A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib with Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects with Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509618-12-00

Acronym

M14-671

Enrollment

Registered

2024-08-05

Start date

2024-09-11

Completion date

Unknown

Last updated

2026-01-06

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

Conditions

Crohn's Disease (CD)

Brief summary

Achievement of clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) in the participants who achieved clinical response per PCDAI at Week 12, Achievement of endoscopic response in participants who achieved clinical response per PCDAI at Week 12., Number of Participants with Adverse Events

Detailed description

Achievement of clinical remission per PCDAI at week 12, Achievement of endoscopic response at week 12, Achievement of endoscopic remission at week 12, Achievement of clinical response per PCDAI at week 12, Achievement of clinical response per PCDAI at week 64 in participants who achieved clinical response per PCDAI at Week 12, Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12, Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12

Interventions

DRUGCIPROFLOXACIN

DRUGUpadacitinib

DRUGMETHOTREXATE

DRUGSULFASALAZINE

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Achievement of clinical remission per the Pediatric Crohn's Disease Activity Index (PCDAI) in the participants who achieved clinical response per PCDAI at Week 12, Achievement of endoscopic response in participants who achieved clinical response per PCDAI at Week 12., Number of Participants with Adverse Events	—

Secondary

Measure	Time frame
Achievement of clinical remission per PCDAI at week 12, Achievement of endoscopic response at week 12, Achievement of endoscopic remission at week 12, Achievement of clinical response per PCDAI at week 12, Achievement of clinical response per PCDAI at week 64 in participants who achieved clinical response per PCDAI at Week 12, Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12, Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12	—

Measure

Time frame

—

Countries

Belgium, Bulgaria, France, Greece, Italy, Poland, Spain

Outcome results

None listed

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