The primary objective is to evaluate the efficacy of V565 555 mg TID in subjects with active CD measured by the proportion of subjects achieving response to therapy. Response is defined as reduction in the Crohn's Disease Activity Index (CDAI)…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of responders at Day 42, defined as subjects achieving both CDAI *70-
point reduction from Baseline OR CDAI score <150, AND a reduction of *40% from
the baseline value of CRP or FCP
Secondary outcome
- Proportion of subjects achieving a *100-point reduction in CDAI score and a
concomitant reduction of 50% in CRP or FCP at Day 42
- Proportion of subjects achieving a *70-point reduction in CDAI score at Day 42
- Proportion of subjects achieving a *100-point reduction in CDAI score at Day
42
- Proportion of subjects achieving a CDAI score of <150 CDAI at Day 42
- Changes from Baseline in scores for PRO-2 at Day 14 and Day 42
Background summary
Crohn*s disease (CD) is characterized by a chronic relapsing progressive course
of intestinal inflammation which is increasing in incidence worldwide. If
disease control is inadequate, the chronic inflammation leads to significant
inflammatory, infectious and structural complications. The complications result
in an increased need for hospitalization and surgery, impaired quality of life,
and disease-related mortality. Persistent and extensive inflammation can even
result in the development of small bowel and colorectal carcinoma.
Currently CD is being treated with parenterally administered TNF* monoclonal
antibodies (e.g. infliximab and adalimumab), which have proven to be able to
affect and improve long-term outcomes. It was found that observational,
subgroup analyses and randomized control trial data, both in adults and in
pediatric populations, indicated that TNF* antagonists are much more effective
when given to patients within 1 to 2 years of their initial diagnosis. For a
number of reasons including the cost of treatment and safety concerns , these
treatments tend to be used late in the management of CD, when much damage has
already occurred in the GI tract.
Study objective
The primary objective is to evaluate the efficacy of V565 555 mg TID in
subjects with active CD measured by the proportion of subjects achieving
response to therapy. Response is defined as reduction in the Crohn's Disease
Activity Index (CDAI) scores and in inflammatory markers CRP or FCP at Day 42.
Study design
This study will be a multiple-site, double-blind, placebo-controlled,
parallel-group proof-of-concept study in approximately 126 subjects with active
CD. This study will include subjects who have a confirmed diagnosis of CD for
at least three months and have CD involving the ileum and/or colon.
Intervention
Each dose will consist of three capsules of V565 (three 185-mg capsules, total
dose 555 mg) or placebo. Study drug will be administered orally TID. The
subjects will be instructed to take the capsules with sufficient fluid one hour
before meals and at least two hours after the previous meal.
No dose adjustments are permitted.
Study burden and risks
This study has been designed to minimize potential risks to subjects. The
exclusion criteria and screening procedures were designed to exclude subjects
who may be at undue risk if they participate in the study.
As this is a proof-of-concept study, there may be no benefit from participation
in the study to an individual subject. However, there is the expectation that
subjects treated with V565 will experience improvements in the symptoms of
their underlying disease.
In summary, the assessment of potential risks associated with V565 in
non-clinical and clinical studies conducted to date support further evaluation
in humans.
This study will be performed in compliance with the protocol, International
Council for Harmonization (ICH), Good Clinical Practice (GCP), and applicable
regulatory requirements.
Lower Court, Copley Hill Business Park, Cambridge Road 1
Cambridge CB22 3GN
GB
Lower Court, Copley Hill Business Park, Cambridge Road 1
Cambridge CB22 3GN
GB
Listed location countries
Age
Inclusion criteria
1. History of CD (confirmed by ileocolonoscopy) of at least three months duration prior to Visit 1
2. CDAI score of *220 to *450 during Screening
3. CRP *5 mg/L (or, if CRP is normal, FCP* 250 *g/g ) at Screening
4. Active CD of ileum and/or colon as determined by the baseline ileocolonoscopy
5. Female subjects must not be pregnant and male and female subjects must agree to use effective contraception throughout the study and for 90 days after the last dose of study drug.
6. Subject must have failed or experienced intolerance to at least one of the following: aminosalicylates, corticosteroids; immunosuppressants
Exclusion criteria
1. CD of mouth, stomach, oesophagus or duodenum which, in the opinion of the Investigator, is likely to be causing symptoms
2. Known history of or suspicion of ulcerative colitis, indeterminate colitis, microscopic colitis, ischaemic co litis or radiation-induced colitis, based on medical history, endoscopy and/or histological findings.
3. Any gastrointestinal (GI) manifestations of CD that might affect the evaluation of efficacy
4. Prior primary efficacy failure of o r secondary loss of response to anti-TNF* therapy, or any contraindication to anti-TNF* therapy
5. The use of medications prior to the study or during the study with the potential to affect the evaluation of efficacy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002939-15-NL |
| ClinicalTrials.gov | NCT02976129 |
| CCMO | NL60562.056.17 |