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New hope for kids with severe colitis: drug trial shows promise

NCT ID NCT03596645

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tests a drug called golimumab in children aged 2-17 with moderate-to-severe ulcerative colitis, a chronic bowel disease causing inflammation and symptoms like diarrhea and bleeding. The goal is to see if the drug can bring about remission (symptom relief) within 6 weeks and monitor safety over a year. About 84 children will receive injections, and the study is already completed but not recruiting new participants.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

84 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Feb 2027

An estimate. End dates often move.

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

2 to 17 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: * Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis \[UC\]) OR required more than 3 courses of corticosteroids in the past year * Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 \[endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist\], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (\>=2) * If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Participants who receive parenteral nutrition are not permitted to enroll in the trial * No history of latent or active tuberculosis prior to screening * Must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before Week 0 Exclusion Criteria: * History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances * History of malignancy or macrophage activation syndrome or hemophagocytic lymphohistiocytosis * Have UC limited to the rectum only or to \<20 percent (%) of the colon * Presence of a stoma * Presence or history of a fistula * Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information

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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.

Colitis ulcerative

Contacts and locations

Locations

  • AOU Meyer

    Florence, 50139, Italy

  • AOU Policlinico G.Martino

    Messina, 98124, Italy

  • AOU Policlinico Umberto I

    Roma, 00161, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Assaf Harofeh Medical Center

    Rishon LeZiyyon, 70300, Israel

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna, 40133, Italy

  • BR Trials

    São Paulo, 01236030, Brazil

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013, Italy

  • Centrum Zdrowia Matki Dziecka i Mlodziezy

    Warsaw, 00 635, Poland

  • Chang Gung Memorial Hospital- Linkou

    Taoyuan City, 33305, Taiwan

  • Children's Center for Digestive Health Care

    Atlanta, Georgia, 30342, United States

  • Children's Hospital Colorado and University of Colorado

    Aurora, Colorado, 80045, United States

  • Children's Medical Center of Dallas

    Dallas, Texas, 75207, United States

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106, United States

  • Cook Childrens Medical Center

    Fort Worth, Texas, 76104, United States

  • DHAT Research Institute

    Garland, Texas, 75044, United States

  • Emma Children's Hospital Academic Medical Center

    Amsterdam, 1105 AZ, Netherlands

  • GI For Kids

    Knoxville, Tennessee, 37922, United States

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux, 33000, France

  • Hosp Regional Univ de Malaga

    Málaga, 29011, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28036, Spain

  • Hosp. Infantil Univ. Nino Jesus

    Madrid, 28009, Spain

  • Hosp. Sant Joan de Deu

    Barcelona, 08950, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. de Cruces

    Barakaldo, 48902, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Pequeno Principe

    Curitiba, 80250-060, Brazil

  • Hôpital Necker

    Paris, 75015, France

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste, 34137, Italy

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165, Italy

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035-074, Brazil

  • Isala Kliniek

    Zwolle, 8000 GK, Netherlands

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302, Poland

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • MK Blumenau Pesquisa Clínica

    Blumenau, 89010-506, Brazil

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Nemours DuPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Rocky Mountain Pediatric Gastroenterology

    Lone Tree, Colorado, 80124, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 91031, Israel

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Sourasky Medical Center

    Tel Aviv, 6997801, Israel

  • Szpital Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730, Poland

  • Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza

    Bydgoszcz, 85 094, Poland

  • Szpital im. M. Kopernika

    Gdansk, 80 803, Poland

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • UZ Brussel

    Jette, 1090, Belgium

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussels, 1020, Belgium

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30 663, Poland

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im Prof Stanislawa Popowskiego

    Olsztyn, 10 561, Poland

More trials for these conditions

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