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

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ClinicalTrials.gov Identifier: NCT04673357
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Ustekinumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Induction period is an open-label period and maintenance period is a double-blind period.
Primary Purpose: Treatment
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
Estimated Study Start Date : March 16, 2021
Estimated Primary Completion Date : July 24, 2025
Estimated Study Completion Date : July 25, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Experimental: Open- Label Ustekinumab Intravenous (IV): Induction Period
All Participants will receive a single, open-label IV ustekinumab induction dose at induction week 0 (Week I-0). For participants with body weight less than (<) 40 kilograms (kg) dosing will be body surface area (BSA)-adjusted: ustekinumab 250 milligram per meter square (mg/m^2). For participants with body weight greater than or equal to (>=) 40 kg dosing will be based on a weight-tiered as follows: at 260 milligram (mg) dose for >= 40 kg to less than or equal to (<=) 55 kg body weight; at 390 mg dose for greater than (>) 55 kg to <= 85 kg body weight; and at 520 mg dose for > 85 kg body weight.
Drug: Ustekinumab
Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

Experimental: Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance Period
Participants with >= 40 kg body weight will receive 90 mg and with < 40 kg body weight will receive 60 mg/m^2 SC ustekinumab 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 once every 8 week.
Drug: Ustekinumab
Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

Drug: Placebo
Matching placebo will be administered as SC injection.

Experimental: Ustekinumab SC Every 12 Weeks (q12w): Maintenance Period
Participants with >= 40 kg body weight will receive 90 mg and with < 40 kg body weight will receive 60 mg/m^2 SC ustekinumab at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 once every 8 week.
Drug: Ustekinumab
Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

Drug: Placebo
Matching placebo will be administered as SC injection.




Primary Outcome Measures :
  1. Number of Participants with Clinical Remission at Induction Week 8 [ Time Frame: Week 8 ]
    Number of participants with clinical remission in induction period will be assessed. Clinical remission is defined as having a Pediatric Crohn's Disease Activity Index (PCDAI) score less than or equal to (<=) 10 points. PCDAI is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdominal tenderness or mass, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease.

  2. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Week 74 ]
    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.

  3. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Week 74 ]
    A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

  4. Number of Participants with AEs leading to Discontinuation of Study Intervention [ Time Frame: Up to Week 74 ]
    Number of participants with AEs leading to discontinuation of study intervention will be reported.

  5. Number of Participants with AEs of Interest [ Time Frame: Up to Week 74 ]
    Number of participants with AEs of interest (any newly identified malignancy, or case of active tuberculosis [TB], or opportunistic infection occurring after the first administration of study intervention[s]) will be reported.

  6. Number of Participants with Abnormalities in Clinical Laboratory Parameters [ Time Frame: Up to Week 52 ]
    Number of participants with abnormalities in clinical laboratory parameters (such as hematology and chemistry) will be reported.

  7. Number of Participants with Reactions Temporally Associated with Intravenous (IV) Infusion (Induction Period) [ Time Frame: Up to Week 8 (Induction period) ]
    Number of participants with reactions temporally associated with IV infusion in induction period will be reported.

  8. Number of Participants with Subcutaneous (SC) Injection-Site Reactions (Maintenance Period) [ Time Frame: Up to Week 44 (Maintenance period) ]
    Number of participants with SC injection-site reactions in maintenance period will be reported.

  9. Serum Ustekinumab Concentrations [ Time Frame: Up to Week 52 ]
    Serum ustekinumab concentrations will be reported.

  10. Number of Participants with Clinical Remission at Maintenance Week 44 [ Time Frame: Week 44 (Maintenance Period) ]
    Number of participants with clinical remission in maintenance period will be assessed. This will be assessed among participants who are in clinical response at induction week-8 (I-8). Clinical remission is defined as having a PCDAI score <= 10 points. PCDAI is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdominal tenderness or mass, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease.


Secondary Outcome Measures :
  1. Number of Participants with Clinical Remission [ Time Frame: Week 6 (Induction period) ]
    Number of participants with clinical remission in induction period will be reported. Clinical remission is defined as PCDAI score and short Pediatric Crohn's Disease Activity Index (sPCDAI) score <= 10 points.

  2. Number of Participants with Clinical Response [ Time Frame: Week 8 (Induction period) ]
    Number of participants with clinical response in induction period will be reported. Clinical response is defined as a reduction from baseline in the PCDAI score of greater than or equal to (>=) 12.5 points with a total PCDAI score not more than 30.

  3. Number of Participants with Clinical Response [ Time Frame: Week 6 (Induction period) ]
    Number of participants with clinical response in induction period will be reported.

  4. Number of Participants with Endoscopic Response [ Time Frame: Week 8 (Maintenance period) ]
    Number of participants with endoscopic response in maintenance period will be reported. Endoscopic response is defined as a reduction in the simplified endoscopic score-Crohn's disease (SES-CD) score of >= 50 percent (%) or SES-CD score <= 2 in participants with a baseline SES-CD score of >= 3. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 to 60).

  5. Number of Participants with Clinical Response [ Time Frame: Week 8 (Maintenance period) ]
    Number of participants with clinical response in maintenance period will be reported.

  6. Number of Participants with Clinical Remission [ Time Frame: Week 44 (Maintenance period) ]
    Number of participants with clinical remission in maintenance period will be reported.

  7. Number of Participants with Endoscopic Response [ Time Frame: Week 44 (Maintenance period) ]
    Number of participants with endoscopic response in maintenance period will be reported.

  8. Number of Participants with Clinical Response [ Time Frame: Week 44 (Maintenance period) ]
    Number of participants with clinical response in maintenance period will be reported.

  9. Number of Participants with Corticosteroid-free Clinical Remission [ Time Frame: Week 44 (Maintenance period) ]
    Number of participants with corticosteroid-free clinical remission in maintenance period will be reported. Corticosteroid-free clinical remission is PCDAI score <= 10 points and not receiving corticosteroids for at least 90 days prior to Week 44.

  10. Number of Participants with Corticosteroid-free Clinical Response [ Time Frame: Week 44 (Maintenance period) ]
    Number of participants with corticosteroid-free clinical response in maintenance period will be reported. Corticosteroid-free clinical response is a reduction from baseline in the PCDAI score of >= 12.5 points with a total PCDAI score not more than 30 and not receiving corticosteroids for at least 90 days prior to Week 44.

  11. Number of Participants with Durable Clinical Remission [ Time Frame: Week 44 (Maintenance period) ]
    Number of participants with durable clinical remission in maintenance period will be reported. Durable clinical remission is PCDAI score <=10 points for >= 80% of all maintenance visits between Week M-8 to Week M-44 and in clinical remission at Week M-44.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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. 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 serum pregnancy test (beta-human chorionic gonadotropin) at screening, and then have a negative urine pregnancy test at Week I-0 prior to study intervention administration

Exclusion Criteria:

  • 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, including TB, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673357


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04673357    
Other Study ID Numbers: CR108864
2019-004225-24 ( EudraCT Number )
CNTO1275CRD3004 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Pediatric
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents