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

Last Updated May 23, 2025

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CR109074

OVERVIEW

Sexes Eligible for Study
all
Age
2+ years
Phase
phase 3
Sites
42 Sites
Status

Recruiting

SUMMARY

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

CONDITIONS

Crohn's Disease
Colitis, Ulcerative
Arthritis, Psoriatic

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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

Argentina, Belgium, Germany, Hungary, Japan, Poland, United Kingdom, Israel, United States, France, Italy, Spain, Türkiye

Country (13)	City or Province (42)	Status
Argentina	Cordoba Hospital de Ninos de Cordoba	RECRUITING
Argentina	San Miguel De Tucuman Centro de Investigaciones Medicas Tucuman	RECRUITING
Belgium	Bruxelles Huderf	RECRUITING
Belgium	Bruxelles Cliniques Universitaires Saint Luc	RECRUITING
Belgium	Gent UZ Gent	RECRUITING
Belgium	Jette UZ Brussel	RECRUITING
Belgium	Leuven Uz Gasthuisberg	RECRUITING
Germany	Aachen Universitaetsklinikum der RWTH Aachen	RECRUITING
Hungary	Budapest Semmelweis Egyetem	RECRUITING
Hungary	Debrecen Debreceni Egyetem Klinikai Kozpont	RECRUITING
Hungary	Miskolc Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz	RECRUITING
Hungary	Nyiregyhaza Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz	RECRUITING
Hungary	Szeged Szegedi Tudomanyegyetem	RECRUITING
Japan	Bunkyo Ku Juntendo University Hospital	RECRUITING
Japan	Gunma Gunma University Hospital	RECRUITING
Japan	Kurume Kurume University Hospital	RECRUITING
Japan	Saitama shi Saitama Childrens Medical Center	RECRUITING
Japan	Sendai Miyagi Children's Hospital	RECRUITING
Japan	Setagaya Ku National Center for Child Health and Development	RECRUITING
Japan	Tsu Mie University Hospital	RECRUITING
Poland	Rzeszow Korczowski Bartosz Gabinet Lekarski	RECRUITING
Poland	Warszawa Medical Network	RECRUITING
United Kingdom	Birmingham Birmingham Children's Hospital	RECRUITING
United Kingdom	Cambridge Addenbrookes Hospital	RECRUITING
United Kingdom	London Royal London Hospital	RECRUITING
Israel	Jerusalem Shaare Zedek Medical Center	RECRUITING
United States	Atlanta Children's Center For Digestive Healthcare, Llc	ACTIVE_NOT_RECRUITING
United States	Charlotte Levine Childrens at Atrium Health	ACTIVE_NOT_RECRUITING
United States	Fairfax Pediatric Specialists Of Virginia	ACTIVE_NOT_RECRUITING
Argentina	Buenos Aires STAT Research S A	RECRUITING
France	Paris Hôpital Necker	COMPLETED
Germany	Berlin Charite Universitatsmedizin Berlin Campus Virchow Klinikum	RECRUITING
Israel	Beer Yaakov Yitzhak Shamir Medical Center	ACTIVE_NOT_RECRUITING
Israel	Ramat Gan Sheba Medical Center	RECRUITING
Italy	Milano Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano	RECRUITING
Japan	Ikoma Kindai University Nara Hospital	RECRUITING
Poland	Krakow Uniwersytecki Szpital Dzieciecy w Krakowie	RECRUITING
Poland	Torun GASTROMED Sp. z o.o.	RECRUITING
Poland	Warszawa Instytut Pomnik Centrum Zdrowia Dziecka	RECRUITING
Spain	Valencia Hosp. Univ. I Politecni La Fe	RECRUITING
United States	New York Mount Sinai	COMPLETED
Türkiye	Istanbul Cerrahpasa Medical Faculty Hospital	RECRUITING

Geo Locations

-31.4135, -64.18105

-26.82414, -65.2226

50.85045, 4.34878

51.05, 3.71667

50.87309, 4.33419

50.87959, 4.70093

50.77664, 6.08342

47.49801, 19.03991

47.53333, 21.63333

48.1, 20.78333

47.95539, 21.71671

46.253, 20.14824

35.37517, 139.92991

36.52592, 138.97142

33.31667, 130.51667

35.90807, 139.65657

38.26667, 140.86667

35.64825, 139.65376

34.73333, 136.51667

50.04132, 21.99901

52.22977, 21.01178

52.48142, -1.89983

52.2, 0.11667

51.50853, -0.12574

31.76904, 35.21633

33.749, -84.38798

35.22709, -80.84313

38.84622, -77.30637

-34.61315, -58.37723

48.85341, 2.3488

52.52437, 13.41053

31.943507, 34.83904

32.08227, 34.81065

45.46427, 9.18951

34.68333, 135.7

50.06143, 19.93658

53.01375, 18.59814

52.22977, 21.01178

39.46975, -0.37739

40.71427, -74.00597

41.01384, 28.94966

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

-31.4135, -64.18105

-26.82414, -65.2226

50.85045, 4.34878

50.85045, 4.34878

51.05, 3.71667

50.87309, 4.33419

50.87959, 4.70093

50.77664, 6.08342

47.49801, 19.03991

47.53333, 21.63333

48.1, 20.78333

47.95539, 21.71671

46.253, 20.14824

35.37517, 139.92991

36.52592, 138.97142

33.31667, 130.51667

35.90807, 139.65657

38.26667, 140.86667

35.64825, 139.65376

34.73333, 136.51667

50.04132, 21.99901

52.22977, 21.01178

52.48142, -1.89983

52.2, 0.11667

51.50853, -0.12574

31.76904, 35.21633

33.749, -84.38798

35.22709, -80.84313

38.84622, -77.30637

-34.61315, -58.37723

48.85341, 2.3488

52.52437, 13.41053

31.943507, 34.83904

32.08227, 34.81065

45.46427, 9.18951

34.68333, 135.7

50.06143, 19.93658

53.01375, 18.59814

52.22977, 21.01178

39.46975, -0.37739

40.71427, -74.00597

41.01384, 28.94966

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