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Trial record 8 of 10 for:    CAT-354

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

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ClinicalTrials.gov Identifier: NCT01482884
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Collaborator:
MedImmune Ltd
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Interventions: Drug: tralokinumab
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
147/111 patients were enrolled/randomized from 31 centres in 6 European countries. The first patient was enrolled on 26 March 2012, and the last patient completed the study on 24 June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled for a period of 3 weeks.

Reporting Groups
  Description
Tralokinumab Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.

Participant Flow:   Overall Study
    Tralokinumab   Placebo
STARTED   56 [1]   55 
COMPLETED   43   37 
NOT COMPLETED   13   18 
Medical decision due to lack of efficacy                0                1 
Protocol Violation                1                0 
Lost to Follow-up                2                2 
Lack of Efficacy                0                1 
Adverse Event                2                1 
Withdrawal by Subject                8                13 
[1] One participant did not receive study treatment



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomised participants.

Reporting Groups
  Description
Tralokinumab Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Total Total of all reporting groups

Baseline Measures
   Tralokinumab   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   55   111 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.2  (11.54)   40.8  (13.26)   41.5  (12.39) 
Gender 
[Units: Participants]
     
Female   29   29   58 
Male   27   26   53 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   2   0   2 
White   54   54   108 
Other   0   1   1 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   2   2   4 
Asian (Other than Chinese And Japanese)   2   0   2 
Not Applicable   35   40   75 
Other   17   13   30 
Duration of disease 
[Units: Years]
Mean (Standard Deviation)
 9.22  (8.523)   7.78  (8.664)   8.51  (8.585) 
Mayo score at baseline [1] 
[Units: Scores on scale]
Mean (Full Range)
 8.36 
 (5.0 to 11.0) 
 8.33 
 (6.0 to 11.0) 
 8.34 
 (5.0 to 11.0) 
[1] Mayo score is the 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.
Partial Mayo score at baseline [1] 
[Units: Scores on scale]
Mean (Full Range)
 5.91 
 (3.0 to 8.0) 
 5.85 
 (3.0 to 8.0) 
 5.88 
 (3.0 to 8.0) 
[1] The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician’s global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease.
Glucocorticosteroid-refractory status [1] 
[Units: Participants]
     
Yes   3   8   11 
No   53   46   99 
Unknown   0   1   1 
[1] Yes: if participants had received a glucocorticosteroid treatment prior to baseline and the outcome of that treatment was no improvement. No: If the outcome of the treatment was improvement or missing. Unknown: If the outcome of the treatment was unknown.


  Outcome Measures

1.  Primary:   Clinical Response at Week 8 Based on Mayo Score   [ Time Frame: Eight week treatment period ]

2.  Secondary:   Change in Mayo Score From Baseline to Week 8   [ Time Frame: Eight week treatment period ]

3.  Secondary:   Mucosal Healing at Week 8 Based on Mayo Score   [ Time Frame: Eight week treatment period ]

4.  Secondary:   Clinical Remission at Week 8 Based on Mayo Score   [ Time Frame: Eight week treatment period ]

5.  Secondary:   Change From Baseline in Partial Mayo Score   [ Time Frame: From baseline to Week 4, 8, 12, 16, 20, and 24. ]

6.  Secondary:   Change From Baseline in Modified Riley Score   [ Time Frame: Eight week treatment period ]

7.  Secondary:   Change From Baseline in C - Reactive Protein   [ Time Frame: From baseline to Week 4, 8, 12, 16, 20, and 24. ]

8.  Secondary:   Change From Baseline in Albumin   [ Time Frame: From baseline to Week 4, 8, 12, 16, 20, and 24. ]

9.  Secondary:   Change From Baseline in Calprotectin   [ Time Frame: From baseline to Week 4, 8, 12, 16, 20, and 24. ]

10.  Secondary:   Serum Concentration of Tralokinumab   [ Time Frame: Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24. ]

11.  Secondary:   Immunogenicity   [ Time Frame: Pre-dose sampling at baseline, Week 8, 12, 16, and 24. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Berner Hansen
Organization: AstraZeneca
phone: +46 31 776 4794
e-mail: Mark.Berner.Hansen@astrazeneca.com


Publications of Results:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01482884     History of Changes
Other Study ID Numbers: D2211C00001
EudraCT number 2011-004812-40
First Submitted: November 29, 2011
First Posted: December 1, 2011
Results First Submitted: January 20, 2015
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016