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New pill for ulcerative colitis shows promise, but trial halted early

NCT ID NCT05785715

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral medication, NX-13, in 81 adults with moderate to severe ulcerative colitis. Participants received either NX-13 or a placebo for 12 weeks, with a long-term follow-up option. The trial was terminated early, so the full results are not available, but the data may still help researchers understand if NX-13 can safely control disease activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NX-13 (oral tablet)
What this could lead to
If successful, NX-13 could offer a new oral treatment option to help control moderate to severe ulcerative colitis.
What could go wrong
This early-phase trial was terminated, so results are limited. It is unclear if NX-13 is effective or safe; more research is needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

81 people

The number who actually took part.

Started

Apr 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult subjects aged 18 to 75 years (inclusive) * Diagnosis of UC ≥ 90 days before screening confirmed by histologic evidence * Active UC defined as a total Mayo Score (MMS) of ≥ 5 (inclusive) at baseline * ES ≥ 2 within 14 days prior to randomization * RBS ≥ 1. Exclusion Criteria: * Severe extensive colitis as evidenced by physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization; * Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation * Diagnosis of Crohn's disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD * Diagnosis of microscopic colitis, ischemic colitis, or radiation colitis * Bacterial or parasitic pathogenic enteric infection;

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Conditions

The condition(s) this trial relates to.

follicular lymphoma ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • AmiCare Centrum Medyczne

    Jelenia Góra, Poland

  • AmiCare Sp. z o.o. Sp.k.

    Lodz, Poland

  • Amicare Sp z o.o. S.K

    Opoczno, Poland

  • Azienda Ospedaliera - Universitaria Sant' Andrea

    Roma, Italy

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, Italy

  • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.

    Wroclaw, Poland

  • Centrum Diagnostyczno - Lecznicze Barska

    Włocławek, Poland

  • ClinSante - Ośrodek Badań Klinicznych w Bydgoszczy

    Bydgoszcz, Poland

  • Clinical Research Institute of Michigan

    Troy, Michigan, 48098, United States

  • Digestive Disease Specialist, Inc-INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma, 73112, United States

  • Digestive Health Associates of Texas-GI Alliance

    Mansfield, Texas, 76003, United States

  • Digestive Health Associates of Texas-GI Alliance Research-Garland

    Garland, Texas, 75044, United States

  • Digestive Health Center of Michigan

    Chesterfield, Michigan, 48047, United States

  • Endoskopia Sp. z o.o.

    Sopot, Poland

  • GCP Clinical Research

    Tampa, Florida, 33609, United States

  • H-T Centrum Medyczne

    Tychy, Poland

  • IRCCS Fondazione Casa Sollievo della Sofferenza SG Rotondo

    San Giovanni Rotondo, Italy

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

    Rozzano, Italy

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

    Milan, Italy

  • Krakowska Przychodnia FutureMeds

    Krakow, Poland

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • Office of Jaroslaw Kierkus, Dr N Med

    Warsaw, Poland

  • Orlando Health, Inc.

    Orlando, Florida, 32806, United States

  • Przychodnia Vitamed NFZ

    Bydgoszcz, Poland

  • RiverMED Poradnie Specjalistyczne Poznań

    Poznan, Poland

  • Sonomed Sp. z o.o. Centrum Medyczne

    Szczecin, Poland

  • Texas Digestive Disease Consultants-GI Alliance Research

    Southlake, Texas, 76092, United States

  • Torunskiego Centrum Gastrologii I Endoskopii - Gastromed

    Torun, Poland

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, Poland

  • Twoja Przychodnia Szczecińskie Centrum Medyczne

    Szczecin, Poland

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Belgium

  • VITA LONGA Clinic - Katowice

    Katowice, Poland

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110, United States

  • Zabobrze Centrum Medyczne

    Wroclaw, Poland

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