A Long-term Extension Study of Guselkumab in Pediatric Participants

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Digestive System Diseases [C06]

Trial duration

29 Oct 2024 → ongoing

Decision date (initial)

2026-04-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To evaluate the long-term safety of guselkumab in pediatric participants with moderately to severely active ulcerative colitis (UC), or with moderately to severely active Crohn’s disease, or with juvenile psoriatic arthritis (jPsA)

Conditions and MedDRA coding

Juvenile psoriatic arthritis (jPsA)

Regulatory references

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson&Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Must have completed the dosing planned in the primary pediatric guselkumab study.
2. 2. Received benefit from continued guselkumab therapy in the opinion of the investigator.
3. 3. Before enrollment, a participant must be either: a. not of childbearing potential. OR b. Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure.
4. 4. Parent(s) or their legally designated representative must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is/are willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study. 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 indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
5. 5. Must be willing and able to adhere to the lifestyle restrictions specified in the protocol.

Exclusion criteria 3

1. 1. Is ≥18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication. Is <18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication.
2. 2. Are pregnant, nursing, or planning pregnancy or fathering a child.
3. 3. Taken any disallowed therapies before the planned first LTE dose of study intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. No primary or secondary endpoints will be collected in this study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS Point of Contact

Third parties 4

Locations

8 EU/EEA countries · 23 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 98 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

19 submissions — initial application plus substantial / non-substantial modifications