Clinical trial NCT05092269: A Long-term Extension Study of Ustekinumab in Pediatric Participants
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crohn Disease
Colitis, Ulcerative
Arthritis, Psoriatic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 151
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 6 years and 4 months
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 6 years and 4 months
measure: Number of Participants with AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to 6 years and 4 months
measure: Number of Participants with AEs of Interest
timeFrame: Up to 6 years and 4 months
measure: Number of Participants with Abnormalities in Clinical Laboratory Parameters
timeFrame: Up to 6 years and 4 months
measure: Number of Participants with Injection-site Reactions
timeFrame: Up to 6 years and 4 months
measure: Number of Participants With AEs of Worsening of the Disease
timeFrame: Up to 6 years and 4 months
measure: Number of Participants With Concomitant Therapy due to Loss of Response
timeFrame: Up to 6 years and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Center For Digestive Healthcare, Llc
state: Georgia
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Charlotte
country: United States
facility: Levine Childrens at Atrium Health
state: North Carolina
city: Fairfax
country: United States
facility: Pediatric Specialists Of Virginia
state: Virginia
city: Buenos Aires
country: Argentina
facility: STAT Research S A
city: Cordoba
country: Argentina
facility: Hospital de Ninos de Cordoba
city: San Miguel De Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: Bruxelles
country: Belgium
facility: Huderf
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Jette
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: Uz Gasthuisberg
city: Paris
country: France
facility: Hôpital Necker
city: Aachen
country: Germany
facility: Universitaetsklinikum der RWTH Aachen
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin Campus Virchow Klinikum
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Miskolc
country: Hungary
facility: Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Beer Yaakov
country: Israel
facility: Yitzhak Shamir Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
city: Bunkyo Ku
country: Japan
facility: Juntendo University Hospital
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Ikoma
country: Japan
facility: Kindai University Nara Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Saitama shi
country: Japan
facility: Saitama Childrens Medical Center
city: Sendai
country: Japan
facility: Miyagi Children's Hospital
city: Setagaya Ku
country: Japan
facility: National Center for Child Health and Development
city: Tsu
country: Japan
facility: Mie University Hospital
city: Krakow
country: Poland
facility: Uniwersytecki Szpital Dzieciecy w Krakowie
city: Rzeszow
country: Poland
facility: Korczowski Bartosz Gabinet Lekarski
city: Torun
country: Poland
facility: GASTROMED Sp. z o.o.
city: Warszawa
country: Poland
facility: Instytut Pomnik Centrum Zdrowia Dziecka
city: Warszawa
country: Poland
facility: Medical Network
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: