RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study in Participants With Moderate-To-Severe Active Ulcerative Colitis.
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form
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 willing to sign a consent form
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
XmAb942
Antibody
DRUG
Placebo
Placebo
Locations (20)
Xencor Investigative Site
Scottsdale, Arizona, United States
Xencor Investigative Site
Bradenton, Florida, United States
Xencor Investigative Site
Jacksonville, Florida, United States
Xencor Investigative Site
Kissimmee, Florida, United States
Xencor Investigative Site
Tampa, Florida, United States
Xencor Investigative Site
Raleigh, North Carolina, United States
Xencor Investigative Site
Denton, Texas, United States
Xencor Investigative Site
Houston, Texas, United States
Xencor Investigative Site
Kingwood, Texas, United States
Xencor Investigative Site
San Antonio, Texas, United States
Xencor Investigative Site
Wollongong, New South Wales, Australia
Xencor Investigative Site
South Brisbane, Queensland, Australia
Xencor Investigative Site
Joondalup, Western Australia, Australia
Xencor Investigative Site
Nedlands, Western Australia, Australia
Xencor Investigative Site
Sofia, Bulgaria
Xencor Investigative Site
Vancouver, British Columbia, Canada
Xencor Investigative Site
London, Ontario, Canada
Xencor Investigative Site
Scarborough Village, Ontario, Canada
Xencor Investigative Site
Zagreb, Croatia
Xencor Investigative Site
Tbilisi, Georgia