A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International, Janssen Biologics B.V.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

9 Jan 2019 → 13 Feb 2025

Decision date (initial)

2024-07-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-507142-83-00

EudraCT number

2017-004496-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

1. To evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active UC.
2. To evaluate the safety profile of golimumab, in pediatric participants with moderately to severely active UC.

Secondary objectives 5

1. To evaluate the efficacy of golimumab in inducing clinical response as assessed by the Mayo Score and clinical remission as measured by the PUCAI Score.
2. To evaluate the efficacy of golimumab on endoscopic healing.
3. To evaluate the efficacy of golimumab during the long-term phase.
4. To evaluate the effect of golimumab on additional efficacy and quality of life (QOL) measures
5. To evaluate the PK and exposure response of golimumab during shortand long-term phases.

Conditions and MedDRA coding

Ulcerative Colitis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-000265-PIP02-11

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. Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis [UC]) OR required more than 3 courses of D129corticosteroids in the past year
2. Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (>=2)
3. If receiving parenteral or enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Participants who receive parenteral nutrition are not permitted to enroll in the trial.
4. No history of latent or active tuberculosis prior to screening
5. Acceptable evidence of immunity to measles, mumps, rubella, and varicella

Exclusion criteria 6

1. History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances
2. History of malignancy or macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
3. Have UC limited to the rectum only or to <20 percent (%) of the colon
4. Presence of a stoma
5. Presence or history of a fistula
6. Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical remission as assessed by the Mayo score.

Secondary endpoints 7

1. 1. Clinical response as assessed by the Mayo score.
2. 2. Clinical remission as assessed by the PUCAI score.
3. 3. Endoscopic healing.
4. 4. Clinical remission as assessed by the PUCAI score.
5. 5. Endoscopic healing.
6. 6. Rémission symtomatologique.
7. 7. Clinical remission as assessed by the Mayo score.

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

Janssen Biologics B.V.

Sponsor organisation

Janssen Biologics B.V.

Address

Einsteinweg 101, P. O. Box 251 P. O. Box 251

City

Leiden

Postcode

2333 CB

Country

Netherlands

Scientific contact point

Organisation

Janssen Biologics B.V.

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen Biologics B.V.

Contact name

CTIS Point of Contact

Third parties 9

Locations

3 EU/EEA countries · 5 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 9 files

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

Application history

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