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New antibody drug aims to tame ulcerative colitis

NCT ID NCT06619990

Disease control Sponsor: Xencor, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

This study tests a new antibody drug called XmAb942 for moderate-to-severe ulcerative colitis, a chronic inflammatory bowel disease. First, healthy volunteers will receive the drug to check safety. Then, about 270 people with ulcerative colitis will get either XmAb942 or a placebo to see if it can reduce symptoms and inflammation. The goal is to find a new treatment that helps patients achieve remission.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XmAb942 (an antibody)
What this could lead to
If successful, this could lead to a new treatment option for people with moderate-to-severe ulcerative colitis, potentially helping them achieve remission.
What could go wrong
This is an early trial (phase 1/2) with a small number of participants. The drug may not work as hoped, and side effects are unknown. It will take years before it might be available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Get notified about this study

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    96 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Xencor Investigative Site

    RECRUITING

    Scottsdale, Arizona, 85255, United States

  • Xencor Investigative Site

    RECRUITING

    Palo Alto, California, 94301, United States

  • Xencor Investigative Site

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Xencor Investigative Site

    RECRUITING

    Brandon, Florida, 33511, United States

  • Xencor Investigative Site

    RECRUITING

    Jacksonville, Florida, 32258, United States

  • Xencor Investigative Site

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Xencor Investigative Site

    RECRUITING

    Margate, Florida, 33063, United States

  • Xencor Investigative Site

    RECRUITING

    Palmetto Bay, Florida, 33176, United States

  • Xencor Investigative Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • Xencor Investigative Site

    RECRUITING

    Tampa, Florida, 33613, United States

  • Xencor Investigative Site

    RECRUITING

    Louisville, Kentucky, 40218, United States

  • Xencor Investigative Site

    RECRUITING

    Oxford, Mississippi, 38655, United States

  • Xencor Investigative Site

    RECRUITING

    Tupelo, Mississippi, 38801, United States

  • Xencor Investigative Site

    RECRUITING

    Albany, New York, 12206, United States

  • Xencor Investigative Site

    RECRUITING

    Rochester, New York, 14618, United States

  • Xencor Investigative Site

    RECRUITING

    Raleigh, North Carolina, 27612, United States

  • Xencor Investigative Site

    RECRUITING

    Beavercreek, Ohio, 45440, United States

  • Xencor Investigative Site

    RECRUITING

    Cordova, Tennessee, 38018, United States

  • Xencor Investigative Site

    RECRUITING

    Cedar Park, Texas, 78613, United States

  • Xencor Investigative Site

    RECRUITING

    Denton, Texas, 76201, United States

  • Xencor Investigative Site

    RECRUITING

    Garland, Texas, 75044, United States

  • Xencor Investigative Site

    RECRUITING

    Georgetown, Texas, 78628, United States

  • Xencor Investigative Site

    RECRUITING

    Houston, Texas, 77024, United States

  • Xencor Investigative Site

    RECRUITING

    Houston, Texas, 77090, United States

  • Xencor Investigative Site

    RECRUITING

    Kingwood, Texas, 77339, United States

  • Xencor Investigative Site

    RECRUITING

    Lubbock, Texas, 79424, United States

  • Xencor Investigative Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Xencor Investigative Site

    RECRUITING

    Tyler, Texas, 75701, United States

  • Xencor Investigative Site

    RECRUITING

    Webster, Texas, 77598, United States

  • Xencor Investigative Site

    RECRUITING

    Richmond, Virginia, 23229, United States

  • Xencor Investigative Site

    RECRUITING

    Buenos Aires, 1643, Argentina

  • Xencor Investigative Site

    RECRUITING

    Buenos Aires, B1878, Argentina

  • Xencor Investigative Site

    RECRUITING

    Buenos Aires, C425BGC, Argentina

  • Xencor Investigative Site

    RECRUITING

    Rosario, S2000, Argentina

  • Xencor Investigative Site

    RECRUITING

    San Miguel de Tucumán, 4000, Argentina

  • Xencor Investigative Site

    RECRUITING

    Adelaide, 5000, Australia

  • Xencor Investigative Site

    COMPLETED

    Joondalup, 6027, Australia

  • Xencor Investigative Site

    RECRUITING

    Melbourne, 3004, Australia

  • Xencor Investigative Site

    COMPLETED

    Nedlands, 6009, Australia

  • Xencor Investigative Site

    RECRUITING

    South Brisbane, 4101, Australia

  • Xencor Investigative Site

    RECRUITING

    Southport, 4215, Australia

  • Xencor Investigative Site

    RECRUITING

    Wollongong, 2500, Australia

  • Xencor Investigative Site

    RECRUITING

    Campinas, 13092-133, Brazil

  • Xencor Investigative Site

    RECRUITING

    Fortaleza, 60430-372, Brazil

  • Xencor Investigative Site

    RECRUITING

    Macaé, 27 910-190, Brazil

  • Xencor Investigative Site

    RECRUITING

    Porto Alegre, 90035-903, Brazil

  • Xencor Investigative Site

    RECRUITING

    Salvador, 41 820-020, Brazil

  • Xencor Investigative Site

    RECRUITING

    Santo André, 09080-110, Brazil

  • Xencor Investigative Site

    RECRUITING

    São Paulo, 01307-000, Brazil

  • Xencor Investigative Site

    RECRUITING

    São Paulo, 04543-011, Brazil

  • Xencor Investigative Site

    RECRUITING

    Votuporanga, 15500-269, Brazil

  • Xencor Investigative Site

    RECRUITING

    Sofia, 1618, Bulgaria

  • Xencor Investigative Site

    RECRUITING

    London, N6K 1M5, Canada

  • Xencor Investigative Site

    RECRUITING

    Montreal, H3H 1EB, Canada

  • Xencor Investigative Site

    RECRUITING

    Scarborough, M1S4T7, Canada

  • Xencor Investigative Site

    RECRUITING

    Vancouver, V6Z 2K5, Canada

  • Xencor Investigative Site

    RECRUITING

    Osijek, 31000, Croatia

  • Xencor Investigative Site

    RECRUITING

    Rijeka, 51000, Croatia

  • Xencor Investigative Site

    RECRUITING

    Zagreb, 10000, Croatia

  • Xencor Investigative Site

    RECRUITING

    Tbilisi, 0112, Georgia

  • Xencor Investigative Site

    RECRUITING

    Athens, 10676, Greece

  • Xencor Investigative Site

    RECRUITING

    Heraklion, 71500, Greece

  • Xencor Investigative Site

    RECRUITING

    Thessaloniki, 54642, Greece

  • Xencor Investigative Site

    RECRUITING

    Budapest, 1066, Hungary

  • Xencor Investigative Site

    RECRUITING

    Budapest, 1136, Hungary

  • Xencor Investigative Site

    RECRUITING

    Budapest, 1139, Hungary

  • Xencor Investigative Site

    RECRUITING

    Nyíregyháza, H-4405, Hungary

  • Xencor Investigative Site

    RECRUITING

    Vác, 2600, Hungary

  • Xencor Investigative Site

    RECRUITING

    Chisinau, Moldova

  • Xencor Investigative Site

    RECRUITING

    Bydgoszcz, 85-079, Poland

  • Xencor Investigative Site

    RECRUITING

    Katowice, 40-748, Poland

  • Xencor Investigative Site

    RECRUITING

    Krakow, 30-363, Poland

  • Xencor Investigative Site

    RECRUITING

    Nowy Targ, 34-400, Poland

  • Xencor Investigative Site

    RECRUITING

    Sopot, 81-756, Poland

  • Xencor Investigative Site

    RECRUITING

    Staszów, 28-200, Poland

  • Xencor Investigative Site

    RECRUITING

    Szczecin, 71-685, Poland

  • Xencor Investigative Site

    RECRUITING

    Warsaw, 00-189, Poland

  • Xencor Investigative Site

    RECRUITING

    Warsaw, 004-501, Poland

  • Xencor Investigative Site

    RECRUITING

    Warsaw, 03-580, Poland

  • Xencor Investigative Site

    RECRUITING

    Wroclaw, 52-416, Poland

  • Xencor Investigative Site

    RECRUITING

    Wroclaw, 53-611, Poland

  • Xencor Investigative Site

    RECRUITING

    Loures, 2674-514, Portugal

  • Xencor Investigative Site

    RECRUITING

    Bucharest, District 1, 01-1658, Romania

  • Xencor Investigative Site

    RECRUITING

    Bragadiru, 400006, Romania

  • Xencor Investigative Site

    RECRUITING

    Cluj-Napoca, 400006, Romania

  • Xencor Investigative Site

    RECRUITING

    Ploieşti, 100032, Romania

  • Xencor Investigative Site

    RECRUITING

    Timișoara, 300002, Romania

  • Xencor Investigative Site

    RECRUITING

    Ivano-Frankivsk, 76008, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Kyiv, 01135, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Kyiv, 02091, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Lutsk, 43005, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Lviv, 79000, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Lviv, 79010, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Lviv, 79059, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Uzhhorod, 88000, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Vinnytsia, 21009, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Vinnytsia, 21028, Ukraine

  • Xencor Investigative Site

    RECRUITING

    Zhytomyr, 10001, Ukraine

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