RecruitingPhase 1Phase 2NCT06619990

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 in Participants With Moderate-To-Severe Active Ulcerative Colitis.

Sponsor

Xencor, Inc.

Enrollment

270 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis (UC)

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing XmAb942 — a new experimental drug designed to modulate the immune system — in both healthy volunteers and people with ulcerative colitis (UC), a chronic inflammatory bowel disease. Early phases assess safety and tolerability in healthy adults, while a later phase focuses on people with moderate to severe UC who haven't responded well to existing treatments. **You may be eligible if...** - Parts A and B (healthy volunteers): You are between 18 and 55, in good health, with a BMI of 18–35, and no significant medical history - Part C (UC patients): You are between 18 and 75, have had UC for at least 3 months, your disease is moderately to severely active (confirmed by a colonoscopy showing extensive inflammation), and you have had inadequate response to, or cannot tolerate, at least one existing therapy - All groups: You are willing to use contraception and provide written informed consent **You may NOT be eligible if...** - You have significant other health conditions - For UC patients: your disease does not meet the severity criteria or you have not tried any existing standard UC therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALXmAb942

Antibody

DRUGPlacebo

Placebo

Locations(52)

Xencor Investigative Site

Scottsdale, Arizona, United States

Xencor Investigative Site

Bradenton, Florida, United States

Xencor Investigative Site

Brandon, Florida, United States

Xencor Investigative Site

Jacksonville, Florida, United States

Xencor Investigative Site

Kissimmee, Florida, United States

Xencor Investigative Site

Margate, Florida, United States

Xencor Investigative Site

Palmetto Bay, Florida, United States

Xencor Investigative Site

Tampa, Florida, United States

Xencor Investigative Site

Louisville, Kentucky, United States

Xencor Investigative Site

Raleigh, North Carolina, United States

Xencor Investigative Site

Denton, Texas, United States

Xencor Investigative Site

Georgetown, Texas, United States

Xencor Investigative Site

Houston, Texas, United States

Xencor Investigative Site

Kingwood, Texas, United States

Xencor Investigative Site

San Antonio, Texas, United States

Xencor Investigative Site

Tyler, Texas, United States

Xencor Investigative Site

Wollongong, New South Wales, Australia

Xencor Investigative Site

South Brisbane, Queensland, Australia

Xencor Investigative Site

Southport, Queensland, Australia

Xencor Investigative Site

Joondalup, Western Australia, Australia

Xencor Investigative Site

Nedlands, Western Australia, Australia

Xencor Investigative Site

Sofia, Bulgaria

Xencor Investigative Site

Vancouver, British Columbia, Canada

Xencor Investigative Site

London, Ontario, Canada

Xencor Investigative Site

Scarborough Village, Ontario, Canada

Xencor Investigative Site

Rijeka, Croatia

Xencor Investigative Site

Zagreb, Croatia

Xencor Investigative Site

Tbilisi, Georgia

Xencor Investigative Site

Budapest, Hungary

Xencor Investigative Site

Vác, Hungary

Xencor Investigative Site

Chisinau, Moldova

Xencor Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

Xencor Investigative Site

Warsaw, Mazonian, Poland

Xencor Investigative Site

Sopot, Pomeranian Voivodeship, Poland

Xencor Investigative Site

Bydgoszcz, Poland

Xencor Investigative Site

Katowice, Poland

Xencor Investigative Site

Staszów, Poland

Xencor Investigative Site

Szczecin, Poland

Xencor Investigative Site

Warsaw, Poland

Xencor Investigative Site

Bucharest, District 1, Romania

Xencor Investigative Site

Cluj-Napoca, Romania

Xencor Investigative Site

Lutsk, Volyn Oblast, Ukraine

Xencor Investigative Site

Ivano-Frankivsk, Ukraine

Xencor Investigative Site

Kyiv, Ukraine

Xencor Investigative Site

Kyiv, Ukraine

Xencor Investigative Site

Lviv, Ukraine

Xencor Investigative Site

Lviv, Ukraine

Xencor Investigative Site

Lviv, Ukraine

Xencor Investigative Site

Uzhhorod, Ukraine

Xencor Investigative Site

Vinnytsia, Ukraine

Xencor Investigative Site

Vinnytsia, Ukraine

Xencor Investigative Site

Zhytomyr, Ukraine

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NCT06619990

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