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XmAb942

Phase 1

Ulcerative Colitis (UC) | Monoclonal antibody | Gastrointestinal |Xencor, Inc.|Last Updated: Jul 24, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment270

FDA Designations

No designations recorded

Clinical trial landscape

XmAb942 · 1 trial · 1 indication

Phase 1 1
NCT06619990Study of XmAb942 in Healthy Participants and Participants With Ulcerative ColitisUlcerative Colitis (UC)
RECRUITING270 Analytics
PHASE1RECRUITING
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A)
20 weeks
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B)
28 weeks
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.
12 weeks

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.

Secondary Endpoints

Serum PK parameters of XmAb942 in Healthy Volunteers (Part A)
up to 20 weeks
Serum PK parameters of XmAb942 in Healthy Volunteers (Part B)
up to 28 weeks
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) (Part C)
72 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.
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.
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.
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.
Part C: ActiveACTIVE_COMPARATORActive XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis
Part C: placeboPLACEBO_COMPARATORPlacebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis

Interventions

NameTypeDescription
XmAb942BIOLOGICALAntibody
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites90

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 c...

Countries:United StatesArgentinaAustraliaBrazilBulgariaCanadaCroatiaGeorgiaGreeceHungaryMoldovaPolandPortugalRomaniaUkraine
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Recent Changes (Last 90 Days)

LOWJul 24, 2026NCT06619990lastUpdatePostDate: changed
LOWJul 24, 2026NCT06619990lastUpdatePostDate: changed
LOWJun 11, 2026NCT06619990lastUpdatePostDate: changed
LOWJun 11, 2026NCT06619990lastUpdatePostDate: changed

Frequently asked questions about XmAb942

What is XmAb942 used for?

XmAb942 is an investigational monoclonal antibody being developed for the treatment of Ulcerative Colitis (UC). It is currently in Phase 1 clinical development, with a study enrolling healthy participants and those with UC to evaluate its safety and efficacy.

Who makes XmAb942?

XmAb942 is being developed by Xencor, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XNCR. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy participants and individuals with Ulcerative Colitis.

What phase is XmAb942 in?

XmAb942 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 trial is currently recruiting participants to assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers and patients with Ulcerative Colitis.

What clinical trials is XmAb942 in?

XmAb942 is being studied in a single Phase 1 clinical trial with the identifier NCT06619990. This randomized, double-blind, placebo-controlled study is recruiting approximately 270 participants across multiple countries, including the United States, Argentina, Australia, Brazil, Bulgaria, Canada, and others.

Is XmAb942 the same as any other drug?

No alternative names for XmAb942 have been reported. The drug is identified solely by its code name XmAb942 in clinical trial registries and by its developer, Xencor, Inc. It is a distinct investigational monoclonal antibody being evaluated for Ulcerative Colitis.