able and willing to provide written informed consent
For Part C: Age 18 to 75 years
For Part C: Must be in good health with no significant medical history
For Part C: Diagnosed with ulcerative colitis for at least 3 months prior to screening
For Part C: Moderately to severely active ulcerative colitis with modified Mayo score (MMS) ≥ 5, Mayo endoscopic score (MES) ≥ 2, and rectal bleeding subscore (RBS) ≥ 1
For Part C: Ulcerative colitis extending at least 15 cm from the anal verge as shown by colonoscopy
For Part C: Inadequate response, loss of response, or intolerance to at least one conventional or advanced ulcerative colitis therapy
For Part C: Able and willing to provide written informed consent

You will not qualify if you...

For Parts A and B: Any physical or psychological condition that prevents study completion
For Parts A and B: History of suicidal behavior or suicidal ideation
For Parts A and B: Heavy use of nicotine-containing products
For Parts A and B: Positive for HIV, hepatitis B, or hepatitis C
For Parts A and B: Cardiac arrhythmia or clinically significant abnormal ECG
For Parts A and B: Use of prescription medications within 14 days before Day -1
For Parts A and B: Use of over-the-counter or herbal medications within 7 days before screening
For Parts A and B: Use of other investigational products within 30 days
For Parts A and B: Blood or plasma donation within 60 days
For Parts A and B: Pregnant or breastfeeding
For Part C: Any physical or psychological condition that prevents study participation
For Part C: Diagnosed with Crohn disease, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or diverticular disease with colitis
For Part C: Positive test for Clostridium difficile toxins
For Part C: Positive for HIV, hepatitis B, or hepatitis C
For Part C: Cardiac arrhythmia or clinically significant abnormal ECG
For Part C: Pregnant or breastfeeding
Other protocol-defined inclusion and exclusion criteria apply

Research Team

942 Study Information

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Phase 1 and 2 Study of XmAb942 for Healthy Adults and Adults With Moderate to Severe Ulcerative Colitis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria