Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

NCT06619990 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: XmAb942-01 (G942-101)
• Study Type: interventional
• Target: 270
• Locations: 12 countries
• Sites: 57

Brief 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).

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis; Inflammatory Bowel Disease; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  12 weeks

Secondary Outcomes (10)

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

  up to 20 weeks

• 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

• 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

Study Arms (6)

Part A: Active drug

ACTIVE COMPARATOR

Active 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.

Biological: XmAb942

Part A: Placebo

PLACEBO COMPARATOR

Placebo 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.

Drug: Placebo

Part B: Active

ACTIVE COMPARATOR

Active 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.

Biological: XmAb942

Part B: Placebo

PLACEBO COMPARATOR

Placebo 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.

Drug: Placebo

Part C: Active

ACTIVE COMPARATOR

Active XmAb942 to be administered to participants with moderately to severely active Ulcerative Colitis

Biological: XmAb942

Part C: placebo

PLACEBO COMPARATOR

Placebo comparator to be administered to participants with moderately to severely active Ulcerative Colitis

Drug: Placebo

Interventions

XmAb942 BIOLOGICAL

Antibody

Part A: Active drug; Part B: Active; Part C: Active

Placebo DRUG

Placebo

Part A: Placebo; Part B: Placebo; Part C: placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (57)

Xencor Investigative Site

Scottsdale, Arizona, 85255, United States

RECRUITING

Xencor Investigative Site

Bradenton, Florida, 34209, United States

RECRUITING

Xencor Investigative Site

Brandon, Florida, 33511, United States

RECRUITING

Xencor Investigative Site

Jacksonville, Florida, 32258, United States

RECRUITING

Xencor Investigative Site

Kissimmee, Florida, 34741, United States

RECRUITING

Xencor Investigative Site

Margate, Florida, 33063, United States

RECRUITING

Xencor Investigative Site

Palmetto Bay, Florida, 33176, United States

RECRUITING

Xencor Investigative Site

Tampa, Florida, 33613, United States

RECRUITING

Xencor Investigative Site

Louisville, Kentucky, 40218, United States

RECRUITING

Xencor Investigative Site

Raleigh, North Carolina, 27612, United States

RECRUITING

Xencor Investigative Site

Beavercreek, Ohio, 45440, United States

RECRUITING

Xencor Investigative Site

Denton, Texas, 76201, United States

RECRUITING

Xencor Investigative Site

Georgetown, Texas, 78628, United States

RECRUITING

Xencor Investigative Site

Houston, Texas, 77024, United States

RECRUITING

Xencor Investigative Site

Houston, Texas, 77090, United States

RECRUITING

Xencor Investigative Site

Kingwood, Texas, 77339, United States

RECRUITING

Xencor Investigative Site

Lubbock, Texas, 79424, United States

RECRUITING

Xencor Investigative Site

San Antonio, Texas, 78229, United States

RECRUITING

Xencor Investigative Site

Tyler, Texas, 75701, United States

RECRUITING

Xencor Investigative Site

Wollongong, New South Wales, 2500, Australia

RECRUITING

Xencor Investigative Site

South Brisbane, Queensland, 4101, Australia

RECRUITING

Xencor Investigative Site

Southport, Queensland, 4215, Australia

RECRUITING

Xencor Investigative Site

Joondalup, Western Australia, 6027, Australia

COMPLETED

Xencor Investigative Site

Nedlands, Western Australia, 6009, Australia

COMPLETED

Xencor Investigative Site

Sofia, 1618, Bulgaria

RECRUITING

Xencor Investigative Site

Vancouver, British Columbia, V6Z 2K5, Canada

RECRUITING

Xencor Investigative Site

London, Ontario, N6K 1M5, Canada

RECRUITING

Xencor Investigative Site

Scarborough Village, Ontario, M1S4T7, Canada

RECRUITING

Xencor Investigative Site

Montreal, Quebec, H3H 1EB, Canada

RECRUITING

Xencor Investigative Site

Rijeka, 51000, Croatia

RECRUITING

Xencor Investigative Site

Zagreb, 10000, Croatia

RECRUITING

Xencor Investigative Site

Tbilisi, 0112, Georgia

RECRUITING

Xencor Investigative Site

Thessaloniki, 54642, Greece

RECRUITING

Xencor Investigative Site

Budapest, 1136, Hungary

RECRUITING

Xencor Investigative Site

Vác, 2600, Hungary

RECRUITING

Xencor Investigative Site

Chisinau, Moldova

RECRUITING

Xencor Investigative Site

Wroclaw, Lower Silesian Voivodeship, 53-611, Poland

RECRUITING

Xencor Investigative Site

Warsaw, Mazonian, 00-189, Poland

RECRUITING

Xencor Investigative Site

Sopot, Pomeranian Voivodeship, 81-756, Poland

RECRUITING

Xencor Investigative Site

Bydgoszcz, 85-079, Poland

RECRUITING

Xencor Investigative Site

Katowice, 40-748, Poland

RECRUITING

Xencor Investigative Site

Staszów, 28-200, Poland

RECRUITING

Xencor Investigative Site

Szczecin, 71-685, Poland

RECRUITING

Xencor Investigative Site

Warsaw, 004-501, Poland

RECRUITING

Xencor Investigative Site

Bucharest, District 1, 01-1658, Romania

RECRUITING

Xencor Investigative Site

Cluj-Napoca, 400006, Romania

RECRUITING

Xencor Investigative Site

Lutsk, Volyn Oblast, 43005, Ukraine

RECRUITING

Xencor Investigative Site

Ivano-Frankivsk, 76008, Ukraine

RECRUITING

Xencor Investigative Site

Kyiv, 01135, Ukraine

RECRUITING

Xencor Investigative Site

Kyiv, 02091, Ukraine

RECRUITING

Xencor Investigative Site

Lviv, 79000, Ukraine

RECRUITING

Xencor Investigative Site

Lviv, 79010, Ukraine

RECRUITING

Xencor Investigative Site

Lviv, 79059, Ukraine

RECRUITING

Xencor Investigative Site

Uzhhorod, 88000, Ukraine

RECRUITING

Xencor Investigative Site

Vinnytsia, 21009, Ukraine

RECRUITING

Xencor Investigative Site

Vinnytsia, 21028, Ukraine

RECRUITING

Xencor Investigative Site

Zhytomyr, 10001, Ukraine

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Mark Osterman, MD, MSCE

  Xencor, Inc.

  STUDY DIRECTOR

Central Study Contacts

Sudeepta Aggarwal

CONTACT

Xenith-UCinfo@xencor.com

Mark Osterman, MD, MSCE

CONTACT

Xenith-UCinfo@xencor.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 1, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); UA (11); US (19); CA (4); BU (1); AU (5); PL (8); MO (1); GR (1); CR (2); RO (2); HU (2)