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Monoclonal Antibodies

Long-Term Ustekinumab for Pediatric Crohn's Disease (UNITED Trial)

Phase 3

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration

Must have completed the dosing planned in the primary pediatric ustekinumab study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years and 4 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will help researchers understand the long-term effects of ustekinumab, a medication used to treat autoimmune diseases.

Who is the study for?

This trial is for pediatric patients who have completed a primary ustekinumab study for Crohn's Disease, Psoriatic Arthritis, or Ulcerative Colitis. They must show benefits from previous treatment and agree to lifestyle restrictions. Girls must not be pregnant and all participants should not plan on becoming parents soon.

What is being tested?

The trial is testing the long-term safety of ustekinumab, an injectable medication given under the skin (subcutaneous), in children who have shown improvement with this drug during a prior study.

What are the potential side effects?

While specific side effects are not listed here, long-term safety data collection suggests monitoring for any adverse reactions due to prolonged use of ustekinumab in young patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am capable of becoming pregnant and have a negative pregnancy test.

Select...

I have finished all my ustekinumab treatments as planned in a previous study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years and 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years and 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With AEs of Worsening of the Disease

Number of Participants With Adverse Events (AEs)

Number of Participants With Concomitant Therapy due to Loss of Response

+5 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Rash/Rash Acneiform/Maculo-Papular

Toothache

Hypertension

Pain/Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: UstekinumabExperimental Treatment1 Intervention

Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2015

Completed Phase 4

~4080

0 / 2Eligibility criteria met