NCT01482884

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
6 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 5, 2016

Completed
Last Updated

April 5, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

November 29, 2011

Results QC Date

January 20, 2015

Last Update Submit

March 7, 2016

Conditions

Ulcerative Colitis

Keywords

tralokinumabinflammatory bowel diseasemoderate to severe ulcerative colitis

Outcome Measures

Primary Outcomes (1)

  • Clinical Response at Week 8 Based on Mayo Score

    Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.

    Eight week treatment period

Secondary Outcomes (10)

  • Change in Mayo Score From Baseline to Week 8

    Eight week treatment period

  • Mucosal Healing at Week 8 Based on Mayo Score

    Eight week treatment period

  • Clinical Remission at Week 8 Based on Mayo Score

    Eight week treatment period

  • Change From Baseline in Partial Mayo Score

    From baseline to Week 4, 8, 12, 16, 20, and 24.

  • Change From Baseline in Modified Riley Score

    Eight week treatment period

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

tralokinumab (CAT-354) sc injection

Drug: tralokinumab

2

PLACEBO COMPARATOR

placebo sc injection

Drug: placebo

Interventions

tralokinumabDRUG

2 sc injections of every 2 weeks for 12 weeks.

1
placeboDRUG

2 sc injections of every 2 weeks for 12 weeks.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Research Site

České Budějovice, Czechia

Location

Research Site

Hradec Králové, Czechia

Location

Research Site

Olomouc, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Amiens, France

Location

Research Site

Caen, France

Location

Research Site

Clichy, France

Location

Research Site

Nice, France

Location

Research Site

Pessac, France

Location

Research Site

Rouen, France

Location

Research Site

Vandœuvre-lès-Nancy, France

Location

Research Site

Ludwigshafen, Germany

Location

Research Site

Oelde, Germany

Location

Research Site

Potsdam, Germany

Location

Research Site

Wangen, Germany

Location

Research Site

Florence, Italy

Location

Research Site

Padua, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Rozzano, Italy

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Częstochowa, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Sopot, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Cambridge, United Kingdom

Location

Research Site

Coventry, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

Research Site

Shrewsbury, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25304132RESULT

Related Links

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Mark Berner Hansen
Organization
AstraZeneca
Mark.Berner.Hansen@astrazeneca.com
+46 31 776 4794

Study Officials

  • Mark Berner Hansen, MD, PhD

    AstraZeneca R&D Mölndal Pepparedsleden 1, S-431 83 Mölndal, Sweden

    STUDY DIRECTOR

  • Silvio Danese, MD, PhD

    IBD Center, Instituto Clinico Humanitas, Department of Gastroenterology, Via Manzoni 56, 20089 Rozzano, Milan, Italy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

April 5, 2016

Results First Posted

April 5, 2016

Record last verified: 2016-03

Locations

IT(4)CZ(4)DE(4)GB(4)PL(5)FR(7)