A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions.

• Register: EUCTR
• Last refreshed on: 30 September 2024
• Main ID: EUCTR2020-004457-76-FR
• Date of registration: 27/08/2021
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions.
• Scientific 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) - UNITED
• Date of first enrolment: 09/11/2021
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004457-76
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: basket long term extension (LTE) study If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belgium, France, Germany, Hungary, Italy, Japan, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: - Males or females 2 to <18 years of age, inclusive (at the time of the first administration of study intervention during the LTE). - Must have completed the dosing planned in the primary pediatric ustekinumab study. - Benefit of continued ustekinumab therapy (ie, a clinical response or clinical remission as defined in the primary study at the final efficacy last 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 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 in protocol Appendix 3 (Section 10.3). 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 participate in the study. Please refer to study protocol section 5.1 for full list of inclusion criteria. Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: - 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: may be included with a documented negative result for a validated SARS-CoV-2 test (i) obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, eg, 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 NOTES on COVID-related exclusion: - The field of COVID-related testing (for presence of, and immunity to, the SARS-CoV-2 virus) is rapidly evolving. Additional testing may be performed as part of screening and/or during the study if deemed necessary by the investigator and in accordance with current regulations/guidance from authorities/standards of care Precaution: for those who may carry a higher risk for severe COVID-19 illness, follow guidance from local health authorities when weighing the potential benefits and risks of enrolling in the study, and during participation in the study (protocol Appendix 8 [Section 10.8]). - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, 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 SARS CoV-2 vaccine (against the virus that causes COVID-19) is not automatically an exclusion criterion and must be discussed with the medical monitor. Please refer to study protocol section 5.2 for full list of exclusion criteria.

Age minimum:
Age maximum:
Gender: Female: yes Male: yes

Health Condition(s) or Problem(s) studied

Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0 Level: PT Classification code 10076674 Term: Juvenile psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 200- Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 200-

Primary Outcome(s)

Secondary Objective: Not applicable

Main Objective: Long-term safety data

Timepoint(s) of evaluation of this end point: Enrolment through to end of study participation.

Primary end point(s): - AEs, SAEs, AEs leading to discontinuation of study intervention, and AEs of special interest (as determined for each indication).
- Clinical laboratory hematology and chemistry.
- Injection-site reactions
- AEs of worsening of the disease under study.
- An addition of concomitant therapy due to loss of response.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

CNTO1275ISD3001

Source(s) of Monetary Support

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date: 09/11/2021
Contact:

Results

• Date Posted: 01/01/1900