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New treatment option for Crohns Disease
Official title A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
ClinicalTrials.gov ID: NCT06663332
What this study is testing
What is Guselkumab?
Guselkumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohns disease.
Also referred to as CNTO1959.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- Must have completed the dosing planned in the primary pediatric guselkumab study
- Must have received benefit from continued guselkumab therapy in the opinion of the investigator
- Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active...
- Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of...
You likely can't join if
- Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for...
- Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric...
- Are pregnant, nursing, or planning pregnancy or fathering a child
- Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
- Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator...
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Cincinnati, Ohio, United States
- Salt Lake City, Utah, United States
- Rosario, Argentina
- Nedlands, Australia
- South Brisbane, Australia
- Westmead, Australia
- Goiânia, Brazil
- Beijing, China
- Changzhou, China
- Hangzhou, China
- Shanghai, China
- Shenyang, China
- Lille, France
- Hamburg, Germany
- Sankt Augustin, Germany
- Bergamo, Italy
- Bologna, Italy
- Roma, Italy
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Indianapolis, Indiana, United States; Cincinnati, Ohio, United States; Salt Lake City, Utah, United States; Rosario, Argentina; Nedlands, Australia and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.