A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC) (UNIFI Jr)
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| ClinicalTrials.gov Identifier: NCT04630028 |
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Recruitment Status :
Recruiting
First Posted : November 16, 2020
Last Update Posted : March 19, 2021
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief Summary:
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active UC.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colitis, Ulcerative | Drug: Ustekinumab Dose Based on BSA and Body Weight Drug: Matching Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| 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 Ulcerative Colitis |
| Actual Study Start Date : | March 15, 2021 |
| Estimated Primary Completion Date : | July 24, 2025 |
| Estimated Study Completion Date : | July 24, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
Drug Information available for:
Ustekinumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Induction Period (I): Ustekinumab
All participants will receive a single intravenous (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]).
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Drug: Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Other Name: STELARA |
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Experimental: Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Participants will receive subcutaneous (SC) administration of ustekinumab every 8 weeks (q8w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-8, M-16, M-24, M-32, M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.
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Drug: Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Other Name: STELARA Drug: Matching Placebo Placebo will be administered subcutaneously. |
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Experimental: Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)
Participants will receive SC administration of ustekinumab every 12 weeks (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.
|
Drug: Ustekinumab Dose Based on BSA and Body Weight
As per BSA and body weight Ustekinumab will be administered SC and IV.
Other Name: STELARA Drug: Matching Placebo Placebo will be administered subcutaneously. |
Primary Outcome Measures :
- Global: Number of Participants with Clinical Remission at Induction Week 8 (I-8) Visit [ Time Frame: Week 8 ]Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 74 weeks ]An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
- Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 74 weeks ]SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
- Number of Participants with AEs Leading to Discontinuation of Study Intervention [ Time Frame: Up to 74 weeks ]Number of Participants with discontinuation of study intervention due to an AE, infections, injection-site reactions, and AEs during or within 1 hour of an infusion will be reported.
- Number of Participants with AEs of Special Interest (AESI) as a Measure of Safety and Tolerability [ Time Frame: Up to 74 weeks ]AESI of any newly identified malignancy, case of active tuberculosis (TB), or opportunistic infection occurring after the first administration of study intervention(s) in participants will be reported.
- Number of Participants with Laboratory Abnormalities [ Time Frame: Up to 74 weeks ]Number of participants with laboratory abnormalities related to hematology, serum chemistry, and coagulation will be reported.
- Reactions Temporally Associated with an Intravenous (IV) Infusion and Subcutaneous (SC) Injection-site Reactions [ Time Frame: Up to 74 weeks ]Reactions temporally associated with an IV infusion (induction period) and SC injection-site reactions (maintenance period) will be reported.
- Serum Concentration of Ustekinumab [ Time Frame: Up to 74 weeks ]Serum samples will be analyzed to determine concentrations of ustekinumab.
- US Specific: Clinical Remission at M-44 for Participants who are in Clinical Response at I-8 [ Time Frame: Week 52 ]Clinical remission at M-44 for participants who are in clinical response at I-8 will be reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Secondary Outcome Measures :
- Number of Participants With Clinical Response at I-8 Visit [ Time Frame: Week 8 ]Clinical response is defined as decrease from baseline in the modified Mayo score by >= 30 percent (%) and >=2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.
- Number of Participants with Symptomatic Remission at I-8 Visit [ Time Frame: Week 8 ]Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
- Clinical Remission at I-8 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score [ Time Frame: Week 8 ]Clinical remission is defined as a PUCAI score less than (<)10.
- Endoscopic Improvement at I-8 Visit [ Time Frame: Week 8 ]Endoscopic improvement is defined as a Mayo endoscopy subscore of 0 or <= 1 with no friability present on the endoscopy.
- Number of Participants with Clinical Remission at Week 44 (M-44) Visit [ Time Frame: Week 52 ]Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
- Number of Participants with Symptomatic Remission at M-44 Visit [ Time Frame: Week 52 ]Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
- Clinical Remission at M-44 as Assessed by the PUCAI Score [ Time Frame: Week 52 ]Clinical remission is defined as a PUCAI score less than < 10.
- Endoscopic Improvement at M-44 Visit [ Time Frame: Week 52 ]Endoscopic improvement is defined as a Mayo endoscopy subscore of 0 or <= 1 with no friability present on the endoscopy.
- Clinical Remission at M-44 and not Receiving Corticosteroids for at Least 90 Days Prior to M-44 Among Participants who Received Corticosteroids at M-0 [ Time Frame: Week 52 ]Clinical remission is defined as a PUCAI score less than < 10. Clinical remission at M-44 and in participants not receiving corticosteroids for at least 90 days prior to M-44 among participants who received corticosteroids at M-0 as assessed by PUCAI score will be reported.
- Clinical Remission at M-44 for Participants who are in Clinical Remission at I-8 [ Time Frame: Week 52 ]Clinical remission at M-44 for participants who are in clinical remission at I-8 will be reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
- US Specific: Number of Participants with Clinical Remission at I-8 Visit [ Time Frame: Week 8 ]Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
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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:
- 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 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:
- 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, including tuberculosis (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
- Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients
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): NCT04630028
Contacts
| Contact: Study Contact | 844-434-4210 | JNJ.CT@sylogent.com |
Locations
Show 56 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Additional Information:
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT04630028 |
| Other Study ID Numbers: |
CR108865 2019-004224-38 ( EudraCT Number ) CNTO1275PUC3001 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | November 16, 2020 Key Record Dates |
| Last Update Posted: | March 19, 2021 |
| Last Verified: | March 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/clinicaltrials/ 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases Ustekinumab Dermatologic Agents |