TRILOGY
Research type
Research Study
Full title
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
IRAS ID
1013158
Contact name
Elena Bolanos Cascales
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2023-509560-16
ISRCTN Number
ISRCTN37514492
Research summary
UC is a disease of the large intestine where the lining of the colon (part of large intestine) becomes inflamed and develops tiny open ulcers. CD is a disease of the digestive system that causes inflammation and ulcers in the intestine. jPsA is a disease that causes inflammation and pain in the joints along with rashes in children.
Participants who have received benefit from guselkumab therapy during the primary studies will be provided continued access to it, as per investigator’s decision.
Guselkumab is a medicine that blocks interleukin-23 (IL-23, specific type of protein involved in inflammation). Blocking the effects of IL-23 helps to reduce the inflammation.
This study is to assess the long-term safety of guselkumab in children with moderate to severe UC, CD and jPsA.
Paediatric participants with UC, CD and jPsA who benefited in 1 of the 3 primary studies: (CNTO1959PUC3001, CNTO1959PBCRD3007, CNTO1275JPA3001).
Participants will be assigned to 1 of 2 arms:
1.Guselkumab once every 8 weeks (q8w):
a. Participants from double-blinded *arm of primary studies (CNTO1959PUC3001 and CNTO1959PBCRD3007) will receive q8w dosing and may get an option to switch to once every 4 weeks (q4w) dosing as per investigator’s decision. Participants from CNTO1275JPA3001 primary study will continue the same dosing regimen (q8w). Dose changes are not allowed for the q8w arm.
*Neither participants nor sponsor know which study treatment is given
b. Guselkumab q4w: Participants from open label **arm of primary studies (CNTO1959PUC3001 and CNTO1959PBCRD3007) will receive q4w dosing. Participants from CNTO1275JPA3001 primary study will continue the same dosing regimen (q4w). Dose changes are not allowed for the q4w arm.
**Participants and sponsor both know which study treatment is given
Safety assessments include laboratory tests, physical examinations, vital signs, suicidal thought and behaviour monitoring. All side effects will be measured until study ends (around 7 years).REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0403
Date of REC Opinion
26 Jan 2026
REC opinion
Further Information Favourable Opinion