NCT06619990RecruitingPhase 1/2
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 of XmAb942 in Participants With Moderate-To-Severe Active Ulcerative Colitis.
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 20 Sept 2024
- Start date
- 10 Oct 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Xencor, Inc.
- Diseases
- Ulcerative colitis
- NCT number
- NCT06619990
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 270
- From 10 Oct 2024 to the primary completion date, 31 Dec 2027
- 94 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any physical or psychological condition that prohibits study completion
- History of suicidal behavior or suicidal ideation
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
- 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.
- HIV, hepatitis B and hepatitis C positive
- Cardiac arrhythmia, or clinically significant abnormal ECG
Other
- Parts A and B
- Heavy use of nicotine containing products
- Blood or plasma donation within 60 days
- Pregnant or breastfeeding
- Part C
- Positive screen for Clostridium difficile (C. Difficile) toxins
- Pregnant or breastfeeding
- Other protocol defined inclusion/exclusion criteria apply.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (94)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xencor Investigative Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Joondalup | Australia | Completed |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Macquarie Park | Australia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Nedlands | Australia | Completed |
| Xencor Investigative Site Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Wollongong | Australia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Caxias do Sul | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Fortaleza | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Macaé | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Santo André | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Votuporanga | Brazil | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Scarborough | Canada | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Osijek | Croatia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Rijeka | Croatia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Vác | Hungary | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Amman | Jordan | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Irbid | Jordan | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Beirut | Lebanon | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Tripoli | Lebanon | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Nowy Targ | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Sopot | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Staszów | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Loures | Portugal | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Bragadiru | Romania | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Ploieşti | Romania | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Timișoara | Romania | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Lutsk | Ukraine | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Lviv | Ukraine | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Zhytomyr | Ukraine | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Beavercreek | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Bradenton | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Brandon | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Cedar Park | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Cordova | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Denton | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Garland | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Georgetown | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Kingwood | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Kissimmee | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Lubbock | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Margate | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Oxford | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Palmetto Bay | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Tupelo | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| Xencor Investigative Site Coordinator of this site? Confirm its status | Webster | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.