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The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients (COLLECT)

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ClinicalTrials.gov Identifier: NCT01493960
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
InDex Pharmaceuticals

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Colitis, Ulcerative
Interventions: Drug: Cobitolimod
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
There were 162 subjects screened. Whereof 31 did not meet the criteria

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were131 patients randomly assigned in a 2:1 allocation to receive 2 rectal doses of cobitolimod at 30 mg, or placebo, respectively.

Reporting Groups
  Description
Cobitolimod

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

Placebo

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4


Participant Flow:   Overall Study
    Cobitolimod   Placebo
STARTED   87   44 
Received Study Drug   87   43 
COMPLETED   55   26 
NOT COMPLETED   32   18 
Adverse Event                0                1 
Lack of Efficacy                15                9 
Protocol Violation                3                0 
Withdrawal by Subject                10                4 
Non-specified                4                4 



  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.
FAS

Reporting Groups
  Description
Cobitolimod

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

Placebo

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Total Total of all reporting groups

Baseline Measures
   Cobitolimod   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 81   43   124 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      76  93.8%      40  93.0%      116  93.5% 
>=65 years      5   6.2%      3   7.0%      8   6.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.1  (13.88)   43.1  (12.31)   41.8  (13.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      33  40.7%      11  25.6%      44  35.5% 
Male      48  59.3%      32  74.4%      80  64.5% 
Region of Enrollment 
[Units: Participants]
     
Czech Republic   13   6   19 
Hungary   13   6   19 
Poland   25   14   39 
Italy   2   3   5 
United Kingdom   8   3   11 
Germany   20   11   31 
Summary of CAI score at baseline by treatment group [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 11.1  (2.2)   10.8  (2.1)   11.0  (2.1) 
[1] Clinical Activity Index (CAI) which consists of a 7 item scale CAi score is a summary score ranging from 0-29 The summary score indicates increasing values with worsening symptoms


  Outcome Measures

1.  Primary:   Induction of Clinical Remission   [ Time Frame: Week 12 ]

2.  Secondary:   The Time to Colectomy   [ Time Frame: Within 12 months ]

3.  Secondary:   The Rate of Colectomy   [ Time Frame: at 12 months ]

4.  Secondary:   Steroid Free Remission at 12 Months   [ Time Frame: at 12 months ]

5.  Secondary:   The Induction of Mucosal Healing   [ Time Frame: Week 4 and 12 ]

6.  Secondary:   The Induction of Symptomatic Remission   [ Time Frame: Week 4, 12 ]

7.  Secondary:   The Induction of Registration Remission   [ Time Frame: Week 4 and 12 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr Thomas Knittel
Organization: Index Pharmaceuticals
phone: 0046 8 508 847 31
e-mail: thomas.knittel@indexpharma.com



Responsible Party: InDex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01493960     History of Changes
Other Study ID Numbers: CSUC-01/10
2011-003130-14 ( EudraCT Number )
First Submitted: December 12, 2011
First Posted: December 16, 2011
Results First Submitted: September 30, 2016
Results First Posted: January 24, 2018
Last Update Posted: January 24, 2018