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NCT06619990PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Xencor, Inc.

Start Date

10/10/2024

Completion Date

1/1/2029

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).

Detailed Description

This study consists of 3 parts, as follows: Part A: Single ascending dose (SAD) in healthy 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 24 week follow-up period.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

BIOLOGICAL

XmAb942

DRUG

Placebo

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Conditions

Ulcerative Colitis (UC)

Locations

Xencor Investigative Site

Scottsdale, Arizona 85255

United States

Xencor Investigative Site

Bradenton, Florida 34209

United States

Xencor Investigative Site

Brandon, Florida 33511

United States

Xencor Investigative Site

Jacksonville, Florida 32258

United States

Xencor Investigative Site

Kissimmee, Florida 34741

United States

Xencor Investigative Site

Margate, Florida 33063

United States

Xencor Investigative Site

Palmetto Bay, Florida 33176

United States

Xencor Investigative Site

Tampa, Florida 33612

United States

Xencor Investigative Site

Tampa, Florida 33613

United States

Xencor Investigative Site

Louisville, Kentucky 40218

United States

Xencor Investigative Site

Oxford, Mississippi 38655

United States

Xencor Investigative Site

Tupelo, Mississippi 38801

United States

Xencor Investigative Site

Albany, New York 12206

United States

Xencor Investigative Site

Rochester, New York 14618

United States

Xencor Investigative Site

Raleigh, North Carolina 27612

United States

Xencor Investigative Site

Beavercreek, Ohio 45440

United States

Xencor Investigative Site

Cordova, Tennessee 38018

United States

Xencor Investigative Site

Cedar Park, Texas 78613

United States

Xencor Investigative Site

Denton, Texas 76201

United States

Xencor Investigative Site

Garland, Texas 75044

United States

Xencor Investigative Site

Georgetown, Texas 78628

United States

Xencor Investigative Site

Houston, Texas 77024

United States

Xencor Investigative Site

Houston, Texas 77090

United States

Xencor Investigative Site

Kingwood, Texas 77339

United States

Xencor Investigative Site

Lubbock, Texas 79424

United States

Xencor Investigative Site

San Antonio, Texas 78229

United States

Xencor Investigative Site

Tyler, Texas 75701

United States

Xencor Investigative Site

Webster, Texas 77598

United States

Xencor Investigative Site

Richmond, Virginia 23229

United States

Xencor Investigative Site

Buenos Aires, C425BGC

Argentina

Xencor Investigative Site

Rosario, S2000

Argentina

Xencor Investigative Site

San Miguel de Tucumán, 4000

Argentina

Xencor Investigative Site

Adelaide, 5000

Australia

Xencor Investigative Site

Joondalup, 6027

Australia

Xencor Investigative Site

Melbourne, 3004

Australia

Xencor Investigative Site

Nedlands, 6009

Australia

Xencor Investigative Site

South Brisbane, 4101

Australia

Xencor Investigative Site

Southport, 4215

Australia

Xencor Investigative Site

Wollongong, 2500

Australia

Xencor Investigative Site

Campinas, 13092-133

Brazil

Xencor Investigative Site

Porto Alegre, 90035-903

Brazil

Xencor Investigative Site

Santo André, 09080-110

Brazil

Xencor Investigative Site

São Paulo, 04543-011

Brazil

Xencor Investigative Site

Votuporanga, 15500-269

Brazil

Xencor Investigative Site

Sofia, 1618

Bulgaria

Xencor Investigative Site

London, N6K 1M5

Canada

Xencor Investigative Site

Montreal, H3H 1EB

Canada

Xencor Investigative Site

Scarborough, M1S4T7

Canada

Xencor Investigative Site

Vancouver, V6Z 2K5

Canada

Xencor Investigative Site

Osijek, 31000

Croatia

Xencor Investigative Site

Rijeka, 51000

Croatia

Xencor Investigative Site

Zagreb, 10000

Croatia

Xencor Investigative Site

Tbilisi, 0112

Georgia

Xencor Investigative Site

Athens, 10676

Greece

Xencor Investigative Site

Heraklion, 71500

Greece

Xencor Investigative Site

Thessaloniki, 54642

Greece

Xencor Investigative Site

Budapest, 1066

Hungary

Xencor Investigative Site

Budapest, 1136

Hungary

Xencor Investigative Site

Budapest, 1139

Hungary

Xencor Investigative Site

Nyíregyháza, H-4405

Hungary

Xencor Investigative Site

Vác, 2600

Hungary

Xencor Investigative Site

Chisinau,

Moldova

Xencor Investigative Site

Bydgoszcz, 85-079

Poland

Xencor Investigative Site

Katowice, 40-748

Poland

Xencor Investigative Site

Krakow, 30-363

Poland

Xencor Investigative Site

Nowy Targ, 34-400

Poland

Xencor Investigative Site

Sopot, 81-756

Poland

Xencor Investigative Site

Staszów, 28-200

Poland

Xencor Investigative Site

Szczecin, 71-685

Poland

Xencor Investigative Site

Warsaw, 00-189

Poland

Xencor Investigative Site

Warsaw, 004-501

Poland

Xencor Investigative Site

Warsaw, 03-580

Poland

Xencor Investigative Site

Wroclaw, 52-416

Poland

Xencor Investigative Site

Wroclaw, 53-611

Poland

Xencor Investigative Site

Loures, 2674-514

Portugal

Xencor Investigative Site

Bucharest, District 1 01-1658

Romania

Xencor Investigative Site

Cluj-Napoca, 400006

Romania

Xencor Investigative Site

Ploieşti, 100032

Romania

Xencor Investigative Site

Timișoara, 300002

Romania

Xencor Investigative Site

Ivano-Frankivsk, 76008

Ukraine

Xencor Investigative Site

Kyiv, 01135

Ukraine

Xencor Investigative Site

Kyiv, 02091

Ukraine

Xencor Investigative Site

Lutsk, 43005

Ukraine

Xencor Investigative Site

Lviv, 79000

Ukraine

Xencor Investigative Site

Lviv, 79010

Ukraine

Xencor Investigative Site

Lviv, 79059

Ukraine

Xencor Investigative Site

Uzhhorod, 88000

Ukraine

Xencor Investigative Site

Vinnytsia, 21009

Ukraine

Xencor Investigative Site

Vinnytsia, 21028

Ukraine

Xencor Investigative Site

Zhytomyr, 10001

Ukraine