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New treatment option for Ulcerative Colitis (UC)
Official title Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
ClinicalTrials.gov ID: NCT06619990
What this study is testing
What is XmAb942?
XmAb942 is an investigational medicine, being studied as a potential treatment for ulcerative colitis (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- Parts A and B
- Any physical or psychological condition that prohibits study completion
- History of suicidal behavior or suicidal ideation
- Heavy use of nicotine containing products
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
See the full eligibility 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 consent Part C
- Age 18-75
- Must be in good health with no significant medical history
- UC diagnosis ≥ 3 months prior to screening
- Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1
- Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy
- Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies of UC
- Able and willing to provide written informed consent
- Parts A and B
- Any physical or psychological condition that prohibits study completion
- History of suicidal behavior or suicidal ideation
- Heavy use of nicotine containing products
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
- Active use of prescription medications within 14 days of Day -1
- Active use of over-the-counter, or herbal medication within 7 days of Screening
- Other investigational products within 30 days
- Blood or plasma donation within 60 days
- Pregnant or breastfeeding Part C
- Any physical or psychological condition that prohibits study participation
- Diagnosis of Crohn disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.
- Positive screen for Clostridium difficile (C. Difficile) toxins
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
- Pregnant or breastfeeding Other protocol defined inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Bradenton, Florida, United States
- Brandon, Florida, United States
- Jacksonville, Florida, United States
- Kissimmee, Florida, United States
- Margate, Florida, United States
- Palmetto Bay, Florida, United States
- Tampa, Florida, United States
- Louisville, Kentucky, United States
- Albany, New York, United States
- Rochester, New York, United States
- Raleigh, North Carolina, United States
- Beavercreek, Ohio, United States
- Cedar Park, Texas, United States
- Denton, Texas, United States
- Georgetown, Texas, United States
- Houston, Texas, United States
- Kingwood, Texas, United States
- Lubbock, Texas, United States
- San Antonio, Texas, United States
+ 40 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Bradenton, Florida, United States; Brandon, Florida, United States; Jacksonville, Florida, United States; Kissimmee, Florida, United States; Margate, Florida, United States and 54 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.