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Two biologics go head to head in ulcerative colitis

NCT ID NCT06786507

Disease control Sponsor: Helwan 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers compare two biologic drugs, ustekinumab and infliximab, in adults with moderate to severe ulcerative colitis who have not previously tried biologic therapy. The trial measures how well each drug reduces inflammation, controls symptoms, and improves quality of life, while tracking side effects. About 100 participants will be assigned to one of the two treatments.

What this could mean

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

Active substance
ustekinumab and infliximab, two biologic drugs that calm inflammation in ulcerative colitis
What this could lead to
If one drug clearly outperforms the other, doctors could have better guidance on which biologic to try first for moderate to severe ulcerative colitis.
What could go wrong
This is a relatively small, single-center comparison. Results may not apply to all patients, and both drugs carry risks of infection and infusion reactions.

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.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Who is studied

moderate to severe ulcerative colitis bio naïve patients

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: * Subjects who are voluntarily able to give informed consent * Subjects who can participate in all aspects of this clinical study * Males and females aged from ≥ 18 to ≤ 80 years, at screening visit * Diagnosis of moderate to severe UC established by clinical and endoscopic evidence. * Biological therapy naïve patients. Exclusion Criteria: * \- Previous exposure to IFX or UST or any other in IFX or UST-containing product * Has a history of hypersensitivity or allergies to the ingredients of IFX or UST formulations * Unstable angina * Moderate or severe heart failure (defined as New York Heart Association Class III or IV) * Chronic respiratory failure * History of any major neurological disorders including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease * Chronic hepatitis B or C infection. Patients with positive viral serology at screening for infection with hepatitis B (HBV) or hepatitis C virus (HCV) may be eligible if the polymerase chain reaction test is negative, and the patients receive standard of-care antiviral prophylaxis (if applicable) * Known severe chronic kidney failure * Known severe chronic liver failure * Known active or latent tuberculosis * Ongoing HIV infection

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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.

Ulcerative colitis (UC)

Contacts and locations

Locations

  • El-Demerdash hospital

    Cairo, Egypt

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