A study testing XmAb942 compared to placebo in adults with moderate-to-severe active ulcerative colitis

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What is this study about?

This study involves Ulcerative Colitis, which is a long-lasting condition affecting the bowel where the lining of the large intestine and rectum becomes inflamed. The inflammation can cause symptoms that come and go over time. The treatment being tested is called XmAb942, which is an experimental medication given through infusion. Some participants will receive XmAb942 while others will receive placebo.

The purpose of this study is to evaluate how well XmAb942 works in helping people with moderately to severely active Ulcerative Colitis achieve clinical remission, which means bringing the disease under control so that symptoms improve significantly. The study is divided into two parts. The first part tests the medication in healthy volunteers to check its safety. The second part involves people who have moderate to severe Ulcerative Colitis and have not responded well to previous treatments, lost response to them, or could not tolerate them. Participants in the second part must have had Ulcerative Colitis for at least three months and show active disease with inflammation visible during examination of the bowel.

During the study, participants will be randomly assigned to receive either XmAb942 or placebo. The treatment period lasts up to 48 weeks, with an important assessment at week 12 to see if the medication is working. Doctors will measure improvement by looking at various signs of the disease, including bleeding, bowel movement frequency, and inflammation seen during bowel examination. The study will also monitor any side effects or unwanted reactions that occur during treatment to ensure the safety of participants.

1 Initial assessment and baseline measurements

At the start of the study, your condition will be assessed to establish baseline measurements.

Your ulcerative colitis activity will be evaluated using a modified Mayo score, which is a system that measures the severity of your disease based on stool frequency, rectal bleeding, findings from a colonoscopy, and a physician’s assessment.

A colonoscopy will be performed to examine the inside of your colon and rectum. This procedure will confirm that inflammation extends at least 15 centimeters from the anal opening.

The colonoscopy will also provide an endoscopic subscore, which rates the appearance of inflammation in your intestinal lining.

Your rectal bleeding and stool frequency will be recorded as part of the baseline assessment.

2 Random assignment to treatment group

You will be randomly assigned to receive either XmAb942 or placebo.

The placebo is a solution that looks identical to the active drug but contains no active ingredient. It consists of a buffer solution with sucrose and polysorbate.

Neither you nor the study staff will know which treatment you are receiving. This is called a double-blind design and helps ensure accurate results.

3 Treatment administration

You will receive your assigned treatment through intravenous infusion, which means the medication will be delivered directly into a vein through a needle.

Alternative routes of administration may include subcutaneous injection under the skin or intramuscular injection into a muscle, depending on the study protocol.

The specific dosage, frequency, and duration of treatment administration are determined by the study protocol but are not specified in the available information.

4 Treatment period up to week 12

You will continue receiving the assigned treatment according to the schedule determined by the study protocol.

Throughout this period, your symptoms and any side effects will be monitored.

Any adverse events, which are unwanted or harmful reactions that occur during treatment, will be recorded.

Your rectal bleeding and stool frequency will be tracked regularly to assess how your condition responds to treatment.

5 Week 12 assessment

At week 12, a comprehensive evaluation of your condition will be performed.

Another colonoscopy will be conducted to assess the current state of inflammation in your colon and rectum.

Your modified Mayo score will be calculated again to determine if your disease activity has improved.

The study will evaluate whether you have achieved clinical remission, which is defined as having minimal disease activity with a modified Mayo score of 2 or less, minimal or no inflammation seen on colonoscopy, no rectal bleeding, and stool frequency that is normal or nearly normal.

Endoscopic remission will be assessed, which means the inflammation seen during colonoscopy has resolved or is minimal.

Your response to treatment will be determined by comparing your week 12 scores to your baseline measurements.

Tissue samples taken during the colonoscopy will be examined under a microscope to evaluate histologic improvement, which means improvement in the cellular structure of your intestinal lining.

6 Safety monitoring throughout the study

Throughout the entire study period, any treatment-emergent adverse events will be recorded. These are any medical problems that occur after you start receiving treatment.

Serious adverse events, which are severe medical problems that may require hospitalization or are life-threatening, will be closely monitored.

If you experience significant treatment-related side effects, discontinuation of the study treatment may be necessary.

Who Can Join the Study?

  • You must be between 18 and 75 years old
  • You must be in good health with no major medical problems in your history
  • You must have been diagnosed with ulcerative colitis, which is a long-term condition causing inflammation and sores in the lining of the large intestine and rectum, for at least 3 months before joining the study
  • Your ulcerative colitis must be moderately to severely active, which means your symptoms are significant and affecting your daily life, as measured by a specific scoring system that looks at your stool frequency, rectal bleeding, doctor’s assessment, and findings during examination of your intestine
  • Your disease must affect at least 15 centimeters of your intestine measured from the opening of your rectum, which will be confirmed by a procedure called a colonoscopy where a doctor uses a thin tube with a camera to look inside your colon
  • You must have previously tried at least one standard or advanced treatment for ulcerative colitis and either it did not work well enough, it stopped working over time, or you could not tolerate it due to side effects
  • You must be able and willing to sign a consent form after understanding the study details

Who Cannot Join the Study?

  • The specific exclusion criteria (reasons why you cannot participate) have not been provided in the available study information
  • Generally, clinical trials have rules about who cannot join to ensure the safety of participants and the accuracy of the study results
  • Common reasons people may not be able to participate in studies like this one might include having other serious health conditions, taking certain medications, being pregnant or breastfeeding, or having had recent surgeries
  • You will need to discuss directly with the study team to learn the complete list of reasons that would prevent participation in this specific trial

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Medical Concierge Centrum Medyczne Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
Azienda Sanitaria Locale Roma 2 Rome Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Hospital Beatriz Angelo Loures Portugal
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
University General Hospital Of Heraklion Heraklion Greece
Sonomed Sp. z o.o. Szczecin Poland
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Eb Group Sp. z o.o. Warsaw Poland
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j. Staszow Poland
Centrum Medyczne Oporow Wroclaw Poland
Vita Longa Sp. z o.o. Katowice Poland
Endoskopia Sp. z o.o. Sopot Poland
Poliklinika Borzan d.o.o. Osijek Croatia
Prestige Magankorhaz Kft. Nyiregyhaza Hungary
Centrul Medical Unirea S.R.L. Brasov Romania
Azienda Ospedaliera di Padova Padua Italy
Evangelismos S.A. Athens Greece
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Melita Medical sp. z o.o. Wroclaw Poland
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Universitaire De Nice Nice France
Specijalna Bolnica Medico Rijeka Croatia
Javorszky Odon Korhaz Vac Hungary
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Poliklinika Solmed d.o.o. Zagreb Croatia
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Ames Research Center S.R.L. Bragadiru Romania
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Endomedix Kft. Budapest Hungary
Pannonia Maganorvosi Centrum Kft. Budapest Hungary
Aaihqkw Cokseat Smdkql Bucharest Romania
Vllbuuu Memkapm Seephs Ploiesti Romania
Mlemuukrtg Slqceb Bucharest Romania
Ljwpd Ghilhyf Hqkhyffx Oa Awbwsi Athens Greece
Ighikqyl dl Cdnnksfvmpsc Huttebcqxbv Uqquwakuzzicf dv Sybct Edvdjow (griagfm Saint Priest En Jarez France
Wew Wntioh Iuc Pfdzf Prexmomm Kvcuhyr Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
02.12.2025
Croatia Croatia
Recruiting
02.12.2025
France France
Not yet recruiting
02.12.2025
Germany Germany
Not yet recruiting
02.12.2025
Greece Greece
Recruiting
02.12.2025
Hungary Hungary
Recruiting
02.12.2025
Italy Italy
Not yet recruiting
02.12.2025
Poland Poland
Recruiting
02.12.2025
Portugal Portugal
Not yet recruiting
02.12.2025
Romania Romania
Recruiting
02.12.2025
Spain Spain
Not yet recruiting
02.12.2025

Trial locations

Investigated drugs:

XmAb942 is an investigational medication being studied for the treatment of ulcerative colitis. This medicine is being tested to see if it can help reduce the symptoms and inflammation in people who have moderate to severe active ulcerative colitis. The goal is to find out if this medication can help patients achieve clinical remission, which means bringing the disease under control so that symptoms improve or go away.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against the investigational medication to help determine if the actual medication is effective.

Ulcerative Colitis – Ulcerative Colitis is a type of inflammatory bowel disease that affects the digestive system. It is a chronic condition that follows a pattern of flare-ups and periods of remission throughout its course. The disease causes inflammation and ulcers in the innermost lining of the colon and rectum. During active periods, patients experience symptoms related to the inflamed intestinal tissue. The inflammation typically begins in the rectum and can spread continuously through the colon. This condition requires ongoing management as it persists over time with alternating periods of active disease and symptom-free intervals.

Trial ID:
2025-522702-21-00
Protocol code:
XmAb942-01 G942-101
NCT ID:
NCT06619990
Trial Phase:
Therapeutic exploratory (Phase II)

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