A Phase 2a Multicenter, Randomized, Open Label, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease

Research summary

This is a Phase 2a PoC, treat-through, multicenter, randomized, open label, platform study in CD subjects. This platform study is designed as a series of "intervention sets" that will run in parallel but may not be initiated at the same time. Each intervention set will include 1 or more treatment arms depending on the objective of the intervention set. In addition, 1 treatment arm will be incorporated as a common comparator arm across other intervention sets. Additional "intervention sets" and/or different "comparator arms" can be added subsequently, as per the platform concept. The general sections (Section 1 through Section 21) describe the framework for the common study elements of the platform study. The accompanying ISSA(s) (Section 14, Section 22, and Section 23) will present the intervention-specific information. The appendix for randomization schedule (Section 13) describes the details of the randomization schedule following the initiation/completion of enrollment of any of the treatment arms or other updates. The details of the LTE Period are described in Section 15. Subjects will be equally randomized (e.g., 1:1:1:1:1 ratio) among all actively enrolling treatment arms. If additional intervention set(s) are added or enrollment of existing ones are completed, the randomization schedule will be updated accordingly, and subjects will be randomized in equal allocation to active treatment arms following the updated schedule.

Principal Investigator

Dr Oliver Brain

Contact us

Email: ctf.research@ouh.nhs.uk

IRAS number

1010281