Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06619990

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Led by Xencor, Inc. · Updated on 2026-05-06

270

Participants Needed

57

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parts A and B: Age 18 to 55 years
  • Parts A and B: Must be in good health with no significant medical history
  • Parts A and B: Clinical laboratory values within normal range
  • Parts A and B: Body mass index (BMI) between 18 and 35 inclusive
  • Parts A and B: Use of contraception consistent with local regulations
  • Parts A and B: Able and willing to provide written informed consent
  • Part C: Age 18 to 75 years
  • Part C: Must be in good health with no significant medical history
  • Part C: Ulcerative colitis diagnosis at least 3 months prior to screening
  • Part C: Moderately to severely active ulcerative colitis defined by modified Mayo score ≥ 5, Mayo endoscopic score ≥ 2, and rectal bleeding subscore ≥ 1
  • Part C: Ulcerative colitis extending at least 15 cm from the anal verge confirmed by colonoscopy
  • Part C: Inadequate response, loss of response, or intolerance to at least one conventional or advanced therapy for ulcerative colitis
  • Part C: Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Parts A and B: Any physical or psychological condition that prevents study completion
  • Parts A and B: History of suicidal behavior or suicidal thoughts
  • Parts A and B: Heavy use of nicotine-containing products
  • Parts A and B: Positive for HIV, hepatitis B, or hepatitis C
  • Parts A and B: Cardiac arrhythmia or clinically significant abnormal ECG
  • Parts A and B: Active use of prescription medications within 14 days before Day -1
  • Parts A and B: Active use of over-the-counter or herbal medications within 7 days before screening
  • Parts A and B: Use of other investigational products within 30 days
  • Parts A and B: Blood or plasma donation within 60 days
  • Parts A and B: Pregnant or breastfeeding
  • Part C: Any physical or psychological condition that prevents study participation
  • Part C: Diagnosis of Crohn disease, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or diverticular disease with colitis
  • Part C: Positive test for Clostridium difficile toxins
  • Part C: Positive for HIV, hepatitis B, or hepatitis C
  • Part C: Cardiac arrhythmia or clinically significant abnormal ECG
  • Part C: Pregnant or breastfeeding
  • Other protocol defined inclusion/exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 57 locations

1

Xencor Investigative Site

Scottsdale, Arizona, United States, 85255

Actively Recruiting

2

Xencor Investigative Site

Bradenton, Florida, United States, 34209

Actively Recruiting

3

Xencor Investigative Site

Brandon, Florida, United States, 33511

Actively Recruiting

4

Xencor Investigative Site

Jacksonville, Florida, United States, 32258

Actively Recruiting

5

Xencor Investigative Site

Kissimmee, Florida, United States, 34741

Actively Recruiting

6

Xencor Investigative Site

Margate, Florida, United States, 33063

Actively Recruiting

7

Xencor Investigative Site

Palmetto Bay, Florida, United States, 33176

Actively Recruiting

8

Xencor Investigative Site

Tampa, Florida, United States, 33613

Actively Recruiting

9

Xencor Investigative Site

Louisville, Kentucky, United States, 40218

Actively Recruiting

10

Xencor Investigative Site

Raleigh, North Carolina, United States, 27612

Actively Recruiting

11

Xencor Investigative Site

Beavercreek, Ohio, United States, 45440

Actively Recruiting

12

Xencor Investigative Site

Denton, Texas, United States, 76201

Actively Recruiting

13

Xencor Investigative Site

Georgetown, Texas, United States, 78628

Actively Recruiting

14

Xencor Investigative Site

Houston, Texas, United States, 77024

Actively Recruiting

15

Xencor Investigative Site

Houston, Texas, United States, 77090

Actively Recruiting

16

Xencor Investigative Site

Kingwood, Texas, United States, 77339

Actively Recruiting

17

Xencor Investigative Site

Lubbock, Texas, United States, 79424

Actively Recruiting

18

Xencor Investigative Site

San Antonio, Texas, United States, 78229

Actively Recruiting

19

Xencor Investigative Site

Tyler, Texas, United States, 75701

Actively Recruiting

20

Xencor Investigative Site

Wollongong, New South Wales, Australia, 2500

Actively Recruiting

21

Xencor Investigative Site

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

22

Xencor Investigative Site

Southport, Queensland, Australia, 4215

Actively Recruiting

23

Xencor Investigative Site

Joondalup, Western Australia, Australia, 6027

Completed

24

Xencor Investigative Site

Nedlands, Western Australia, Australia, 6009

Completed

25

Xencor Investigative Site

Sofia, Bulgaria, 1618

Actively Recruiting

26

Xencor Investigative Site

Vancouver, British Columbia, Canada, V6Z 2K5

Actively Recruiting

27

Xencor Investigative Site

London, Ontario, Canada, N6K 1M5

Actively Recruiting

28

Xencor Investigative Site

Scarborough Village, Ontario, Canada, M1S4T7

Actively Recruiting

29

Xencor Investigative Site

Montreal, Quebec, Canada, H3H 1EB

Actively Recruiting

30

Xencor Investigative Site

Rijeka, Croatia, 51000

Actively Recruiting

31

Xencor Investigative Site

Zagreb, Croatia, 10000

Actively Recruiting

32

Xencor Investigative Site

Tbilisi, Georgia, 0112

Actively Recruiting

33

Xencor Investigative Site

Thessaloniki, Greece, 54642

Actively Recruiting

34

Xencor Investigative Site

Budapest, Hungary, 1136

Actively Recruiting

35

Xencor Investigative Site

Vác, Hungary, 2600

Actively Recruiting

36

Xencor Investigative Site

Chisinau, Moldova

Actively Recruiting

37

Xencor Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland, 53-611

Actively Recruiting

38

Xencor Investigative Site

Warsaw, Mazonian, Poland, 00-189

Actively Recruiting

39

Xencor Investigative Site

Sopot, Pomeranian Voivodeship, Poland, 81-756

Actively Recruiting

40

Xencor Investigative Site

Bydgoszcz, Poland, 85-079

Actively Recruiting

41

Xencor Investigative Site

Katowice, Poland, 40-748

Actively Recruiting

42

Xencor Investigative Site

Staszów, Poland, 28-200

Actively Recruiting

43

Xencor Investigative Site

Szczecin, Poland, 71-685

Actively Recruiting

44

Xencor Investigative Site

Warsaw, Poland, 004-501

Actively Recruiting

45

Xencor Investigative Site

Bucharest, District 1, Romania, 01-1658

Actively Recruiting

46

Xencor Investigative Site

Cluj-Napoca, Romania, 400006

Actively Recruiting

47

Xencor Investigative Site

Lutsk, Volyn Oblast, Ukraine, 43005

Actively Recruiting

48

Xencor Investigative Site

Ivano-Frankivsk, Ukraine, 76008

Actively Recruiting

49

Xencor Investigative Site

Kyiv, Ukraine, 01135

Actively Recruiting

50

Xencor Investigative Site

Kyiv, Ukraine, 02091

Actively Recruiting

51

Xencor Investigative Site

Lviv, Ukraine, 79000

Actively Recruiting

52

Xencor Investigative Site

Lviv, Ukraine, 79010

Actively Recruiting

53

Xencor Investigative Site

Lviv, Ukraine, 79059

Actively Recruiting

54

Xencor Investigative Site

Uzhhorod, Ukraine, 88000

Actively Recruiting

55

Xencor Investigative Site

Vinnytsia, Ukraine, 21009

Actively Recruiting

56

Xencor Investigative Site

Vinnytsia, Ukraine, 21028

Actively Recruiting

57

Xencor Investigative Site

Zhytomyr, Ukraine, 10001

Actively Recruiting

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Research Team

S

Sudeepta Aggarwal

CONTACT

M

Mark Osterman, MD, MSCE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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