Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Recruiting
Phase 1Phase 2Interventional Study
Ulcerative Colitis (UC)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
270 (estimated)
Sponsor
Xencor, Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Status
Eligibility Criteria
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 c…
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.
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