XmAb942 for Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests XmAb942, a new treatment for ulcerative colitis (UC), a condition that inflames the colon. Initially, the study assesses the drug's safety and effects in healthy volunteers. It then evaluates the drug's effectiveness in individuals with moderate to severe UC who haven't responded well to other treatments. Participants must have had a UC diagnosis for at least 3 months and experience symptoms that impact daily life. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants the opportunity to be among the first to benefit from a potentially groundbreaking new therapy.
Do I need to stop taking my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications for Part C, which involves participants with ulcerative colitis. However, for Parts A and B, participants must not use prescription medications within 14 days before the trial starts.
Is there any evidence suggesting that XmAb942 is likely to be safe for humans?
Research has shown that XmAb942 is generally safe in early studies. A safety review from a previous study found that all doses and methods of administration were well tolerated, with no major safety issues reported. This suggests XmAb942 appears safe for those who have tried it so far. However, more research is needed to fully understand its safety for people with ulcerative colitis.12345
Why do researchers think this study treatment might be promising for ulcerative colitis?
Researchers are excited about XmAb942 for ulcerative colitis because it offers a new approach to treatment with its unique mechanism. Unlike current treatments like mesalamine, corticosteroids, or biologics that target inflammation broadly, XmAb942 is designed to specifically target and modulate certain immune pathways, potentially offering more precise control over the immune response. Additionally, XmAb942 can be administered both subcutaneously and intravenously, providing flexibility depending on the patient's needs. This targeted action and versatile administration method could lead to better outcomes with potentially fewer side effects.
What evidence suggests that XmAb942 might be an effective treatment for ulcerative colitis?
Research has shown that XmAb942, which participants in this trial may receive, targets TL1A, a protein linked to inflammation in ulcerative colitis. Early studies found that this treatment remains active in the body for over 71 days, allowing for less frequent dosing. In past human trials, XmAb942 was well tolerated, with participants experiencing few side effects. The treatment demonstrated significant effectiveness, suggesting it could help reduce inflammation in ulcerative colitis. These findings support the potential of XmAb942 as a promising treatment for managing ulcerative colitis symptoms.12367
Who Is on the Research Team?
Mark Osterman, MD, MSCE
Principal Investigator
Xencor, Inc.
Are You a Good Fit for This Trial?
This trial is for healthy adults with a BMI of 18-35 and those with ulcerative colitis. Participants must have normal lab values, be aged 18-55, and use contraception. It's not suitable for individuals with significant medical history or conditions that could interfere with the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part A: Single Ascending Dose (SAD)
Single administration of 3 ascending dose levels of XmAb942 or placebo in healthy volunteers
Part B: Multiple Ascending Dose (MAD)
Multiple administrations of 2 ascending dose levels of XmAb942 or placebo in healthy volunteers
Part C: Induction and Maintenance
Participants with UC receive XmAb942 or placebo during a 12-week induction period and a 40-week maintenance period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- XmAb942
Trial Overview
The study tests XmAb942 in two groups: healthy volunteers (Parts A & B) to assess safety and dosage, followed by people with ulcerative colitis (Part C) to evaluate its effectiveness in treating their condition compared to a placebo.
How Is the Trial Designed?
6
Treatment groups
Active Control
Placebo Group
Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
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.
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.
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.
Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
GALE Therapeutics Inc.
Lead Sponsor
Xencor, Inc.
Lead Sponsor
Citations
1.
xencor.com
xencor.com/wp-content/uploads/Interim-Results-from-First-in-Human-Study-of-XmAb942-TL1A-Pipeline-Update.pdfInterim Results from First-in-Human Study of XmAb942 & ...
2 Xencor-sponsored survey of 27 U.S.-based gastroenterologists covering treatment of >6000 patients with ulcerative colitis annually. Future of ...
2.
investors.xencor.com
investors.xencor.com/news-releases/news-release-details/xencor-announces-positive-interim-results-first-human-healthyXENITH-UC, a Phase 2b study of XmAb942 in ... - Investors
"Our Phase 1 data for XmAb942 validate our design goals for a best-in-class anti-TL1A therapy, combining high potency with less frequent dosing ...
NCT06619990 | Study of XmAb942 in Healthy Participants ...
Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy ...
P1097 Phase 1/2 study to assess safety, tolerability, and ...
P1097 Phase 1/2 study to assess safety, tolerability, and efficacy of XmAb942 (anti-TL1A) in healthy participants and participants with ...
August 6, 2025-- Xencor, Inc. (NASDAQ:XNCR), a clinical- ...
The results showed that XmAb942 was well tolerated at single and multiple doses and had a greater than 71-day half-life, which supports an every 12-week dosing ...
Study of XmAb942 in Healthy Participants and ...
Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy ...
Phase 1/2 Study to Assess Safety, Tolerability, and Efficacy of ...
Here, we present details of the ongoing seamless Phase 1/2 study (NCT06619990) assessing XmAb942 in healthy participants and participants with UC. Parts A and B.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.