Phase 2
N=125
A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02976129 ↗Enrolled (actual)
125
Serious AEs
4.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. — 29; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- V565 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VHsquared Ltd.
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. |
20; 9 | — |
| SECONDARY Number of Subjects Achieving Response to Therapy, Defined as Reduction in the CDAI Score and in Inflammatory Markers CRP or FCP at Day 42. |
20; 9 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).
Eligibility Criteria
Inclusion Criteria
- History of Crohn's Disease of at least 3 months duration prior to screening
- Crohn's Disease Activity Index (CDAI) score of ≥220 to ≤450 during screening
- C-reactive protein (CRP) ≥5 mg/L (or, if CRP is normal, faecal calprotectin (FCP) ≥250 µg/g) at screening
- Permitted CD medication regimen expected to remain stable during the period of the study
Exclusion Criteria
- Previous lack of response or current contra-indication to an anti-tumour necrosis factor α (anti-TNFα) agent
- Certain complications of Crohn's Disease that would make it hard to assess response to study drug
- Known history or suspicion of inflammatory bowel disease other than Crohn's disease
- History of tuberculosis (TB) or latent TB infection that has not been treated
- Any significant illness or condition which would preclude effective participation in the study
- GI infection as demonstrated by presence of enteric pathogens
- Pregnant or lactating women
- Abdominal surgery in the previous 6 months
- Unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation
Data sourced from ClinicalTrials.gov (NCT02976129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.