Primary: assess the effect of tralokinumab compared with placebo in patients with active ulcerative colitis by assessment of clinical response, as defined by the Mayo score, at week 8.Other objectives: assess the change in (partial) Mayo scores…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is clinical response, defined as a decrease in Mayo
score from baseline of at least 3 points and at least 30% with an accompanying
decrease in the sub score for rectal bleeding of at least 1 point or absolute
sub score for rectal bleeding of 0 or 1.
Secondary outcome
-Change from baseline in Mayo score
-Mucosal healing, defined as an improvement of the endoscopy subscore (from the
Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points
-Change from baseline in partial Mayo score
-Clinical remission, defined as Mayo score of 2 or lower with no individual
subscore exceeding 1 point
-Histologic disease activity: modified Riley score
-Markers of disease activity and intestinal leakiness in serum and faeces: CRP
and albumin (in serum), calprotectin (in faeces)
-Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in
serum
-Plasma pharmacokinetics (PK) parameters
-Safety measurements
Background summary
Moderate to severe ulcerative colitis represents an area of unmet medical need
as currently available therapies frequently fail to prevent significant
morbidity and mortality. Long-term studies indicate that approximately 50% of
ulcerative colitis patients relapse in any given year, what has a considerable
impact on patients' quality of life and their use of healthcare resources.
Tralokinumab has been shown to be a potentially safe and efficacious therapy
for moderate to severe asthma. Tralokinumab targets IL-13 and IL-13 has been
implicated in the pathogenesis of ulcerative colitis. This study will evaluate
if tralokinumab has potential as a novel therapy for ulcerative colitis when
added to standard therapies.
Study objective
Primary: assess the effect of tralokinumab compared with placebo in patients
with active ulcerative colitis by assessment of clinical response, as defined
by the Mayo score, at week 8.
Other objectives: assess the change in (partial) Mayo scores throughout the
study, assess mucosal healing at week 8, assess markers of disease activity and
intestinal leakiness in serum and faeces, assess pharmacokinetics and
immunogenicity of tralokinumab, evaluate safety and tolerability.
Study design
Randomised, double-blind, placebo controlled, phase IIa study to compare
tralokinumab (300 mg sc) with placebo.
The study lasts 25 weeks for every patient and consists of 11 visits: a
screenings visit, 7 treatment visits every other week and 3 follow-up visits
every 4 weeks.
About 110 patients will participate in the study in about 40 centres in 8
European countries. In the Netherlands, about 12 patients will be enrolled in
about 4 centres.
First subject in is planned for 15 February 2012 and last subject last visit is
planned for 4 February 2013.
Intervention
Tralokinumab (CAT-354, a human anti interleukin 13 (IL-13) monoclonal antibody)
300 mg or placebo will be administered as 2 sc 150 mg injections every 2 weeks
during a 12 week period.
Tralokinumab or placebo is given as add-on therapy to the standard treatment of
ulcerative colitis.
Study burden and risks
Tralokinumab has been studied in a limited number of people and therefore it's
side effects may not be fully known at this time. The side effects reported in
6 clinical studies with tralokinumab in asthma patients were:
-asthma
-signs of infection in the urine
-low blood levels of cells that fight infection
-cold-like symptoms (sore throat, coagh, headache)
-feeling tired
-diarrhoea
-tootache
-pain on injection site
-acute hypersensitivity reaction
Patients can experience discomfort during the assessments of this study (for
example during taking blood samples and during endoscopy and biopsy
collections)
Louis Pasteurlaan 5
Zoetermeer 2719 EE
NL
Louis Pasteurlaan 5
Zoetermeer 2719 EE
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosed ulcerative colitis at least 90 days prior randomisation.;2. Men or women age18 - 75 years. ;3. Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalisylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization;4. Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1. ;5. Nonsterilized males or sterilized males who are <= 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception.
Exclusion criteria
1. Pregnant or breastfeeding women. ;2. History of colostomy.;3. Current diagnosis of indeterminate colitis, Crohn*s disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis). ;4. Hepatitis B, C or HIV.;5. History of cancer.
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 | EUCTR2011-004812-40-NL |
| CCMO | NL38894.028.11 |