UNITED: A Long-term Extension Study of Ustekinumab in Pediatric Participants

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05092269

Collaborator

(none)

151

Enrollment

Locations

Arm

74.4

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease Colitis, Ulcerative Arthritis, Psoriatic	Drug: Ustekinumab	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

151 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)

Actual Study Start Date :

Oct 18, 2021

Anticipated Primary Completion Date :

Sep 29, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ustekinumab 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.	Drug: Ustekinumab Ustekinumab will be administered as a SC injection. Other Names: STELARA

Arm

Intervention/Treatment

Experimental: Ustekinumab

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.

Drug: Ustekinumab

Ustekinumab will be administered as a SC injection.

Other Names:

STELARA

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) [Up to 6 years and 4 months]
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) [Up to 6 years and 4 months]
A SAE is 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; congenital anomaly.
Number of Participants with AEs Leading to Discontinuation of Study Intervention [Up to 6 years and 4 months]
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Number of Participants with AEs of Interest [Up to 6 years and 4 months]
Number of participants with AEs of special interest (any newly identified malignancy case of active tuberculosis [TB], or opportunistic infection occurring after the first administration of study intervention[s]) will be reported.
Number of Participants with Abnormalities in Clinical Laboratory Parameters [Up to 6 years and 4 months]
Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported.
Number of Participants with Injection-site Reactions [Up to 6 years and 4 months]
Number of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
Number of Participants With AEs of Worsening of the Disease [Up to 6 years and 4 months]
Number of participants with AEs of worsening of the disease will be reported.
Number of Participants With Concomitant Therapy due to Loss of Response [Up to 6 years and 4 months]
Number of participants with concomitant therapy due to loss of response will be reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must have completed the dosing planned in the primary pediatric ustekinumab study
Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)
Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration

Exclusion Criteria:

Are pregnant, nursing, or planning pregnancy or fathering a child
Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 [COVID-19]) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection: Exception: (i) may be included with a documented negative result for a validated SARS-CoV-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit
Taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (LTE) dose of study intervention
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. Receipt of a live severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine (against the virus that causes Coronavirus Disease 2019 [COVID-19]) is not automatically an exclusion criterion and must be discussed with the medical monitor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Center For Digestive Healthcare, Llc	Atlanta	Georgia	United States	30342
2	Mount Sinai	New York	New York	United States	10029
3	Cliniques Universitaires Saint-Luc	Brussel		Belgium	1200
4	Huderf	Bruxelles		Belgium	1020
5	UZ Gent	Gent		Belgium	9000
6	UZ Brussel	Jette		Belgium	1090
7	Uz Gasthuisberg	Leuven		Belgium	3000
8	Hôpital Necker	Paris		France	75015
9	Universitaetsklinikum der RWTH Aachen	Aachen		Germany	52074
10	Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum	Berlin		Germany	13353
11	Universitatsklinikum Essen	Essen		Germany	48147
12	Dr. von Haunersches Kinderspital	München		Germany	80337
13	Universitätsklinikum Ulm	Ulm		Germany	89075
14	Semmelweis Egyetem	Budapest		Hungary	1083
15	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
16	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc		Hungary	3526
17	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz	Nyíregyháza		Hungary	4400
18	Szegedi Tudomanyegyetem	Szeged		Hungary	6720
19	Juntendo University Hospital	Bunkyo-Ku		Japan	113-8431
20	Gunma University Hospital	Gunma		Japan	371-0034
21	National Center for Child Health and Development	Setagaya-ku		Japan	157-8535
22	Uniwersytecki Szpital Dzieciecy w Krakowie	Krakow		Poland	30-663
23	Gabinet Lekarski Bartosz Korczowski	Rzeszow		Poland	35-302
24	WIP Warsaw IBD Point Profesor Kierkus	Warszawa		Poland	00-728
25	Instytut Pomnik - Centrum Zdrowia	Warszawa		Poland	04-730

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT05092269

Other Study ID Numbers:

CR109074
2020-004457-76
CNTO1275ISD3001

First Posted:

Oct 25, 2021

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022