Psoriasis Clinical Trial

A Long-term Extension Study of Ustekinumab in Pediatric Participants

Summary

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

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

151

Study ID:

NCT05092269

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 31 Locations for this study

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Children's Center For Digestive Healthcare, Llc
Atlanta Georgia, 30342, United States
Mount Sinai
New York New York, 10029, United States
Hospital de Ninos de Cordoba
Cordoba , X5014, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel De Tucuman , T4000, Argentina
Huderf
Bruxelles , 1020, Belgium
Cliniques Universitaires Saint Luc
Bruxelles , 1200, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Brussel
Jette , 1090, Belgium
Uz Gasthuisberg
Leuven , 3000, Belgium
Hôpital Necker
Paris , 75015, France
Universitaetsklinikum der RWTH Aachen
Aachen , 52074, Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin , 13353, Germany
Semmelweis Egyetem
Budapest , 1083, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc , 3526, Hungary
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyiregyhaza , 4400, Hungary
Szegedi Tudomanyegyetem
Szeged , 6720, Hungary
Juntendo University Hospital
Bunkyo Ku , 113 8, Japan
Gunma University Hospital
Gunma , 371-0, Japan
Kurume University Hospital
Kurume , 830-0, Japan
Saitama Childrens Medical Center
Saitama shi , 330-8, Japan
Miyagi Children's Hospital
Sendai , 989-3, Japan
National Center for Child Health and Development
Setagaya Ku , 157 8, Japan
Mie University Hospital
Tsu , 514 8, Japan
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow , 30-66, Poland
Korczowski Bartosz Gabinet Lekarski
Rzeszow , 35-30, Poland
GASTROMED Sp. z o.o.
Torun , 87-10, Poland
Medical Network
Warszawa , 04-50, Poland
Instytut Pomnik Centrum Zdrowia
Warszawa , 04-73, Poland
Birmingham Children's Hospital
Birmingham , B4 6N, United Kingdom
Addenbrookes Hospital
Cambridge , Cb2 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

151

Study ID:

NCT05092269

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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