RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Guselkumab for Crohns Disease

Q: Is NCT06663332 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT06663332?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT06663332?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This study wants 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).

Official registry: https://clinicaltrials.gov/study/NCT06663332 · Janssen Research & Development, LLC · enrollment listed as 196

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Guselkumab. The registry lists allocation as randomized. This study wants 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).

They plan to enroll about 196 people at 53 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

Interventions: Guselkumab

Primary outcome (registry wording): Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety

Who it is for (from inclusion criteria)

Ages 3 Years to any
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

Who the registry excludes

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 the respective adult indication
Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication
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 or study site, as well as family members of the employees or the 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 prevent, limit, or confound the protocol-specified assessments

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

53 listed

Emory University — Atlanta, Georgia (recruiting)
Children's Center for Digestive Healthcare — Atlanta, Georgia (recruiting)
Riley Hospital for Children — Indianapolis, Indiana (recruiting)
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio (recruiting)
Cook Childrens Medical Center — Fort Worth, Texas (recruiting)
University of Utah — Salt Lake City, Utah (recruiting)

+ 47 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06663332 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06663332?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06663332?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary