Clinical trial • Phase I/II • Immunology|Gastroenterology

XMAB942 for Ulcerative colitis

Phase I/II trial of XMAB942 for Ulcerative colitis.

Overview

Trial Therapeutic Area
Immunology|Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Phase I/II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
04-09-2025
First CTIS Authorization Date
12-01-2026

Trial design

Randomised, placebo (matching formulation excipients at same concentration and ph as xmab942; contains no active ingredient; consists of 20 mm histidine buffer, 7% (w/v) sucrose, and 0.04% polysorbate 80 at ph 6.0).-controlled Phase I/II trial across 50 sites in France, Germany, Portugal and others.

Randomised
Yes
Comparator
Placebo (matching formulation excipients at same concentration and pH as XmAb942; contains no active ingredient; consists of 20 mm histidine buffer, 7% (w/v) sucrose, and 0.04% polysorbate 80 at pH 6.0).
Target Sample Size
166
Trial Duration For Participant
84

Eligibility

Recruits 166 No vulnerable populations selected; participants must be able and willing to provide written informed consent..

Pregnancy Exclusion
6) Pregnant or breastfeeding.
Vulnerable Population
No vulnerable populations selected; participants must be able and willing to provide written informed consent.

Inclusion criteria

  • {"criterion_text":"- 1) Age 18-75"}
  • {"criterion_text":"- 2) Must be in good health with no significant medical history."}
  • {"criterion_text":"- 3)\tDiagnosis of UC for ≥ 3 months prior to screening."}
  • {"criterion_text":"- 4)\tDiagnosis of moderately to severely active UC as defined by a modified Mayo score (MMS) of ≥ 5, with a Mayo endoscopic subscore (ES) of ≥ 2 and rectal bleeding subscore ≥ 1."}
  • {"criterion_text":"- 5)\tEvidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy."}
  • {"criterion_text":"- 6) Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies for UC."}
  • {"criterion_text":"- 7) Able and willing to provide written informed consent."}

Exclusion criteria

  • {"criterion_text":"- 1) Any physical or psychological condition that prohibits study participation."}
  • {"criterion_text":"- 2) Diagnosis of Crohn's disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis."}
  • {"criterion_text":"- 3) Positive screen for Clostridium difficile (C. Difficile) toxins."}
  • {"criterion_text":"- 4) HIV, hepatitis B and hepatitis C positive."}
  • {"criterion_text":"- 5) Cardiac arrhythmia, or clinically significant abnormal ECG."}
  • {"criterion_text":"- 6) Pregnant or breastfeeding."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical remission at Week 12, defined as an MMS ≤ 2, with ES of ≤ 1 (excluding friability), a rectal bleeding (RB) subscore of 0, stool frequency (SF) subscore of ≤ 1 (with a ≥ 1 point decrease from baseline).","definition_or_measurement_approach":"Clinical remission at Week 12 defined by modified Mayo score (MMS) ≤ 2, Mayo endoscopic subscore (ES) ≤ 1 (excluding friability), RB subscore = 0, SF subscore ≤ 1 with ≥1 point decrease from baseline."}

Secondary endpoints

  • {"endpoint_text":"- TEAEs, treatment-related TEAEs, SAEs, discontinuations due to treatment related TEAEs.","definition_or_measurement_approach":"Safety endpoints: treatment-emergent adverse events, treatment-related TEAEs, serious adverse events and discontinuations due to treatment-related TEAEs as recorded during study."}
  • {"endpoint_text":"- Endoscopic remission defined as an ES ≤ 1 (excluding friability) at Week 12.","definition_or_measurement_approach":"Endoscopic remission measured by Mayo endoscopic subscore (ES) ≤ 1 (excluding friability) at Week 12."}
  • {"endpoint_text":"- MMS score at baseline and Week 12.","definition_or_measurement_approach":"Modified Mayo score (MMS) measured at baseline and at Week 12."}
  • {"endpoint_text":"- Clinical response at Week 12 defined as: o\tdecrease from baseline in the MMS of ≥ 2 points and at least a 30% reduction from baseline, and o \tdecrease ≥ 1 point in RB from baseline or RB of ≤ 1","definition_or_measurement_approach":"Clinical response at Week 12 defined as ≥2 point decrease in MMS and ≥30% reduction from baseline, and either ≥1 point decrease in RB from baseline or RB ≤ 1."}
  • {"endpoint_text":"- Histologic improvement (as defined in the Statistical Analysis Plan [SAP]) at Week 12.","definition_or_measurement_approach":"Histologic improvement assessed per definition specified in the study Statistical Analysis Plan (SAP) at Week 12."}

Recruitment

Planned Sample Size
166
Recruitment Window Months
28
Consent Approach
Participants must be able and willing to provide written informed consent. Study information and informed consent forms available in multiple languages (English and country-specific ICFs present: FR, DE, PT, ES, HR, BG, HU, IT, PL, RO, GR as per submitted documents). No assent process described (adult participants 18-75).

Geography

Total Number Of Sites
50
Total Number Of Participants
148

France

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
28
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Gastroenterology
Contact Person Name
Xavier Roblin
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastrooenterology
Contact Person Name
Mathieu Uzzan
Contact Person Email
mathieu.uzzan@aphp.fr
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
Gastroenterology
Contact Person Name
Carmen Stefanescu
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Gastroenterology
Contact Person Name
Maria Nachury
Contact Person Email
maria.nachury@chu-lille.fr
Site Name
Hospices Civils De Lyon
Department Name
Hepato-Gastroenterology
Contact Person Name
Gilles Boschetti
Contact Person Email
Gilles.boschetti@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Gastroenterology
Contact Person Name
Adrien Nicolau
Contact Person Email
nicolau.a@chu-nice.fr

Germany

Earliest CTIS Part Ii Submission Date
21-04-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
8
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Gastroenterology, Infectious Diseases and Rheumatology
Contact Person Name
Britta Siegmund
Contact Person Email
britta.siegmund@charite.de
Site Name
Dr. med. Thomas Brunk Gastroenterologie Berlin
Contact Person Name
Thomas Brunk
Contact Person Email
ced@gastroenterologie-brunk.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Gastroenterology, Hepatology and Infectiology
Contact Person Name
Andreas Stallmach
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Clinic for Internal Medicine
Contact Person Name
Stefan Schreiber
Contact Person Email
stefan.schreiber@uksh.de

Portugal

Earliest CTIS Part Ii Submission Date
12-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
15
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Hospital Beatriz Angelo
Department Name
Gastroenterology
Contact Person Name
Lidia Ramos
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Gastroenterology
Contact Person Name
Maria Fernandes Estevinho

Spain

Earliest CTIS Part Ii Submission Date
19-03-2026
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
27
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Centro Medico Teknon-Grupo Quironsalud
Department Name
Gastroenterology
Contact Person Name
Miquel Sans Cuffi
Contact Person Email
msans@digestek.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Gastroenterology
Contact Person Name
Mariam Aguas Peris
Contact Person Email
m.aguas.peris@gmail.com

Croatia

Earliest CTIS Part Ii Submission Date
18-12-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
137
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Poliklinika Borzan d.o.o.
Department Name
Gastroenterology
Contact Person Name
Vladimir Borzan
Contact Person Email
study@poliklinika-borzan.hr
Site Name
Specijalna Bolnica Medico
Department Name
Gastroenterology
Contact Person Name
Boris Brozovic
Contact Person Email
borisbrozovic@yahoo.com
Site Name
Poliklinika Solmed d.o.o.
Department Name
Clinical Research
Contact Person Name
Dominik Kralj

Greece

Earliest CTIS Part Ii Submission Date
21-11-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
109
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
2nd Propedeutic Department of Internal Medicine,Medical School,Aristotle university of Thessalonniki
Contact Person Name
Olga Giouleme
Contact Person Email
giouleme@auth.gr
Site Name
Evangelismos S.A.
Department Name
Gastroenterology Department
Contact Person Name
Nikos Viazis
Contact Person Email
Nikos.Viazis@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Gastroenterology Department
Contact Person Name
Ioannis Koutroubakis
Contact Person Email
ikoutroub2@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Gastroenterology, 3rd Internal Medicine Academic Department
Contact Person Name
Giorgos Bamias
Contact Person Email
gbamias@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
142
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliera di Padova
Department Name
Gastroenterology
Contact Person Name
Edoardo Savarino
Contact Person Email
edoardo.savarino@unipd.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Chronic Inflammatory Bowel Disease Unit
Contact Person Name
Alessandro Armuzzi
Contact Person Email
alessandro.armuzzi@hunimed.eu
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroenterology and Gastrointestinal Endoscopic Unit
Contact Person Name
Silvio Danese
Contact Person Email
danese.silvio@hsr.it
Site Name
Azienda Sanitaria Locale Roma 2
Department Name
Gastroenterology
Contact Person Name
Roberta Pica
Contact Person Email
Roberta.pica@aslroma2.it

Romania

Earliest CTIS Part Ii Submission Date
10-12-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
135
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Gastroenterology
Contact Person Name
Vlad-Andrei Ichim
Contact Person Email
vlad.ichim.ext@arensia-em.com
Site Name
Arensia Clinics S.R.L.
Department Name
Gastroenterology and Hepatology
Contact Person Name
Iulia Simionov
Site Name
Centrul De Gastroenterologie Dr. Goldis S.R.L.
Department Name
Gastroenterology
Contact Person Name
Adrian Goldis
Contact Person Email
goldisadi@yahoo.com
Site Name
Centrul Medical Unirea S.R.L.
Department Name
Gastroenterology
Contact Person Name
Diana Candescu
Contact Person Email
candescu.diana@yahoo.com
Site Name
Valahia Medical S.R.L.
Department Name
Gastrooenterology
Contact Person Name
George Stancu
Site Name
Monza-Ares S.R.L.
Department Name
Gastroenterology
Contact Person Name
Theodor Voiosu
Contact Person Email
theodor.voiosu@yahoo.com
Site Name
Ames Research Center S.R.L.
Department Name
Gastrooenterology
Contact Person Name
Adriana Deacu
Contact Person Email
adriana.deacu@ames-research.ro
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Gastroenterology
Contact Person Name
Bogdan Mateescu
Contact Person Email
bogmateescu@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
112
Number Of Sites
11
Number Of Participants
40

Sites

Site Name
Vivamed Sp. z o.o.
Department Name
Gastrooenterology
Contact Person Name
Robert Petryka
Contact Person Email
robert@petrykamed.com
Site Name
Melita Medical Sp. z o.o.
Department Name
Gastroenterology
Contact Person Name
Jaroslaw Leszczyszyn
Contact Person Email
j.leszczyszyn@melitamedical.pl
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kiekrus@med-net.pl
Site Name
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
Department Name
Gastroenterology
Contact Person Name
Jacek Kieltucki
Site Name
Vitamed Galaj I Cichomski Sp. j.
Department Name
Gastroenterology
Contact Person Name
Michal Walczak
Contact Person Email
mi.walczak@wp.pl
Site Name
Eb Group Sp. z o.o.
Department Name
Gastroenterology
Contact Person Name
Miłosz Jastrzębski
Contact Person Email
milosz.jastrzebski@czmdm.pl
Site Name
Endoskopia Sp. z o.o.
Department Name
Gastroenterology
Contact Person Name
Marek Horynski
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Vita Longa Sp. z o.o.
Department Name
Gastroenterology
Contact Person Name
Przemyslaw Ramos
Site Name
Sonomed Sp. z o.o.
Department Name
Gastroenterology
Contact Person Name
Anna Wiechowska-Kozlowska
Site Name
Centrum Medyczne Oporow
Department Name
Gastroenterology
Contact Person Name
Radosław Kempiński
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Department Name
Gastroenterology
Contact Person Name
Monika Augustyn
Contact Person Email
amonika@interia.pl

Hungary

Earliest CTIS Part Ii Submission Date
29-10-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
141
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Geomedical Kft.
Department Name
Gastrooenterology
Contact Person Name
Gabor Hegede
Contact Person Email
gab.heg@freemail.hu
Site Name
Pannonia Maganorvosi Centrum Kft.
Department Name
Gastroenterology
Contact Person Name
Robert Schnabel
Contact Person Email
schnabelrobert@hotmail.com
Site Name
Endomedix Kft.
Department Name
Gastroenterology
Contact Person Name
Alajos Takats
Site Name
Prestige Magankorhaz Kft.
Department Name
Gastroenterology
Contact Person Name
Lorant Agoston
Contact Person Email
agostonlorant@hotmail.com
Site Name
Javorszky Oedoen Korhaz
Department Name
Gastroenterology
Contact Person Name
Tibor Szaloki
Contact Person Email
szalokitdr@javorszky.hu

Bulgaria

Earliest CTIS Part Ii Submission Date
24-11-2025
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
163
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department Name
Gastroenterology
Contact Person Name
Dimitar Dimitrov

Sponsor

Primary sponsor

Full Name
Xencor Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"codes: 1,11,12,13,2,3,5,6,9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Acelabio (US) Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Biologics Development Services LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Millmount Healthcare Limited","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Australia","full_name":"Agilex Biolabs Pty Limited","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"codes: 15 (Site Payments)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"codes: 15 (Equipment and materials supply)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
XmAb942
Active Substance
XMAB942
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
Route
INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
Maximum Dose
960 mg
Investigational Product Name
Placebo (matching formulation excipients)
Modality
Other

Related trials

Other published trials that may interest you.