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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
Enrollment 131
Recruitment Details There were 162 subjects screened. Whereof 31 did not meet the criteria
Pre-assignment Details There were131 patients randomly assigned in a 2:1 allocation to receive 2 rectal doses of cobitolimod at 30 mg, or placebo, respectively.
Arm/Group Title Cobitolimod Placebo
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2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Period Title: Overall Study
Started 87 44
Received Study Drug 87 43
Completed 55 26
Not Completed 32 18
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             15             9
Protocol Violation             3             0
Withdrawal by Subject             10             4
Non-specified             4             4
Arm/Group Title Cobitolimod Placebo Total
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2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Total of all reporting groups
Overall Number of Baseline Participants 81 43 124
Hide Baseline Analysis Population Description
FAS
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 43 participants 124 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 43 participants 124 participants
41.1  (13.88) 43.1  (12.31) 41.8  (13.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 43 participants 124 participants
Female
33
  40.7%
11
  25.6%
44
  35.5%
Male
48
  59.3%
32
  74.4%
80
  64.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants 43 participants 124 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 81 participants 43 participants 124 participants
11.1  (2.2) 10.8  (2.1) 11.0  (2.1)
[1]
Measure Description: 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
1.Primary Outcome
Title Induction of Clinical Remission
Hide Description The induction of clinical remission at week 12, defined as a CAI score of ≤4.(Full Analysis Set)
Time Frame Week 12
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Hide Analysis Population Description
The FAS consited of all randomized patients who met the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and received at least 1 dose of study drug (active or placebo), and who had at least 1 post randomization eligible value of the primary efficacy endpoint
Arm/Group Title Cobitolimod Placebo
Hide Arm/Group Description:

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Overall Number of Participants Analyzed 81 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
44.4
(34.1 to 55.3)
46.5
(32.5 to 61.1)
2.Secondary Outcome
Title The Time to Colectomy
Hide Description Median time to colectomy after 1st dose.
Time Frame Within 12 months
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Hide Analysis Population Description
FAS
Arm/Group Title Cobitolimod Placebo
Hide Arm/Group Description:

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Overall Number of Participants Analyzed 81 43
Median (95% Confidence Interval)
Unit of Measure: Time
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median was not reached due to few events
3.Secondary Outcome
Title The Rate of Colectomy
Hide Description Percentage of participants undergoing colectomy at 12 months after 1st dose.
Time Frame at 12 months
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Hide Analysis Population Description
FAS
Arm/Group Title Cobitolimod Placebo
Hide Arm/Group Description:

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Overall Number of Participants Analyzed 81 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects
4.9
(1.9 to 12.0)
11.6
(5.1 to 24.5)
4.Secondary Outcome
Title Steroid Free Remission at 12 Months
Hide Description Percentage of participants with steroid free remission at 12 months after 1st dose.
Time Frame at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Cobitolimod Placebo
Hide Arm/Group Description:

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Overall Number of Participants Analyzed 81 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects
32.1
(22.9 to 42.9)
30.2
(18.6 to 45.1)
5.Secondary Outcome
Title The Induction of Mucosal Healing
Hide Description Percentage of participants with induction of mucosal healing, defined as an endoscopic score of 0 or 1, at week 4 and 12.
Time Frame Week 4 and 12
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Hide Analysis Population Description
FAS
Arm/Group Title Cobitolimod Placebo
Hide Arm/Group Description:

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Overall Number of Participants Analyzed 81 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects
Week 4
34.6
(25.1 to 45.4)
18.6
(9.7 to 32.6)
Week 12
42.0
(31.8 to 52.8)
41.9
(28.4 to 56.7)
6.Secondary Outcome
Title The Induction of Symptomatic Remission
Hide Description Percentage of participants with induction of symptomatic remission, defined as subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1, respectively, at week 4 and 12.
Time Frame Week 4, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Cobitolimod Placebo
Hide Arm/Group Description:

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Overall Number of Participants Analyzed 81 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects
Week 4
32.1
(22.9 to 42.9)
14.0
(6.6 to 27.3)
Week 12
43.2
(33.0 to 54.1)
32.6
(20.5 to 47.5)
7.Secondary Outcome
Title The Induction of Registration Remission
Hide Description Percentage of participants with induction of registration remission, defined as a CAI score of ≤4 and an endoscopic score of 0 or 1, at week 4 and 12.
Time Frame Week 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Cobitolimod Placebo
Hide Arm/Group Description:

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

Overall Number of Participants Analyzed 81 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects
Week 4
21.0
(13.5 to 31.1)
4.7
(1.3 to 15.5)
Week 12
30.9
(21.9 to 41.6)
30.2
(18.6 to 45.1)
Time Frame 1 year, 2 weeks
Adverse Event Reporting Description All patients who entered into the study and were treated with at least 1 dose of study drug are included in the safety analysis set.
 
Arm/Group Title Cobitolimod Placebo
Hide Arm/Group Description

2 doses 4 weeks apart

Cobitolimod: 30 mg rectal dose at week 0 and 4

2 doses 4 weeks apart

Placebo: Rectal dose at week 0 and 4

All-Cause Mortality
Cobitolimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cobitolimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/87 (11.49%)   8/43 (18.60%) 
Blood and lymphatic system disorders     
Anemia * 1  1/87 (1.15%)  0/43 (0.00%) 
Cardiac disorders     
Acute Coronary syndrome * 1  1/87 (1.15%)  0/43 (0.00%) 
Myocardial Ischemia * 1  0/87 (0.00%)  1/43 (2.33%) 
Eye disorders     
Glaucoma * 1  1/87 (1.15%)  0/43 (0.00%) 
Retinal Veon Thrombosis * 1  0/87 (0.00%)  1/43 (2.33%) 
Gastrointestinal disorders     
Intestinal obstruction * 1  0/87 (0.00%)  1/43 (2.33%) 
Perirectal abscess * 1  1/87 (1.15%)  0/43 (0.00%) 
Vomiting * 1  0/87 (0.00%)  1/43 (2.33%) 
Infections and infestations     
Herpes Zoster * 1  0/87 (0.00%)  1/43 (2.33%) 
Injury, poisoning and procedural complications     
Overdose * 1  2/87 (2.30%)  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  1/87 (1.15%)  0/43 (0.00%) 
Spinal compression fracture * 1  1/87 (1.15%)  0/43 (0.00%) 
Nervous system disorders     
Sensory Distrurbance * 1  0/87 (0.00%)  1/43 (2.33%) 
Movement disorder * 1  0/87 (0.00%)  1/43 (2.33%) 
Reproductive system and breast disorders     
Clostridial infection * 1  0/87 (0.00%)  1/43 (2.33%) 
Benign Dysplaisa * 1  1/87 (1.15%)  0/43 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia * 1  0/87 (0.00%)  1/43 (2.33%) 
Skin and subcutaneous tissue disorders     
Rash * 1  1/87 (1.15%)  0/43 (0.00%) 
Vascular disorders     
Epistaxis * 1  1/87 (1.15%)  0/43 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Cobitolimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   31/87 (35.63%)   6/43 (13.95%) 
Blood and lymphatic system disorders     
Anemia * 1  4/87 (4.60%)  1/43 (2.33%) 
Endocrine disorders     
Cushingoid * 1  4/87 (4.60%)  0/43 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  3/87 (3.45%)  0/43 (0.00%) 
Infections and infestations     
Nasopharyngitis * 1  5/87 (5.75%)  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  3/87 (3.45%)  1/43 (2.33%) 
Nervous system disorders     
Headache * 1  5/87 (5.75%)  2/43 (4.65%) 
Psychiatric disorders     
Depression * 1  3/87 (3.45%)  0/43 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  4/87 (4.60%)  1/43 (2.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 14.1
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
Layout table for Results Point of Contact information
Name/Title: Dr Thomas Knittel
Organization: Index Pharmaceuticals
Phone: 0046 8 508 847 31
EMail: thomas.knittel@indexpharma.com
Layout table for additonal information
Responsible Party: InDex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01493960    
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