A Study to Evaluate the Effectiveness, Safety and Movement of Ustekinumab in Pediatric Patients with Ulcerative Colitis

Overview

About this study

The global primary objectives of this study are, in pediatric participants with moderately to severely active ulcerative colitis (UC):

  • To evaluate the efficacy of ustekinumab dosing in inducing clinical remission;
  • To evaluate the safety profile of ustekinumab;
  • To evaluate ustekinumab exposure (pharmacokinetics [PK]).

The United States (US)-specific primary objectives of this study are, in pediatric participants with moderately to severely active UC:

  • To evaluate the efficacy of ustekinumab dosing in maintaining clinical remission among participants who were in clinical response in induction;
  • To evaluate the safety profile of ustekinumab;
  • To evaluate ustekinumab exposure (pharmacokinetics [PK]).

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator

- Must have had UC diagnosed prior to screening

- Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy

- A participant who has had extensive colitis for >= 8 years, or disease limited to the left side of the colon for >= 10 years, must: a) have had a full colonoscopy to assess
for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the
baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant)
prior to the first administration of study intervention

- Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration

Exclusion Criteria:

- Have UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon

- Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture
with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy)

- Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to
screening

- Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of
possible lymphoproliferative disease, such as lymphadenopathy of unusual size orlocation (example, nodes in the posterior triangle of the neck, infraclavicular,
epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly

- Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Stephens, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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