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Could a common Anti-Inflammatory pill boost biologic therapy for ulcerative colitis?

NCT ID NCT05205603

Disease control Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 looked at whether adding mesalazine (a standard anti-inflammatory drug) to biologic treatments like infliximab or vedolizumab helps people with moderate to severe ulcerative colitis achieve endoscopic remission (healing of the gut lining). The trial enrolled 438 adults and followed them for 12 months. The goal is to see if the combination works better than biologics alone.

What this could mean

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

Active substance
Mesalazine combined with a biologic (infliximab or vedolizumab)
What this could lead to
If it works, this could show that adding mesalazine to standard biologic therapy helps more people achieve endoscopic remission, potentially improving long-term disease control.
What could go wrong
This is a Phase 4 study, so the drugs are already approved, but the benefit of adding mesalazine is unclear. The trial is completed but results are not yet reported, so we don't know if the combination is truly better.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

438 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 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: 1. Patients with moderate and severe ulcerative colitis; 2. Subjects were above 18 years old and below 80 years; 3. Indications of 5-ASA or biological treatment; 4. According to the clinical symptoms, ulcerative colitis was diagnosed by endoscopic changes, pathological manifestations. The disease activity of UC was assessed according to the modified Mayo scoring system (modified Mayo: 6\~12 for patients with moderate to severe ulcerative colitis); 5. If the subject is a woman, a pregnancy test at baseline is needed to exclude pregnancy. Female patients must follow the contraceptive recommendations of the project; 6. Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol. Exclusion Criteria: 1. No indications of 5-ASA or biological treatment; 2. ulcerative colitis patients who had previously undergone a partial colectomy; 3. Patients who are unable to use 5-ASA for a long time; 4. Patients with severe, progressive, or uncontrolled kidney, liver, blood, or endocrine diseases or symptoms; 5. Presence of infected persons, Patients with a contraindication to the use of biological agents such as C. difficile infection or other intestinal pathogens, active tuberculosis or intestinal tuberculosis infection, human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C (defined as: ① HBV: hepatitis B surface antigen (HBs Ag) positive (+), Or patients with positive for hepatitis B core antibody (HBcAb) and the qualitative test results of HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) meet the detection criteria; ② HCV: Any patient with an anti-HCV antibody (HCV Ab) -positive patient with a detectable HCV ribonucleic acid (RNA); 6. Patients with a history of gastrointestinal dysplasia, or dysplasia on any biopsy performed on endoscopy, excluding low-grade dysplasia lesions; known history of lymphoproliferative disease (including lymphoma), or signs and symptoms (e. g., lymphadenopathy and / or splenomegaly); patients with current or previous malignancy; 7. Has been involved in other clinical studies.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Biologics Efficacy, self Mesalazine Ulcerative colitis

Contacts and locations

Locations

  • First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, China

  • First People's Hospital of Foshan

    Guangzhou, Guangdong, China

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, China

  • Guangzhou Panyu Central Hospital

    Guangzhou, Guangdong, China

  • Nanhai Hospital, Southern Medical University

    Guangzhou, Guangdong, China

  • People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, China

  • Shengjing Hospital

    Shenyang, Liaoning, China

  • Shunde Hospital of Southern Medical University

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, China

  • Zhejiang University

    Hanzhou, Zhejiang, China

  • the Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 501655, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.