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Crohn DiseasePhase 3UNITI JrNCT04673357

A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

A Phase 3 study testing Ustekinumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 53 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active Crohn's disease. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Crohn Disease
What is being tested?
Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
53 sitesin 9 countries
Study dates
6 Apr 2021to 3 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Have Crohn's disease or fistulizing Crohn's disease with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by endoscopy and histology
  • Must have moderately to severely active Crohn's disease (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than [>] 30); have ileocolonoscopy with evidence of active Crohn's disease defined as presence of ulceration (which is equal to Simple Endoscopic Score for Crohn's disease [SES-CD] score greater than or equals to [>=] 3) during screening into this study. The ileocolonoscopy procedure must occur within approximately 3 weeks prior to the administration of study intervention at Week 0 (Induction Period). A video ileocolonoscopy recorded within 3 months prior to the Week 0 (Induction Period) visit may be used in case of rescreening of a participant who had an ileocolonoscopy but failed the initial screening for another reason, on a case-by-case basis, after consultation with the sponsor. If unable to evaluate ulceration due to stricture or inadequate bowel preparation, at least one of the following criteria may instead be applied: an abnormal C-reactive protein (CRP) (> 0.3 milligram per deciliter [mg/dL] or 3.0 milligram per liter [mg/L] at screening) or; fecal calprotectin of >= 250 milligram per kilogram [mg/kg] or >= 250 microgram per gram [mcg/g] at screening
  • If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to induction week 0 (Week I-0)
  • 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

Who cannot join

  • Has complications of Crohn's disease such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, that could preclude the use of the PCDAI to assess response to therapy or would possibly confound the ability to assess the effect of treatment with ustekinumab
  • 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 or location (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
  • Have a history of moderate or severe progressive or uncontrolled liver or renal insufficiency; or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric (including suicidality), or metabolic disturbances
  • Received an investigational intervention including any investigational vaccines or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or is currently enrolled in an investigational study; receipt of an investigational vaccine for Coronavirus Disease 2019 (COVID-19) is not an automatic exclusion criterion

Trial locations and contacts

53 sites in 9 countries.

53 sites in 9 countries

United States9 sites

  • Children's Center for Digestive Health Care

    Atlanta, Georgia, 30342

  • Levine Childrens at Atrium Health

    Charlotte, North Carolina, 28207

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Pediatric Specialists Of Virginia

    Fairfax, Virginia, 22031

  • Cook Childrens Medical Center

    Fort Worth, Texas, 76104

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17033

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Nemours DuPont Hospital for Children

    Wilmington, Delaware, 19803

Other trials in United States

Japan9 sites

  • Juntendo University Hospital

    Bunkyō City, 113 8431

  • Gunma University Hospital

    Gunma, 371-0034

  • Kindai University Nara Hospital

    Ikoma, 630-0293

  • Kurume University Hospital

    Kurume, 830-0011

  • Saitama Childrens Medical Center

    Saitama Shi, 330-8777

  • Miyagi Children's Hospital

    Sendai, 989-3126

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498

  • Mie University Hospital

    Tsu, 514 8507

Other trials in Japan

Germany7 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

  • Charite-Universitätsmedizin Berlin - Berlin

    Berlin, 13353

  • Universitatsklinikum Essen

    Essen, 45147

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Dr. von Haunersches Kinderspital

    Munich, 80337

  • KUNO Klinik St. Hedwig

    Regensburg, 93049

  • Universitatsklinikum Ulm

    Ulm, 89075

Other trials in Germany

Belgium5 sites

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussels, 1020

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

  • UZ Brussel

    Jette, 1090

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Hungary5 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400

  • Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum

    Szeged, 6720

Other trials in Hungary

Poland5 sites

  • Szpital im. M. Kopernika

    Gdansk, 80 803

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30 663

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04 730

Other trials in Poland

United Kingdom5 sites

  • Birmingham Children's Hospital

    Birmingham, B4 6NH

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS2 8BJ

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Royal Hospital for Children and Young People

    Edinburgh, EH16 4TJ

  • Royal London Hospital

    London, E1 2AT

Other trials in United Kingdom

Israel4 sites

  • Yitzhak Shamir Medical Center

    Be’er Ya‘aqov, 70300

  • Carmel Medical Center

    Haifa, 34362

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Schneider Children's Medical Center

    Petah Tikva, 4920235

Other trials in Israel

Russia4 sites

  • Kazan State Medical University

    Kazan', 420138

  • Russian National Research Medical University named after N.I.Pirogov

    Moscow, 119571

  • Privolzhsky Research Medical University of Ministry of Health of Russian Federation

    Nizhny Novgorod, 603950

  • Yaroslavl Regional Children's Clinical Hospital

    Yaroslavl, 150032

Other trials in Russia

About this study

Official title: A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active Crohn's disease.

Conditions
Crohn Disease
Being tested
Ustekinumab, Placebo
Keywords
Pediatric
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

    Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

  • PlaceboDrug

    Matching placebo will be administered as SC injection.

Study groups in NCT04673357
Study groupRoleWhat they receive
Open- Label Ustekinumab Intravenous (IV): Induction PeriodExperimentalAll participants will receive a single IV administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square [mg/m^2]) or weight-tiered induction dose (milligram per kilogram [mg/kg]).
Receives: Drug: Ustekinumab
Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance PeriodExperimentalParticipants will receive SC administration of ustekinumab q8w based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at maintenance weeks (Weeks M)-0, M-8, M-16, M-24, M 32, and M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.
Receives: Drug: Ustekinumab; Drug: Placebo
Ustekinumab SC Every 12 Weeks (q12w): Maintenance PeriodExperimentalParticipants will receive SC administration of ustekinumab q12w based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.
Receives: Drug: Ustekinumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Outcome Measure: Percentage of Participants With Clinical Remission at Induction Week 8 (Week I-8)

    Clinical remission was defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score <=10. The 11-item PCDAI covered five general disease activity domains: symptom history scores (3 items: abdominal pain, stool frequency, and general well-being); laboratory scores (3 items: hematocrit [HCT], erythrocyte sedimentation rate [ESR], Albumin); growth scores (2 items: weight and height); physical examination scores (2 items: abdomen and perirectal disease); and extraintestinal manifestations. The category of severity for each index item is assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score =5. For albumin level, the maximum score = 10. All items were summed to derive the total score. The total PCDAI score ranged from 0 to 100, with higher scores indicating greater disease activity.

    Measured: Induction Week 8 (Week I-8)

  2. US-specific Outcome Measure: Percentage of Participants With Clinical Remission at Maintenance Week 44

    Clinical remission was defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score <=10. The 11-item PCDAI covered five general disease activity domains: symptom history scores (3 items: abdominal pain, stool frequency, and general well-being); laboratory scores (3 items: HCT, ESR, Albumin); growth scores (2 items: weight and height); physical examination scores (2 items: abdomen and perirectal disease); and extraintestinal manifestations. The category of severity for each index item was assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score= 5. For albumin level, the maximum score= 10. All items were summed to derive the total score. The total PCDAI score ranged from 0 to 100, with higher scores indicating greater disease activity.

    Measured: Maintenance Week 44 (Study Week 52)

  3. Global and US-specific Outcome Measures: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Number of participants with TEAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE did not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs occurring at or after the initial administration of the study intervention.

    Measured: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)

  4. Global and US-specific Outcome Measures: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

    Number of participants with TESAEs was reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE did not necessarily have a causal relationship with the intervention. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly. TESAEs were defined as any SAE occurring at or after the initial administration of the study intervention.

    Measured: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)

  5. Global and US-specific Outcome Measures: Number of Participants With AEs Leading to Discontinuation of Study Intervention

    Number of participants with AEs leading to discontinuation of study intervention were reported.

    Measured: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 40 (Study Week 48)

  6. Global and US-specific Outcome Measures: Number of Participants With AEs of Special Interest (AESI)

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE did not necessarily have a causal relationship with the intervention. AESI were defined as any newly identified malignancy, or case of active TB, or opportunistic infection occurring after the first administration of study intervention.

    Measured: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)

  7. Global and US-specific Outcome Measures: Number of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology

    Number of participants with abnormalities in clinical laboratory parameters (hematology) were reported. It included hemoglobin (Hb). Grades 0-4 were based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), where Grade 0 was normal, Grade 1 was mild, Grade 2 was moderate, Grade 3 was severe or medically significant but not immediately life-threatening, and Grade 4 was life-threatening consequences. Higher grades showed more severe abnormalities. Only abnormalities where atleast one participant had data are reported. Inc = increased, Dec= decreased.

    Measured: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)

  8. Global and US-specific Outcome Measures: Number of Participants With Abnormalities in Clinical Laboratory Parameters: Chemistry

    Number of participants with abnormalities in clinical laboratory parameters were reported. It included chemistry measures: alanine aminotransferase (ALT), aspartate aminotransferase (AST),blood bilirubin (BB). Grades 0-4 were based on NCI-CTCAE version 5.0, where Grade 0 was Normal, Grade 1 was mild, Grade 2 was moderate, Grade 3 was severe or medically significant but not immediately life-threatening, and Grade 4 was life-threatening consequences. Higher grades showed more severe abnormalities. Only abnormalities where at least one participant had data are reported. Inc = increased, Dec= decreased.

    Measured: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)

  9. Global and US-specific Outcome Measures: Number of Participants With Reactions Temporally Associated With Intravenous (IV) Infusion (Induction Period) and Subcutaneous (SC) Injection-Site Reactions (Maintenance Period)

    Number of participants with reactions temporally associated with intravenous (IV) infusion (Induction Period) and subcutaneous (SC) Injection-Site Reactions (Maintenance Period) were reported.

    Measured: Induction Period: From induction Week 0 up to induction Week 8; Maintenance Period: From Maintenance Week 0 (Study Week 8) up to Maintenance Week 44 (Study Week 52)

  10. Global and US-specific Outcome Measures: Serum Ustekinumab Concentrations

    Serum ustekinumab concentrations were reported.

    Measured: Induction Period: Week 0 (Pre-infusion), Week I-0 (1-hour post infusion), Week I-3, Week I-6, and Week I-8; Maintenance Period: Week M-4, Week M-8, Week M-12, Week M-16, Week M-24, Week M-32, Week M-36 and Week M-44

Secondary outcomes (9)

  1. Global Outcome Measure: Percentage of Participants With Clinical Remission at Induction Week 6 as Assessed by Short Pediatric Crohn's Disease Activity Index (sPCDAI)

    Clinical remission was defined as a short Pediatric Crohn's Disease Activity Index (sPCDAI) score <=10. The sPCDAI was composed of six components: abdominal pain, stool frequency, patient general well-being, body weight, abdominal examination (abdominal mass and tenderness), and extraintestinal manifestations. Each component was assigned a score of 0, 5, 10, or 20, depending on the severity of findings, with higher scores indicating greater disease activity, while lower scores (closer to 0) reflected clinical remission or minimal disease activity. Individual component scores were summed to derive the total sPCDAI score, which ranged from 0 to 90. Higher score indicate greater severity. The sPCDAI score was calculated only when >=3 of the 6 components were available.

    Measured: Induction Week 6 (Week I-6)

  2. Global Outcome Measure: Percentage of Participants With Clinical Response at Induction Week 8

    Assessment of response in children with Crohn's disease was evaluated using the PCDAI. Clinical response was defined as a reduction from baseline of >=12.5 points in the PCDAI score, calculated by summing weighted scores from 11 items across five domains: symptom history (abdominal pain, stool frequency, and general well-being); laboratory scores (hematocrit, erythrocyte sedimentation rate, and albumin); growth scores (weight and height); physical examination scores (abdominal and perirectal disease); and extraintestinal manifestations. Each index item was assigned a severity score of 0 (normal), 5 (mild abnormality), or 10 (severe abnormality). For HCT and ESR, maximum score was 5, and for albumin level, maximum score was 10. The total PCDAI score ranged from 0 to 100, with higher scores indicating greater disease activity. Lower PCDAI scores reflected lower disease activity, with a resulting score of <=30 on the 0-100 scale.

    Measured: Induction Week 8

  3. Global and US-specific Outcome Measures: Percentage of Participants With Clinical Response at Induction Week 6 as Assessed by sPCDAI

    sPCDAI clinical response was defined as reduction from baseline in the sPCDAI score of >=10. The 6-item sPCDAI score ranges from 0 (no disease activity) to 90 (severe disease activity),calculated by summing weighted scores for abdominal pain, stool frequency, general well-being, body weight, abdominal exam, and extraintestinal manifestations. Each component was assigned a score of 0, 5, 10, or 20, depending on the severity of findings, with higher scores indicating greater disease activity, while lower scores (closer to 0) reflected minimal disease activity. Individual component scores were summed to derive the total sPCDAI score, which ranged from 0 to 90. Higher score indicate greater severity. The sPCDAI score was only calculated when >=3 of the 6 components were available.

    Measured: Induction Week 6

  4. Global Outcome Measure: Percentage of Participants With Endoscopic Response at Maintenance Week 8 as Assessed by Simplified Endoscopic Score-Crohn's Disease (SES-CD)

    Endoscopic response was assessed using the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD), a validated endoscopic scoring system based on four components: size of ulcers, extent of ulcerated surface, extent of affected surface, and presence of narrowing. Each component was scored from 0 to 3 across five intestinal sections: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum. Component scores were summed across all sections to derive a total SES-CD score ranging from 0 to 56, with higher scores indicating greater endoscopic disease severity. Endoscopic response was defined as a >=50% reduction from baseline in SES-CD score or achievement of an SES-CD score <=2 in participants with a baseline SES-CD score >=3.

    Measured: Maintenance Period Week 8 (Study Week 16)

  5. Global Outcome Measure: Percentage of Participants With Clinical Response at Maintenance Week 8

    Clinical response was defined as a reduction from baseline of >=12.5 points in PCDAI score, calculated by summing weighted scores from 11 items across five domains: symptom history(abdominal pain, stool frequency, and general well-being); laboratory scores (hematocrit, erythrocyte sedimentation rate, and albumin); growth scores(weight and height); physical examination scores(abdominal and perirectal disease); extraintestinal manifestations. Each index item was assigned a severity score of 0(normal), 5(mild abnormality), or 10(severe abnormality). For HCT and ESR, maximum score was 5, for albumin level, maximum score was 10. Total PCDAI score ranged from 0 to 100, with higher scores indicating greater disease activity. Lower PCDAI scores reflected lower disease activity, with resulting score of <=30 on 0-100 scale.

    Measured: Maintenance Week 8 (Study Week 16)

  6. Global and US-specific Outcome Measures: Percentage of Participants With Endoscopic Response at Maintenance Week 44 as Assessed by SES-CD

    Endoscopic response was assessed using the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD), a validated endoscopic scoring system based on four components: size of ulcers, extent of ulcerated surface, extent of affected surface, and presence of narrowing. Each component was scored from 0 to 3 across five intestinal sections: ileum, right colon, transverse colon, left (descending and sigmoid) colon, and rectum. Component scores were summed across all sections to derive a total SES-CD score ranging from 0 to 56, with higher scores indicating greater endoscopic disease severity. Endoscopic response was defined as a >=50% reduction from baseline in SES-CD score or achievement of an SES-CD score <=2 in participants with a baseline SES-CD score >=3.

    Measured: Maintenance Week 44 (Study Week 52)

  7. US-specific Outcome Measure: Percentage of Participants With Clinical Response at Maintenance Week 44

    Clinical response was defined as a reduction from baseline of >=12.5 points in PCDAI score, calculated by summing weighted scores from 11 items across five domains: symptom history(abdominal pain, stool frequency, and general well-being); laboratory scores (hematocrit, erythrocyte sedimentation rate, and albumin); growth scores(weight and height); physical examination scores(abdominal and perirectal disease); extraintestinal manifestations. Each index item was assigned a severity score of 0(normal), 5(mild abnormality), or 10(severe abnormality). For HCT and ESR, maximum score was 5, for albumin level, maximum score was 10. Total PCDAI score ranged from 0 to 100, with higher scores indicating greater disease activity. Lower PCDAI scores reflected lower disease activity, with resulting score of <=30 on 0-100 scale.

    Measured: Maintenance Week 44 (Study Week 52)

  8. US-specific Outcome Measure: Percentage of Participants With Corticosteroid-free Clinical Remission at Maintenance Week 44

    Corticosteroid-free remission was defined as PCDAI score of <=10 points and not receiving corticosteroids for at least 90 days prior to Week M-44. The 11-item PCDAI covered five general disease activity domains: symptom history scores (3 items: abdominal pain, stool frequency; and general well-being); laboratory scores (3 items: HCT, ESR, Albumin); growth scores (2 items: weight and height), physical examination scores (2 items: abdomen and perirectal disease), and extraintestinal manifestations. The category of severity for each index item was assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score= 5. For albumin level, the maximum score= 10. All items were summed to derive the total score. The total PCDAI score ranged from 0 to 100, with higher scores indicating greater disease activity.

    Measured: Maintenance Period Week 44 (Study Week 52)

  9. Global Outcome Measure: Percentage of Participants With Clinical Remission at Maintenance Week 44 Who Had Clinical Remission at Induction Week 8

    Clinical remission was defined as Pediatric Crohn's Disease Activity Index (PCDAI) score <=10. The 11-item PCDAI covered five general disease activity domains: symptom history scores (3 items: abdominal pain, stool frequency; and general well-being); laboratory scores (3 items: HCT, ESR, Albumin); growth scores (2 items: weight and height), physical examination scores (2 items: abdomen and perirectal disease), and extraintestinal manifestations. The category of severity for each index item was assigned a score: 0=normal;5=mild abnormality; 10= severe abnormality. For hematocrit and erythrocyte SR, the maximum score= 5. For albumin level, the maximum score= 10. All items were summed to derive the total score. The total PCDAI score ranged from 0 to 100, with higher scores indicating greater disease activity.

    Measured: Maintenance Week 44 (Study Week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start6 Apr 2021
  3. Primary completion28 Nov 2024
  4. Study completion3 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673357
Sponsor's protocol ID
CR108864
Other IDs
CNTO1275CRD3004, 2019-004225-24, 2023-504978-38-00, 2023, 2019
Acronym
UNITI Jr
Status last verified
Jul 2026
First submitted
14 Dec 2020
Last updated
30 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • De Greef E, Turner D, Kierkus J, Korczowski B, Meglicka M, Cohen SA, Hyams JS, Griffiths AM, Rosh JR, Strauss R, Van Limbergen E, Adedokun OJ, Kim L, Volger S; UNITI Jr study Group. Ustekinumab therapy for moderately to severely active pediatric Crohn's disease: UNITI Jr study safety and efficacy results in patients weighing at least 40 kg. J Crohns Colitis. 2026 Mar 10;20(3):jjag011. doi: 10.1093/ecco-jcc/jjag011.

    PubMed 41843763

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 53 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Japan, Germany, Belgium, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Outcome Measure: Percentage of Participants With Clinical Remission at Induction Week 8 (Week I-8) (time frame: Induction Week 8 (Week I-8)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673357, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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