Trial Outcomes & Findings for The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis (NCT NCT03178669)
NCT ID: NCT03178669
Last Updated: 2021-02-01
Results Overview
Patients with clinical remission at Week 6 (yes=1, no=0), defined by Modified Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
213 participants
Primary outcome timeframe
6 weeks after first treatment
Results posted on
2021-02-01
Participant Flow
1 patient in the 2x31 mg and one patient in the 4x125 mg was never treated with study drug and excluded from analysis.
Participant milestones
| Measure |
Cobitolimod Dose 2x31 mg
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
43
|
42
|
42
|
44
|
|
Overall Study
Completed Week 6
|
35
|
42
|
36
|
38
|
42
|
|
Overall Study
COMPLETED
|
35
|
42
|
35
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
7
|
4
|
4
|
Reasons for withdrawal
| Measure |
Cobitolimod Dose 2x31 mg
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
4
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Missing NHI score for 2 patients
Baseline characteristics by cohort
| Measure |
Cobitolimod Dose 2x31 mg
n=40 Participants
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=43 Participants
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=42 Participants
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=42 Participants
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=44 Participants
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
|
47.4 years
STANDARD_DEVIATION 16.4 • n=40 Participants
|
47.0 years
STANDARD_DEVIATION 16.9 • n=43 Participants
|
46.2 years
STANDARD_DEVIATION 14.0 • n=42 Participants
|
47.2 years
STANDARD_DEVIATION 14.9 • n=42 Participants
|
45.5 years
STANDARD_DEVIATION 15.2 • n=44 Participants
|
46.6 years
STANDARD_DEVIATION 15.4 • n=211 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=40 Participants
|
23 Participants
n=43 Participants
|
16 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
11 Participants
n=44 Participants
|
82 Participants
n=211 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=40 Participants
|
20 Participants
n=43 Participants
|
26 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
33 Participants
n=44 Participants
|
129 Participants
n=211 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Asian
|
0 Participants
n=40 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=44 Participants
|
6 Participants
n=211 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : White
|
39 Participants
n=40 Participants
|
42 Participants
n=43 Participants
|
40 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
42 Participants
n=44 Participants
|
202 Participants
n=211 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Other
|
1 Participants
n=40 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=211 Participants
|
|
Body weight
|
75.5 kg
STANDARD_DEVIATION 16.70 • n=40 Participants
|
71.5 kg
STANDARD_DEVIATION 14.85 • n=43 Participants
|
73.3 kg
STANDARD_DEVIATION 13.15 • n=42 Participants
|
73.1 kg
STANDARD_DEVIATION 17.53 • n=42 Participants
|
78.1 kg
STANDARD_DEVIATION 12.89 • n=44 Participants
|
74.3 kg
STANDARD_DEVIATION 15.14 • n=211 Participants
|
|
Body Mass Index (BMI)
|
25.1 kg/m^2
STANDARD_DEVIATION 4.54 • n=40 Participants
|
24.7 kg/m^2
STANDARD_DEVIATION 4.65 • n=43 Participants
|
24.5 kg/m^2
STANDARD_DEVIATION 3.70 • n=42 Participants
|
24.7 kg/m^2
STANDARD_DEVIATION 5.06 • n=42 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 4.80 • n=44 Participants
|
25.0 kg/m^2
STANDARD_DEVIATION 4.56 • n=211 Participants
|
|
Tobacco use at screening
Never smoked
|
30 Participants
n=40 Participants
|
28 Participants
n=43 Participants
|
30 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
31 Participants
n=44 Participants
|
149 Participants
n=211 Participants
|
|
Tobacco use at screening
Current smoker
|
1 Participants
n=40 Participants
|
2 Participants
n=43 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=44 Participants
|
8 Participants
n=211 Participants
|
|
Tobacco use at screening
Former smoker
|
9 Participants
n=40 Participants
|
13 Participants
n=43 Participants
|
10 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=44 Participants
|
54 Participants
n=211 Participants
|
|
Total inflammatory Bowel Disease Questionnaire score (IBDQ)
|
131.9 scores on a scale
STANDARD_DEVIATION 28.11 • n=40 Participants
|
140.1 scores on a scale
STANDARD_DEVIATION 32.46 • n=43 Participants
|
131.5 scores on a scale
STANDARD_DEVIATION 36.64 • n=42 Participants
|
120.9 scores on a scale
STANDARD_DEVIATION 34.81 • n=42 Participants
|
133.9 scores on a scale
STANDARD_DEVIATION 28.58 • n=44 Participants
|
131.7 scores on a scale
STANDARD_DEVIATION 32.59 • n=211 Participants
|
|
Duration of Ulcerative Colitis (UC)
|
7.88 years
STANDARD_DEVIATION 6.480 • n=40 Participants
|
8.46 years
STANDARD_DEVIATION 7.431 • n=43 Participants
|
7.89 years
STANDARD_DEVIATION 6.830 • n=42 Participants
|
8.14 years
STANDARD_DEVIATION 6.772 • n=42 Participants
|
7.36 years
STANDARD_DEVIATION 7.277 • n=44 Participants
|
7.94 years
STANDARD_DEVIATION 6.920 • n=211 Participants
|
|
Stool frequency per day
|
6.3 Stools per day
STANDARD_DEVIATION 2.93 • n=40 Participants
|
5.0 Stools per day
STANDARD_DEVIATION 1.83 • n=43 Participants
|
5.7 Stools per day
STANDARD_DEVIATION 2.73 • n=42 Participants
|
5.7 Stools per day
STANDARD_DEVIATION 2.56 • n=42 Participants
|
5.9 Stools per day
STANDARD_DEVIATION 3.04 • n=44 Participants
|
5.7 Stools per day
STANDARD_DEVIATION 2.62 • n=211 Participants
|
|
Mayo score
|
8.5 scores on a scale
STANDARD_DEVIATION 1.2 • n=40 Participants
|
8.0 scores on a scale
STANDARD_DEVIATION 1.8 • n=43 Participants
|
8.5 scores on a scale
STANDARD_DEVIATION 1.3 • n=42 Participants
|
8.3 scores on a scale
STANDARD_DEVIATION 1.7 • n=42 Participants
|
8.3 scores on a scale
STANDARD_DEVIATION 1.6 • n=44 Participants
|
8.3 scores on a scale
STANDARD_DEVIATION 1.5 • n=211 Participants
|
|
Mayo stool frequency subscore
0
|
2 Participants
n=40 Participants
|
8 Participants
n=43 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=44 Participants
|
19 Participants
n=211 Participants
|
|
Mayo stool frequency subscore
1
|
7 Participants
n=40 Participants
|
11 Participants
n=43 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
10 Participants
n=44 Participants
|
44 Participants
n=211 Participants
|
|
Mayo stool frequency subscore
2
|
17 Participants
n=40 Participants
|
10 Participants
n=43 Participants
|
17 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
10 Participants
n=44 Participants
|
70 Participants
n=211 Participants
|
|
Mayo stool frequency subscore
3
|
14 Participants
n=40 Participants
|
14 Participants
n=43 Participants
|
14 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
20 Participants
n=44 Participants
|
78 Participants
n=211 Participants
|
|
Mayo rectal bleeding subscore
0
|
0 Participants
n=40 Participants
|
4 Participants
n=43 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=44 Participants
|
9 Participants
n=211 Participants
|
|
Mayo rectal bleeding subscore
1
|
11 Participants
n=40 Participants
|
9 Participants
n=43 Participants
|
16 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
15 Participants
n=44 Participants
|
68 Participants
n=211 Participants
|
|
Mayo rectal bleeding subscore
2
|
27 Participants
n=40 Participants
|
26 Participants
n=43 Participants
|
21 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
22 Participants
n=44 Participants
|
117 Participants
n=211 Participants
|
|
Mayo rectal bleeding subscore
3
|
2 Participants
n=40 Participants
|
4 Participants
n=43 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=44 Participants
|
17 Participants
n=211 Participants
|
|
Mayo endoscopic subscore
2
|
18 Participants
n=40 Participants
|
17 Participants
n=43 Participants
|
17 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
20 Participants
n=44 Participants
|
91 Participants
n=211 Participants
|
|
Mayo endoscopic subscore
3
|
22 Participants
n=40 Participants
|
26 Participants
n=43 Participants
|
25 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
24 Participants
n=44 Participants
|
120 Participants
n=211 Participants
|
|
Mayo Physicians Global Assessment (PGA) subscore
1
|
2 Participants
n=40 Participants
|
4 Participants
n=43 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=44 Participants
|
16 Participants
n=211 Participants
|
|
Mayo Physicians Global Assessment (PGA) subscore
2
|
32 Participants
n=40 Participants
|
34 Participants
n=43 Participants
|
32 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
31 Participants
n=44 Participants
|
160 Participants
n=211 Participants
|
|
Mayo Physicians Global Assessment (PGA) subscore
3
|
6 Participants
n=40 Participants
|
5 Participants
n=43 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
10 Participants
n=44 Participants
|
35 Participants
n=211 Participants
|
|
Disease extent
Rectosigmoid
|
23 Participants
n=40 Participants
|
22 Participants
n=43 Participants
|
19 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
21 Participants
n=44 Participants
|
108 Participants
n=211 Participants
|
|
Disease extent
Descending colon
|
17 Participants
n=40 Participants
|
21 Participants
n=43 Participants
|
23 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
23 Participants
n=44 Participants
|
103 Participants
n=211 Participants
|
|
Nancy Histological Index (NHI) score
0
|
0 Participants
n=40 Participants • Missing NHI score for 2 patients
|
0 Participants
n=43 Participants • Missing NHI score for 2 patients
|
2 Participants
n=40 Participants • Missing NHI score for 2 patients
|
0 Participants
n=42 Participants • Missing NHI score for 2 patients
|
1 Participants
n=44 Participants • Missing NHI score for 2 patients
|
3 Participants
n=209 Participants • Missing NHI score for 2 patients
|
|
Nancy Histological Index (NHI) score
1
|
0 Participants
n=40 Participants • Missing NHI score for 2 patients
|
2 Participants
n=43 Participants • Missing NHI score for 2 patients
|
0 Participants
n=40 Participants • Missing NHI score for 2 patients
|
1 Participants
n=42 Participants • Missing NHI score for 2 patients
|
2 Participants
n=44 Participants • Missing NHI score for 2 patients
|
5 Participants
n=209 Participants • Missing NHI score for 2 patients
|
|
Nancy Histological Index (NHI) score
2
|
4 Participants
n=40 Participants • Missing NHI score for 2 patients
|
4 Participants
n=43 Participants • Missing NHI score for 2 patients
|
3 Participants
n=40 Participants • Missing NHI score for 2 patients
|
6 Participants
n=42 Participants • Missing NHI score for 2 patients
|
3 Participants
n=44 Participants • Missing NHI score for 2 patients
|
20 Participants
n=209 Participants • Missing NHI score for 2 patients
|
|
Nancy Histological Index (NHI) score
3
|
14 Participants
n=40 Participants • Missing NHI score for 2 patients
|
18 Participants
n=43 Participants • Missing NHI score for 2 patients
|
17 Participants
n=40 Participants • Missing NHI score for 2 patients
|
14 Participants
n=42 Participants • Missing NHI score for 2 patients
|
13 Participants
n=44 Participants • Missing NHI score for 2 patients
|
76 Participants
n=209 Participants • Missing NHI score for 2 patients
|
|
Nancy Histological Index (NHI) score
4
|
22 Participants
n=40 Participants • Missing NHI score for 2 patients
|
19 Participants
n=43 Participants • Missing NHI score for 2 patients
|
18 Participants
n=40 Participants • Missing NHI score for 2 patients
|
21 Participants
n=42 Participants • Missing NHI score for 2 patients
|
25 Participants
n=44 Participants • Missing NHI score for 2 patients
|
105 Participants
n=209 Participants • Missing NHI score for 2 patients
|
|
Faecal calprotectin
|
3563 mg/kg
STANDARD_DEVIATION 6256 • n=40 Participants
|
3389 mg/kg
STANDARD_DEVIATION 5669 • n=43 Participants
|
2654 mg/kg
STANDARD_DEVIATION 4294 • n=42 Participants
|
3730 mg/kg
STANDARD_DEVIATION 4954 • n=42 Participants
|
3263 mg/kg
STANDARD_DEVIATION 5379 • n=44 Participants
|
3313 mg/kg
STANDARD_DEVIATION 5292 • n=211 Participants
|
|
C-reactive protein (CRP)
|
7.6 mg/L
STANDARD_DEVIATION 16.2 • n=40 Participants
|
4.9 mg/L
STANDARD_DEVIATION 5.0 • n=43 Participants
|
7.1 mg/L
STANDARD_DEVIATION 9.5 • n=42 Participants
|
9.7 mg/L
STANDARD_DEVIATION 16.9 • n=42 Participants
|
8.1 mg/L
STANDARD_DEVIATION 12.1 • n=44 Participants
|
7.5 mg/L
STANDARD_DEVIATION 11.9 • n=211 Participants
|
|
Concomitant Ulcerative Colitis(UC) medication
5-aminosalicylic acid (5-ASA)
|
35 Participants
n=40 Participants
|
38 Participants
n=43 Participants
|
33 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
39 Participants
n=44 Participants
|
178 Participants
n=211 Participants
|
|
Concomitant Ulcerative Colitis(UC) medication
Corticosteroids
|
18 Participants
n=40 Participants
|
13 Participants
n=43 Participants
|
17 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
17 Participants
n=44 Participants
|
79 Participants
n=211 Participants
|
|
Concomitant Ulcerative Colitis(UC) medication
Thiopurines
|
9 Participants
n=40 Participants
|
6 Participants
n=43 Participants
|
9 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
7 Participants
n=44 Participants
|
41 Participants
n=211 Participants
|
|
Previous UC therapy
Thiopurines
|
39 Participants
n=40 Participants
|
40 Participants
n=43 Participants
|
42 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
42 Participants
n=44 Participants
|
203 Participants
n=211 Participants
|
|
Previous UC therapy
Anti-TNF Therapy
|
9 Participants
n=40 Participants
|
10 Participants
n=43 Participants
|
9 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
8 Participants
n=44 Participants
|
48 Participants
n=211 Participants
|
|
Previous UC therapy
Vedolizumab
|
4 Participants
n=40 Participants
|
3 Participants
n=43 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=44 Participants
|
15 Participants
n=211 Participants
|
|
Previous UC therapy
Tofacitinib
|
1 Participants
n=40 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=211 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after first treatmentPopulation: The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Non Responder Imputation (NRI). Number of observed data is presented.
Patients with clinical remission at Week 6 (yes=1, no=0), defined by Modified Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).
Outcome measures
| Measure |
Cobitolimod Dose 2x31 mg
n=40 Participants
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=43 Participants
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=42 Participants
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=42 Participants
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=44 Participants
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Clinical Remission
|
5 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented in the table.
Patients with modified clinical remission at Week 6 (yes=1, no=0), defined by the Modified Mayo score ≤ 2 and sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), iii) endoscopy score of 0 or 1 (excluding friability ) and iiii) physician´s global assessment (PGA) of 0 or 1
Outcome measures
| Measure |
Cobitolimod Dose 2x31 mg
n=33 Participants
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=41 Participants
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=35 Participants
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=39 Participants
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=39 Participants
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Modified Clinical Remission
|
5 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented.
Patients with symptomatic remission at Week 6 (yes=1, no=0), defined by the Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), (patient reported outcome)
Outcome measures
| Measure |
Cobitolimod Dose 2x31 mg
n=37 Participants
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=42 Participants
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=37 Participants
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=40 Participants
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=43 Participants
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Symptomatic Remission
|
10 Participants
|
11 Participants
|
13 Participants
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented.
Patients with clinical response at Week 6 (yes=1, no=0), defined as clinical remission or a three point and ≥30 % decrease from Baseline, Week 0 in the sum of the Modified Mayo score, i) rectal bleeding, ii) stool frequency and iii) endoscopy score (excluding friability), iiii) physicians global assessment (PGA)
Outcome measures
| Measure |
Cobitolimod Dose 2x31 mg
n=33 Participants
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=41 Participants
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=35 Participants
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=39 Participants
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=39 Participants
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Clinical Response
|
17 Participants
|
18 Participants
|
20 Participants
|
15 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented.
Patients with endoscopic remission at Week 6 (yes=1, no=0), defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)
Outcome measures
| Measure |
Cobitolimod Dose 2x31 mg
n=34 Participants
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=41 Participants
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=37 Participants
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=39 Participants
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=40 Participants
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Endoscopic Remission
|
7 Participants
|
5 Participants
|
15 Participants
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented.
Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1
Outcome measures
| Measure |
Cobitolimod Dose 2x31 mg
n=35 Participants
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=41 Participants
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=37 Participants
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=39 Participants
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=41 Participants
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Histological Remission
|
4 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
Adverse Events
Cobitolimod Dose 2x31 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Cobitolimod Dose 2x125 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cobitolimod Dose 2x250 mg
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Cobitolimod Dose 4x125 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cobitolimod Dose 2x31 mg
n=40 participants at risk
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=43 participants at risk
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=42 participants at risk
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=42 participants at risk
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=44 participants at risk
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Ulcerative colitis
|
5.0%
2/40 • Number of events 2 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/43 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
7.1%
3/42 • Number of events 3 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.4%
1/42 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
4.5%
2/44 • Number of events 2 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/40 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/43 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.4%
1/42 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/42 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/44 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/40 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/43 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.4%
1/42 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/42 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/44 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/40 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/43 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/42 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.4%
1/42 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/44 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/40 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/43 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/42 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.4%
1/42 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/44 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/40 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/43 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.4%
1/42 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/42 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/44 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
Other adverse events
| Measure |
Cobitolimod Dose 2x31 mg
n=40 participants at risk
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x125 mg
n=43 participants at risk
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 2x250 mg
n=42 participants at risk
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration
|
Cobitolimod Dose 4x125 mg
n=42 participants at risk
Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration
|
Placebo
n=44 participants at risk
Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Ulcerative colitis
|
5.0%
2/40 • Number of events 3 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
11.6%
5/43 • Number of events 5 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
9.5%
4/42 • Number of events 5 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
4.8%
2/42 • Number of events 3 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
6.8%
3/44 • Number of events 4 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.3%
1/43 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/42 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
4.8%
2/42 • Number of events 2 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
6.8%
3/44 • Number of events 4 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
Infections and infestations
Viral upper respiratory infection
|
0.00%
0/40 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.3%
1/43 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
4.8%
2/42 • Number of events 2 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
4.8%
2/42 • Number of events 2 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
9.1%
4/44 • Number of events 4 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
11.6%
5/43 • Number of events 5 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
4.8%
2/42 • Number of events 2 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
4.8%
2/42 • Number of events 4 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/44 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
|
Investigations
Faecal calprotectin increased
|
5.0%
2/40 • Number of events 2 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/43 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
0.00%
0/42 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
4.8%
2/42 • Number of events 2 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
2.3%
1/44 • Number of events 1 • Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
|
Additional Information
Karin Arnesson, Clinical Trial Manager
InDex Pharmaceuticals
Phone: +46 8 122 038 57
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60