A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease
NCT05028946 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2022-10-20
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).
Conditions
Interventions
- DRUG
-
Foralumab
Foralumab will be administered per dose and schedule specified in the arm description.
Sponsors & Collaborators
-
Tiziana Life Sciences LTD
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-01
- Primary Completion
- 2023-07-07
- Completion
- 2023-11-07
- FDA Drug
- Yes
More Related Trials
-
A Pilot Study of FFP104 in Subjects With Crohn's Disease
NCT02465944 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
NCT04643483 ·Status: WITHDRAWN ·Phase: PHASE3
-
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
NCT03440385 ·Status: COMPLETED ·Phase: PHASE3
-
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
NCT03464097 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)
NCT03559517 ·Status: TERMINATED ·Phase: PHASE3
-
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
NCT03467958 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
NCT00032799 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
NCT02405442 ·Status: TERMINATED ·Phase: PHASE2
-
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
NCT03599622 ·Status: TERMINATED ·Phase: PHASE2
-
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
NCT06754891 ·Status: RECRUITING ·Phase: PHASE1
-
Monoclonal Antibody Treatment of Crohn's Disease
NCT00007163 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut
NCT01275508 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
NCT02403323 ·Status: TERMINATED ·Phase: PHASE3
-
Treatment of Moderate to Severe Refractory Crohn's Disease
NCT06721962 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
NI-0401 in Active Crohn's Disease
NCT00630643 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
NCT03566823 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
NCT00409682 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease
NCT01277666 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
NCT00032786 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
NCT02877134 ·Status: COMPLETED ·Phase: PHASE2
-
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
NCT03759288 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Study of Sargramostim in Moderately to Severely Active Crohn's Disease
NCT00329537 ·Status: TERMINATED ·Phase: PHASE2
-
Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid
NCT04164849 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
NCT00771667 ·Status: COMPLETED ·Phase: PHASE2
-
Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
NCT03059849 ·Status: WITHDRAWN ·Phase: PHASE4