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Ulcerative Colitis (UC)Phase 1/2NCT06619990

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

A Phase 1/2 study testing XmAb942 in people with Ulcerative Colitis (UC), run by Xencor, Inc. at 114 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
XmAb942
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
114 sitesin 19 countries
Study dates
10 Oct 2024to May 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

114 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

942 Study Information contact

Xenith-UCinfo@xencor.com

114 sites in 19 countries

United States31 sites, 31 recruiting

  • Xencor Investigative Site

    Albany, New York, 12206

    Recruiting

  • Xencor Investigative Site

    Beavercreek, Ohio, 45440

    Recruiting

  • Xencor Investigative Site

    Bradenton, Florida, 34209

    Recruiting

  • Xencor Investigative Site

    Brandon, Florida, 33511

    Recruiting

  • Xencor Investigative Site

    Cedar Park, Texas, 78613

    Recruiting

  • Xencor Investigative Site

    Cordova, Tennessee, 38018

    Recruiting

  • Xencor Investigative Site

    Denton, Texas, 76201

    Recruiting

  • Xencor Investigative Site

    Garland, Texas, 75044

    Recruiting

  • Xencor Investigative Site

    Georgetown, Texas, 78628

    Recruiting

  • Xencor Investigative Site

    Houston, Texas, 77024

    Recruiting

  • Xencor Investigative Site

    Houston, Texas, 77090

    Recruiting

  • Xencor Investigative Site

    Jacksonville, Florida, 32258

    Recruiting

  • Xencor Investigative Site

    Kingwood, Texas, 77339

    Recruiting

  • Xencor Investigative Site

    Kissimmee, Florida, 34741

    Recruiting

  • Xencor Investigative Site

    Louisville, Kentucky, 40218

    Recruiting

  • Xencor Investigative Site

    Lubbock, Texas, 79424

    Recruiting

  • Xencor Investigative Site

    Margate, Florida, 33063

    Recruiting

  • Xencor Investigative Site

    Oxford, Mississippi, 38655

    Recruiting

  • Xencor Investigative Site

    Palmetto Bay, Florida, 33176

    Recruiting

  • Xencor Investigative Site

    Palo Alto, California, 94301

    Recruiting

  • Xencor Investigative Site

    Raleigh, North Carolina, 27612

    Recruiting

  • Xencor Investigative Site

    Richmond, Virginia, 23229

    Recruiting

  • Xencor Investigative Site

    Rochester, New York, 14618

    Recruiting

  • Xencor Investigative Site

    San Antonio, Texas, 78229

    Recruiting

  • Xencor Investigative Site

    Scottsdale, Arizona, 85255

    Recruiting

  • Xencor Investigative Site

    Tampa, Florida, 33612

    Recruiting

  • Xencor Investigative Site

    Tampa, Florida, 33613

    Recruiting

  • Xencor Investigative Site

    Tampa, Florida, 33615

    Recruiting

  • Xencor Investigative Site

    Tupelo, Mississippi, 38801

    Recruiting

  • Xencor Investigative Site

    Tyler, Texas, 75701

    Recruiting

  • Xencor Investigative Site

    Webster, Texas, 77598

    Recruiting

Other trials in United States

Poland12 sites, 12 recruiting

  • Xencor Investigative Site

    Bydgoszcz, 85-079

    Recruiting

  • Xencor Investigative Site

    Katowice, 40-748

    Recruiting

  • Xencor Investigative Site

    Krakow, 30-363

    Recruiting

  • Xencor Investigative Site

    Nowy Targ, 34-400

    Recruiting

  • Xencor Investigative Site

    Sopot, 81-756

    Recruiting

  • Xencor Investigative Site

    Staszów, 28-200

    Recruiting

  • Xencor Investigative Site

    Szczecin, 71-685

    Recruiting

  • Xencor Investigative Site

    Warsaw, 00-189

    Recruiting

  • Xencor Investigative Site

    Warsaw, 004-501

    Recruiting

  • Xencor Investigative Site

    Warsaw, 03-580

    Recruiting

  • Xencor Investigative Site

    Wroclaw, 52-416

    Recruiting

  • Xencor Investigative Site

    Wroclaw, 53-611

    Recruiting

Other trials in Poland

Ukraine11 sites, 11 recruiting

  • Xencor Investigative Site

    Ivano-Frankivsk, 76008

    Recruiting

  • Xencor Investigative Site

    Kyiv, 01135

    Recruiting

  • Xencor Investigative Site

    Kyiv, 02091

    Recruiting

  • Xencor Investigative Site

    Lutsk, 43005

    Recruiting

  • Xencor Investigative Site

    Lviv, 79000

    Recruiting

  • Xencor Investigative Site

    Lviv, 79010

    Recruiting

  • Xencor Investigative Site

    Lviv, 79059

    Recruiting

  • Xencor Investigative Site

    Uzhhorod, 88000

    Recruiting

  • Xencor Investigative Site

    Vinnytsia, 21009

    Recruiting

  • Xencor Investigative Site

    Vinnytsia, 21028

    Recruiting

  • Xencor Investigative Site

    Zhytomyr, 10001

    Recruiting

Other trials in Ukraine

Brazil10 sites, 10 recruiting

  • Xencor Investigative Site

    Campinas, 13092-133

    Recruiting

  • Xencor Investigative Site

    Caxias do Sul, 95070-560

    Recruiting

  • Xencor Investigative Site

    Fortaleza, 60430-372

    Recruiting

  • Xencor Investigative Site

    Macaé, 27 910-190

    Recruiting

  • Xencor Investigative Site

    Porto Alegre, 90035-903

    Recruiting

  • Xencor Investigative Site

    Salvador, 41 820-020

    Recruiting

  • Xencor Investigative Site

    Santo André, 09080-110

    Recruiting

  • Xencor Investigative Site

    São Paulo, 01307-000

    Recruiting

  • Xencor Investigative Site

    São Paulo, 04543-011

    Recruiting

  • Xencor Investigative Site

    Votuporanga, 15500-269

    Recruiting

Other trials in Brazil

Australia9 sites, 7 recruiting

  • Xencor Investigative Site

    Adelaide, 5000

    Recruiting

  • Xencor Investigative Site

    Brisbane, 4102

    Recruiting

  • Xencor Investigative Site

    Joondalup, 6027

    Completed

  • Xencor Investigative Site

    Macquarie Park, 2019

    Recruiting

  • Xencor Investigative Site

    Melbourne, 3004

    Recruiting

  • Xencor Investigative Site

    Nedlands, 6009

    Completed

  • Xencor Investigative Site

    South Brisbane, 4101

    Recruiting

  • Xencor Investigative Site

    Southport, 4215

    Recruiting

  • Xencor Investigative Site

    Wollongong, 2500

    Recruiting

Other trials in Australia

Romania7 sites, 7 recruiting

  • Xencor Investigative Site

    Bragadiru, 400006

    Recruiting

  • Xencor Investigative Site

    Bucharest, District 1, 01-1658

    Recruiting

  • Xencor Investigative Site

    Bucharest, 020125

    Recruiting

  • Xencor Investigative Site

    Bucharest, 021967

    Recruiting

  • Xencor Investigative Site

    Cluj-Napoca, 400006

    Recruiting

  • Xencor Investigative Site

    Ploieşti, 100032

    Recruiting

  • Xencor Investigative Site

    Timișoara, 300002

    Recruiting

Other trials in Romania

Argentina5 sites, 5 recruiting

  • Xencor Investigative Site

    Buenos Aires, 1643

    Recruiting

  • Xencor Investigative Site

    Buenos Aires, B1878

    Recruiting

  • Xencor Investigative Site

    Buenos Aires, C425BGC

    Recruiting

  • Xencor Investigative Site

    Rosario, S2000

    Recruiting

  • Xencor Investigative Site

    San Miguel de Tucumán, 4000

    Recruiting

Other trials in Argentina

Hungary5 sites, 5 recruiting

  • Xencor Investigative Site

    Budapest, 1066

    Recruiting

  • Xencor Investigative Site

    Budapest, 1136

    Recruiting

  • Xencor Investigative Site

    Budapest, 1139

    Recruiting

  • Xencor Investigative Site

    Nyíregyháza, H-4405

    Recruiting

  • Xencor Investigative Site

    Vác, 2600

    Recruiting

Other trials in Hungary

Canada4 sites, 4 recruiting

  • Xencor Investigative Site

    London, N6K 1M5

    Recruiting

  • Xencor Investigative Site

    Montreal, H3H 1EB

    Recruiting

  • Xencor Investigative Site

    Scarborough, M1S4T7

    Recruiting

  • Xencor Investigative Site

    Vancouver, V6Z 2K5

    Recruiting

Other trials in Canada

Lebanon4 sites, 4 recruiting

  • Xencor Investigative Site

    Beirut, 0295

    Recruiting

  • Xencor Investigative Site

    Beirut, 1100-2807

    Recruiting

  • Xencor Investigative Site

    Beirut, 1100

    Recruiting

  • Xencor Investigative Site

    Tripoli, 1434

    Recruiting

Other trials in Lebanon

Croatia3 sites, 3 recruiting

  • Xencor Investigative Site

    Osijek, 31000

    Recruiting

  • Xencor Investigative Site

    Rijeka, 51000

    Recruiting

  • Xencor Investigative Site

    Zagreb, 10000

    Recruiting

Other trials in Croatia

Greece3 sites, 3 recruiting

  • Xencor Investigative Site

    Athens, 10676

    Recruiting

  • Xencor Investigative Site

    Heraklion, 71500

    Recruiting

  • Xencor Investigative Site

    Thessaloniki, 54642

    Recruiting

Other trials in Greece

Jordan3 sites, 3 recruiting

  • Xencor Investigative Site

    Amman, 11196

    Recruiting

  • Xencor Investigative Site

    Amman, 11942

    Recruiting

  • Xencor Investigative Site

    Irbid, 21110

    Recruiting

Other trials in Jordan

Spain2 sites, 2 recruiting

  • Xencor Investigative Site

    Barcelona, 08022

    Recruiting

  • Xencor Investigative Site

    Valencia, 46026

    Recruiting

Other trials in Spain

Bulgaria1 site, 1 recruiting

  • Xencor Investigative Site

    Sofia, 1618

    Recruiting

Other trials in Bulgaria

Chile1 site, 1 recruiting

  • Xencor Investigative Site

    Santiago, 8320000

    Recruiting

Other trials in Chile

Georgia1 site, 1 recruiting

  • Xencor Investigative Site

    Tbilisi, 0112

    Recruiting

Other trials in Georgia

Moldova1 site, 1 recruiting

  • Xencor Investigative Site

    Chisinau

    Recruiting

Other trials in Moldova

Portugal1 site, 1 recruiting

  • Xencor Investigative Site

    Loures, 2674-514

    Recruiting

Other trials in Portugal

About this study

Official title: 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.

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).

Read the detailed description

This study consists of 3 parts, as follows:

Part A: Single ascending dose (SAD) in healthy volunteer participants, will entail administration of XmAb942 or matching placebo at 3 different dose levels of XmAb942.

Part B: Multiple ascending dosing for up to 3 doses, will entail administration of XmAb942 or matching placebo at 2 different dose levels of XmAb942.

Part C: Participants with moderately to severely active UC to receive 3 different dose levels of XmAb942 or placebo during a 12-week induction period and single dose level of XmAb942 during a 40-week maintenance period, followed by a 36 follow-up period.

Being tested
XmAb942, Placebo
Keywords
Ulcerative Colitis, Inflammatory Bowel Disease, Healthy Volunteers
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XmAb942Biological

    Antibody

  • PlaceboDrug

    Placebo

Study groups in NCT06619990
Study groupRoleWhat they receive
Part A: Active drugActive comparatorActive XmAb942 to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels of XmAb942 via SC (3 cohorts) or IV (3 cohorts) administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.
Receives: Biological: XmAb942
Part A: PlaceboPlacebo comparatorPlacebo Comparator to be administered to healthy volunteers. Single administration of 3 ascending dose (SAD) levels will be randomized in a 3:1 ratio to active or placebo.
Receives: Drug: Placebo
Part B: ActiveActive comparatorActive XmAb942 to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels of XmAb942 via IV administration in 8 participants per cohort, randomized in a 3:1 ratio to active or placebo.
Receives: Biological: XmAb942
Part B: PlaceboPlacebo comparatorPlacebo Comparator to be administered to healthy volunteers. Multiple administrations of 2 ascending dose (MAD) levels will be randomized in a 3:1 ratio to active or placebo.
Receives: Drug: Placebo
Part C: ActiveActive comparatorActive XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
Receives: Biological: XmAb942
Part C: placeboPlacebo comparatorPlacebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A)

    Measured: 20 weeks

  2. Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B)

    Measured: 28 weeks

  3. Clinical remission based on modified mayo score (MMS), defined as MMS ≤ 2 with Mayo endoscopic score (MES) of 1, rectal bleeding subscore (RBS) of 0, and stool frequency subscore (SFS) of 0-1.

    A composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9. It is calculated by adding the results from Mayo endoscopic subscore (MES) which measures GI bleeding, stool frequency subscore (SFS) which measures stool frequency per day, and rectal bleeding subscore (RBS), which measures presence of blood during stool passing. Each subscore is a scale of increasing severity from 0 to 3.

    Measured: 12 weeks

Secondary outcomes (10)

  1. Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)

    • Cmax (Maximum concentration of drug)

    Measured: up to 20 weeks

  2. Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)

    • AUC0-last (Area under the curve drug concentration-time curve to last concentration)

    Measured: up to 20 weeks

  3. Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)

    • Cmax (Maximum concentration of drug)

    Measured: up to 28 weeks

  4. Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)

    • AUC0-tau AUC within a dosing interval, calculated using the linear trapezoidal rule

    Measured: up to 28 weeks

  5. Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) (Part C)

    Measured: 72 weeks

  6. Discontinuations due to TEAEs (Part C)

    Measured: 72 weeks

  7. Endoscopic improvement defined as (MES) of 0 or 1 (Part C).

    Measured: 12 weeks

  8. Change from baseline in MS (Part C).

    Measured: 12 weeks

  9. Clinical response based on MMS score (Part C) defined as decrease from baseline in the MMS of ≥ 2 points and at least a 30% reduction from baseline, and decrease of ≥ 1 point in RBS from baseline or absolute RBS ≤ 1

    Measured: 12 weeks

  10. Histological improvement as determined by change in Robarts Histopathology Index (RHI) scores, ranging from 0 (no disease activity) to 33 (severe disease activity).

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start10 Oct 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619990
Sponsor's protocol ID
XmAb942-01 (G942-101)
Status last verified
Oct 2026
First submitted
20 Sep 2024
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XmAb942 in people with Ulcerative Colitis (UC), run by Xencor, Inc. at 114 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Poland, Ukraine, Brazil, Australia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact 942 Study Information (Xenith-UCinfo@xencor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A) (time frame: 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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