A Long-term Extension Study of Ustekinumab in Pediatric Participants

Crohn Disease Clinical Trial

— UNITED  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092269
• Other study ID #: CR109074
• Secondary ID: 2020-004457-76CN
• Status: Recruiting
• Phase: Phase 3
• Start date: October 18, 2021
• Est. completion date: September 29, 2027

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 151
• Est. completion date: September 29, 2027
• Est. primary completion date: September 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Colitis, Ulcerative
• Crohn Disease

Intervention

Drug:
• Ustekinumab
Ustekinumab will be administered as a SC injection.

Locations

Country	Name	City	State
Argentina	Hospital de Ninos de Cordoba	Cordoba
Argentina	Centro de Investigaciones Medicas Tucuman	San Miguel De Tucuman
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Huderf	Bruxelles
Belgium	UZ Gent	Gent
Belgium	UZ Brussel	Jette
Belgium	Uz Gasthuisberg	Leuven
France	Hôpital Necker	Paris
Germany	Universitaetsklinikum der RWTH Aachen	Aachen
Germany	Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum	Berlin
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz	Miskolc
Hungary	Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz	Nyiregyhaza
Hungary	Szegedi Tudomanyegyetem	Szeged
Japan	Juntendo University Hospital	Bunkyo Ku
Japan	Gunma University Hospital	Gunma
Japan	Kurume University Hospital	Kurume
Japan	Saitama Childrens Medical Center	Saitama shi
Japan	Miyagi Children's Hospital	Sendai
Japan	National Center for Child Health and Development	Setagaya-ku
Japan	Mie University Hospital	Tsu
Poland	Uniwersytecki Szpital Dzieciecy w Krakowie	Krakow
Poland	Korczowski Bartosz Gabinet Lekarski	Rzeszow
Poland	GASTROMED Sp. z o.o.	Torun
Poland	Instytut Pomnik Centrum Zdrowia	Warszawa
Poland	Medical Network	Warszawa
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	Addenbrookes Hospital	Cambridge
United States	Children's Center For Digestive Healthcare, Llc	Atlanta	Georgia
United States	Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  France,  Germany,  Hungary,  Japan,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	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.	Up to 6 years and 4 months
Primary	Number of Participants With Serious Adverse Events (SAEs)	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.	Up to 6 years and 4 months
Primary	Number of Participants with AEs Leading to Discontinuation of Study Intervention	Number of participants with AEs leading to discontinuation of study intervention will be reported.	Up to 6 years and 4 months
Primary	Number of Participants with AEs of Interest	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.	Up to 6 years and 4 months
Primary	Number of Participants with Abnormalities in Clinical Laboratory Parameters	Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported.	Up to 6 years and 4 months
Primary	Number of Participants with Injection-site Reactions	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.	Up to 6 years and 4 months
Primary	Number of Participants With AEs of Worsening of the Disease	Number of participants with AEs of worsening of the disease will be reported.	Up to 6 years and 4 months
Primary	Number of Participants With Concomitant Therapy due to Loss of Response	Number of participants with concomitant therapy due to loss of response will be reported.	Up to 6 years and 4 months