Clinical trial NCT01482884: Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
Official title: A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: tralokinumab
inflammatory bowel disease
moderate to severe ulcerative colitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: MedImmune Ltd
First posted: 2011-12-01
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.

Detailed description: A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Eligibility criteria: Inclusion Criteria:

* Diagnosed ulcerative colitis at least 90 days prior randomisation.
* Men or women age 18 - 75 years.
* Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization.
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1.
* 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:

* Pregnant or breastfeeding women.
* History of colostomy.
* 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).
* Hepatitis B, C or HIV.
* History of cancer.

Primary outcomes:
measure: Clinical Response at Week 8 Based on Mayo Score
timeFrame: Eight week treatment period
Secondary outcomes:
measure: Change in Mayo Score From Baseline to Week 8
timeFrame: Eight week treatment period
measure: Mucosal Healing at Week 8 Based on Mayo Score
timeFrame: Eight week treatment period
measure: Clinical Remission at Week 8 Based on Mayo Score
timeFrame: Eight week treatment period
measure: Change From Baseline in Partial Mayo Score
timeFrame: From baseline to Week 4, 8, 12, 16, 20, and 24.
measure: Change From Baseline in Modified Riley Score
timeFrame: Eight week treatment period
measure: Change From Baseline in C - Reactive Protein
timeFrame: From baseline to Week 4, 8, 12, 16, 20, and 24.
measure: Change From Baseline in Albumin
timeFrame: From baseline to Week 4, 8, 12, 16, 20, and 24.
measure: Change From Baseline in Calprotectin
timeFrame: From baseline to Week 4, 8, 12, 16, 20, and 24.
measure: Serum Concentration of Tralokinumab
timeFrame: Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.
measure: Immunogenicity
timeFrame: Pre-dose sampling at baseline, Week 8, 12, 16, and 24.
Other outcomes:
Locations:
city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Praha 1
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Praha 7
country: Czech Republic
facility: Research Site
city: Amiens Cedex 1
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Clichy
country: France
facility: Research Site
city: Nice Cedex 3
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Vandoeuvre Les Nancy
country: France
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Oelde
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Częstochowa
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Shrewsbury
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Mölndal Pepparedsleden 1, S-431 83 Mölndal, Sweden
name: Mark Berner Hansen, MD, PhD
role: STUDY_DIRECTOR
affiliation: IBD Center, Instituto Clinico Humanitas, Department of Gastroenterology, Via Manzoni 56, 20089 Rozzano, Milan, Italy
name: Silvio Danese, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danese S, Rudzinski J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.