Evaluating XmAb942 in Healthy Individuals and Those with Ulcerative Colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of XmAb942 through a three-part approach. The first two parts involve healthy volunteers receiving single and multiple doses of XmAb942 or a placebo. The third part focuses on participants with Ulcerative Colitis, who will receive the determined dose of XmAb942 or placebo based on the results from the healthy volunteer phases. The study is designed to assess both the drug's effects and its safety profile.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

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.

Where it's running

• Xencor Investigative Site
  Scottsdale, Arizona, United States Recruiting
• Xencor Investigative Site
  Palo Alto, California, United States Recruiting
• Xencor Investigative Site
  Bradenton, Florida, United States Recruiting
• Xencor Investigative Site
  Brandon, Florida, United States Recruiting
• Xencor Investigative Site
  Jacksonville, Florida, United States Recruiting
• Xencor Investigative Site
  Kissimmee, Florida, United States Recruiting

+64 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: 942 Study Information
• Email: Xenith-UCinfo@xencor.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.