NCT05028946

A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease

A Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's Disease

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tiziana Life Sciences LTD · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to establish the safety and tolerability of multiple ascending doses (MAD) of foralumab enteric coated capsules administered orally, once daily for 5 days per week over 2 weeks in participants with moderate to severely active Crohn's Disease (CD).

Detailed description

Four different doses of foralumab enteric coated capsules will be studied for safety and tolerability in a MAD format. Participants in the sequential MAD cohorts will receive treatment when the safety data of one cohort are reviewed by the Data Safety Monitoring Board (DSMB) and are deemed favorable to proceed with the next treatment in the subsequent cohort.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Foralumab	Foralumab will be administered per dose and schedule specified in the arm description.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-07-07
• Completion: 2023-11-07
• First posted: 2021-08-31
• Last updated: 2022-10-20

Regulatory

• FDA-regulated drug study