A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507142-83-00

Acronym

CNTO148UCO3003

Enrollment

Registered

2024-07-31

Start date

2019-01-09

Completion date

2025-02-13

Last updated

2024-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

Clinical remission as assessed by the Mayo score.

Detailed description

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

Interventions

DRUGSimponi 50 mg solution for injection in pre-filled syringe.

DRUGSimponi 45 mg/0.45 mL solution for injection in pre-filled pen.

DRUGSimponi 100 mg solution for injection in pre-filled syringe.

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Secondary

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

Primary

Measure	Time frame
Clinical remission as assessed by the Mayo score.	—

Countries

France, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026