Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482884
• Other study ID #: D2211C00001
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2011
• Last updated: January 12, 2015
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• tralokinumab
2 sc injections of every 2 weeks for 12 weeks.
• placebo
2 sc injections of every 2 weeks for 12 weeks.

Locations

Country	Name	City	State
Czech Republic	Research Site	Ceske Budejovice
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Praha 1
Czech Republic	Research Site	Praha 5
Czech Republic	Research Site	Praha 7
France	Research Site	Amiens Cedex 1
France	Research Site	Caen
France	Research Site	Clichy
France	Research Site	Nice Cedex 3
France	Research Site	Pessac
France	Research Site	Rouen
France	Research Site	Vandoeuvre Les Nancy
Germany	Research Site	Ludwigshafen
Germany	Research Site	Oelde
Germany	Research Site	Potsdam
Germany	Research Site	Wangen
Italy	Research Site	Firenze
Italy	Research Site	Padova
Italy	Research Site	Roma
Italy	Research Site	Rozzano
Poland	Research Site	Bydgoszcz
Poland	Research Site	Czestochowa
Poland	Research Site	Lódz
Poland	Research Site	Sopot
Poland	Research Site	Warszawa
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Shrewsbury

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	MedImmune Ltd

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Italy,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		At week 8.	No
Secondary	Change in Mayo score (calculated as the sum of the four sub-scores: stool frequency rectal bleeding, endoscopy findings and the physician's overall assessment of the same in addition to abdominal discomfort and patient's general sense of well-being).		From baseline to week 8.	No
Secondary	Mucosal healing (defined as an improvement of the endoscopy sub-score (from the Mayo score) at week 8 from 3 or 2 to =1 point, or from 1 to 0 points).		At week 8.	No
Secondary	Change in partial Mayo score (calculated as the sum of the scoring from the three sub-score areas: stool frequency, rectal bleeding and the physician's global assessment).		From baseline to week 4, 8, 12, 16, 20, and 24.	No
Secondary	Clinical remission (defined as Mayo score of 2 or lower with no individual sub-score exceeding 1 point).		After 8 weeks.	No
Secondary	Histologic disease activity (assessment based on the modified Riley score).		At baseline and week 8.	No
Secondary	Markers of disease activity (CRP, calprotectin) and intestinal leakiness (albumin).		At baseline, week 4, 8, 12, 16, 20, and 24.	No
Secondary	Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in serum.		Pre-dose sampling at baseline, week 8, 12, 16, and 24.	No
Secondary	Tralokinumab serum concentration.		Pre-dose sampling at baseline, week 4, 8, 12, 16, 20, and 24.	No
Secondary	Safety and tolerability of tralokinumab in terms of adverse events, safety laboratory values, electrocardiograms, vital signs, weight, and physical examination findings.		From baseline to week 24	Yes