Authorised Therapeutic exploratory (Phase II) Ulcerative Colitis is a type of inflammatory bowel disease, a chronic relapsing and remitting gastrointestinal disorder causing inflammation of the colonic and rectal mucosa.

A Multi-Stage Study to Test a New Drug in Healthy Adult Volunteers, Then in Adults with Ulcerative Colitis

EU CTIS ID: 2025-522702-21-00

What this study is testing

To evaluate the efficacy of XmAb942 on inducing clinical remission in participants with moderately to severely active UC

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1) Age 18-75
  • 2) Must be in good health with no significant medical history.
  • 3) Diagnosis of UC for ≥ 3 months prior to screening.
  • 4) Diagnosis 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.
  • 5) Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy.
  • 6) Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies for UC.

You likely can't join if

  • 1) Any physical or psychological condition that prohibits study participation.
  • 2) Diagnosis of Crohn's disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.
  • 3) Positive screen for Clostridium difficile (C. Difficile) toxins.
  • 4) HIV, hepatitis B and hepatitis C positive.
  • 5) Cardiac arrhythmia, or clinically significant abnormal ECG.
  • 6) Pregnant or breastfeeding.
See the full eligibility criteria
Who can join
  • 1) Age 18-75
  • 2) Must be in good health with no significant medical history.
  • 3) Diagnosis of UC for ≥ 3 months prior to screening.
  • 4) Diagnosis 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.
  • 5) Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy.
  • 6) Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies for UC.
  • 7) Able and willing to provide written informed consent.
What rules you out
  • 1) Any physical or psychological condition that prohibits study participation.
  • 2) Diagnosis of Crohn's disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.
  • 3) Positive screen for Clostridium difficile (C. Difficile) toxins.
  • 4) HIV, hepatitis B and hepatitis C positive.
  • 5) Cardiac arrhythmia, or clinically significant abnormal ECG.
  • 6) Pregnant or breastfeeding.

The study team makes the final eligibility decision.

Where it's taking place

  • Brazil
  • South Africa
  • Georgia
  • Serbia
  • Turkey
  • Jordan
  • Lebanon
  • Chile
  • Canada
  • Colombia
  • United States
  • Argentina
  • Australia
  • Moldova, Republic of
  • Ukraine

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brazil; South Africa; Georgia; Serbia; Turkey; Jordan and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.