drugset / Trial / NCT05299931
An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study
Phase 3
Active not recruiting
108 enrolled
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Janssen Cilag N.V./S.A. · collab
Non-randomizedCrossoverOpen-labelTreatment
Summary
The aim of the study is to assess the long-term efficacy and safety of a ustekinumab 90mg subcutaneous (SC) every 4 weeks (Q4w) regimen in patients with Crohn's disease previously enrolled in the REScUE study (NCT04245215) because of secondary loss of response to a ustekinumab 90mg SC every 8 weeks (Q8w) regimen.
Timeline
- Start
- 2021-09-10
- Primary completion
- 2026-06
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Subcutaneous |