The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis (CONDUCT)

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ClinicalTrials.gov Identifier: NCT03178669

Recruitment Status : Completed

First Posted : June 7, 2017

Results First Posted : February 1, 2021

Last Update Posted : February 1, 2021

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	Ulcerative Colitis
Interventions	Drug: cobitolimod Drug: Placebo
Enrollment	213

Participant Flow

Recruitment Details
Pre-assignment Details	1 patient in the 2x31 mg and one patient in the 4x125 mg was never treated with study drug and excluded from analysis.


Arm/Group Title	Cobitolimod Dose 2x31 mg	Cobitolimod Dose 2x125 mg	Cobitolimod Dose 2x250 mg	Cobitolimod Dose 4x125 mg	Placebo
Arm/Group Description	Dose 31 mg of cobitolimod at 2 occa...	Dose 125 mg of cobitolimod at 2 occ...	Dose 250 mg of cobitolimod at 2 occ...	Dose 125 mg of cobitolimod, at 4 oc...	Placebo at four occasions ...
Arm/Group Description	Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration	Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod
Period Title: Overall Study
Started	40	43	42	42	44
Completed Week 6 ^[1]	35	42	36	38	42
Completed ^[2]	35	42	35	38	40
Not Completed	5	1	7	4	4
Reason Not Completed
Adverse Event	4	1	4	2	2
Lack of Efficacy	0	0	2	0	1
Physician Decision	0	0	0	0	1
Withdrawal by Subject	1	0	1	1	0
Lost to Follow-up	0	0	0	1	0
[1] Completed Week 6 [2] Completed Week 10

Baseline Characteristics

Arm/Group Title		Cobitolimod Dose 2x31 mg	Cobitolimod Dose 2x125 mg	Cobitolimod Dose 2x250 mg	Cobitolimod Dose 4x125 mg	Placebo	Total
Arm/Group Description		Dose 31 mg of cobitolimod at 2 occa...	Dose 125 mg of cobitolimod at 2 occ...	Dose 250 mg of cobitolimod at 2 occ...	Dose 125 mg of cobitolimod, at 4 oc...	Placebo at four occasions ...	Total of all reporting groups
Arm/Group Description		Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration	Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod	Total of all reporting groups
Overall Number of Baseline Participants		40	43	42	42	44	211
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		47.4 (16.4)	47.0 (16.9)	46.2 (14.0)	47.2 (14.9)	45.5 (15.2)	46.6 (15.4)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
	Female	14 35.0%	23 53.5%	16 38.1%	18 42.9%	11 25.0%	82 38.9%
	Male	26 65.0%	20 46.5%	26 61.9%	24 57.1%	33 75.0%	129 61.1%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
Ethnicity : Asian	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Ethnicity : Asian		0 0.0%	1 2.3%	1 2.4%	2 4.8%	2 4.5%	6 2.8%
Ethnicity : White	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Ethnicity : White		39 97.5%	42 97.7%	40 95.2%	39 92.9%	42 95.5%	202 95.7%
Ethnicity : Other	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Ethnicity : Other		1 2.5%	0 0.0%	1 2.4%	1 2.4%	0 0.0%	3 1.4%
Body weight Mean (Standard Deviation) Unit of measure: Kg
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		75.5 (16.70)	71.5 (14.85)	73.3 (13.15)	73.1 (17.53)	78.1 (12.89)	74.3 (15.14)
Body Mass Index (BMI) Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		25.1 (4.54)	24.7 (4.65)	24.5 (3.70)	24.7 (5.06)	25.9 (4.80)	25.0 (4.56)
Tobacco use at screening Measure Type: Count of Participants Unit of measure: Participants
Never smoked	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Never smoked		30 75.0%	28 65.1%	30 71.4%	30 71.4%	31 70.5%	149 70.6%
Current smoker	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Current smoker		1 2.5%	2 4.7%	2 4.8%	1 2.4%	2 4.5%	8 3.8%
Former smoker	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Former smoker		9 22.5%	13 30.2%	10 23.8%	11 26.2%	11 25.0%	54 25.6%
Total inflammatory Bowel Disease Questionnaire score (IBDQ) ^[1] Mean (Standard Deviation) Unit of measure: Scores on a scale
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		131.9 (28.11)	140.1 (32.46)	131.5 (36.64)	120.9 (34.81)	133.9 (28.58)	131.7 (32.59)
		[1] Measure Description: The IBDQ is an instrument used to assess quality of life in participants. It includes 32 questions on 4 domains : Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse health.
Duration of Ulcerative Colitis (UC) Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		7.88 (6.480)	8.46 (7.431)	7.89 (6.830)	8.14 (6.772)	7.36 (7.277)	7.94 (6.920)
Stool frequency per day Mean (Standard Deviation) Unit of measure: Stools per day
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		6.3 (2.93)	5.0 (1.83)	5.7 (2.73)	5.7 (2.56)	5.9 (3.04)	5.7 (2.62)
Mayo score ^[1] Mean (Standard Deviation) Unit of measure: Scores on a scale
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		8.5 (1.2)	8.0 (1.8)	8.5 (1.3)	8.3 (1.7)	8.3 (1.6)	8.3 (1.5)
		[1] Measure Description: The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings (excluding friability at grade 1), and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. Higher values represent worse disease.
Mayo stool frequency subscore ^[1] Measure Type: Count of Participants Unit of measure: Participants
0	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
0		2 5.0%	8 18.6%	3 7.1%	2 4.8%	4 9.1%	19 9.0%
1	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
1		7 17.5%	11 25.6%	8 19.0%	8 19.0%	10 22.7%	44 20.9%
2	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
2		17 42.5%	10 23.3%	17 40.5%	16 38.1%	10 22.7%	70 33.2%
3	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
3		14 35.0%	14 32.6%	14 33.3%	16 38.1%	20 45.5%	78 37.0%
		[1] Measure Description: Mayo stool frequency subscore: 0=normal, 1=one to two stools per day more than normal, 2=three to four stools per day more than normal, 3=more than four stools per day more than normal.
Mayo rectal bleeding subscore ^[1] Measure Type: Count of Participants Unit of measure: Participants
0	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
0		0 0.0%	4 9.3%	0 0.0%	1 2.4%	4 9.1%	9 4.3%
1	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
1		11 27.5%	9 20.9%	16 38.1%	17 40.5%	15 34.1%	68 32.2%
2	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
2		27 67.5%	26 60.5%	21 50.0%	21 50.0%	22 50.0%	117 55.5%
3	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
3		2 5.0%	4 9.3%	5 11.9%	3 7.1%	3 6.8%	17 8.1%
		[1] Measure Description: Mayo rectal bleeding sub-score: 0=none, 1=visible blood with stool less than half the time, 2=visible blood with stool half the time or more, 3=passing blood alone.
Mayo endoscopic subscore ^[1] Measure Type: Count of Participants Unit of measure: Participants
2	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
2		18 45.0%	17 39.5%	17 40.5%	19 45.2%	20 45.5%	91 43.1%
3	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
3		22 55.0%	26 60.5%	25 59.5%	23 54.8%	24 54.5%	120 56.9%
		[1] Measure Description: Mayo endoscopic subscore: 2=moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration).
Mayo Physicians Global Assessment (PGA) subscore ^[1] Measure Type: Count of Participants Unit of measure: Participants
1	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
1		2 5.0%	4 9.3%	3 7.1%	4 9.5%	3 6.8%	16 7.6%
2	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
2		32 80.0%	34 79.1%	32 76.2%	31 73.8%	31 70.5%	160 75.8%
3	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
3		6 15.0%	5 11.6%	7 16.7%	7 16.7%	10 22.7%	35 16.6%
		[1] Measure Description: Mayo PGA subscore:1=mild disease, 2=moderate disease, 3=severe disease.
Disease extent Measure Type: Count of Participants Unit of measure: Participants
Rectosigmoid	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Rectosigmoid		23 57.5%	22 51.2%	19 45.2%	23 54.8%	21 47.7%	108 51.2%
Descending colon	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Descending colon		17 42.5%	21 48.8%	23 54.8%	19 45.2%	23 52.3%	103 48.8%
Nancy Histological Index (NHI) score ^[1] [2] Measure Type: Count of Participants Unit of measure: Participants
0	Number Analyzed	40 participants	43 participants	40 participants	42 participants	44 participants	209 participants
0		0 0.0%	0 0.0%	2 5.0%	0 0.0%	1 2.3%	3 1.4%
1	Number Analyzed	40 participants	43 participants	40 participants	42 participants	44 participants	209 participants
1		0 0.0%	2 4.7%	0 0.0%	1 2.4%	2 4.5%	5 2.4%
2	Number Analyzed	40 participants	43 participants	40 participants	42 participants	44 participants	209 participants
2		4 10.0%	4 9.3%	3 7.5%	6 14.3%	3 6.8%	20 9.6%
3	Number Analyzed	40 participants	43 participants	40 participants	42 participants	44 participants	209 participants
3		14 35.0%	18 41.9%	17 42.5%	14 33.3%	13 29.5%	76 36.4%
4	Number Analyzed	40 participants	43 participants	40 participants	42 participants	44 participants	209 participants
4		22 55.0%	19 44.2%	18 45.0%	21 50.0%	25 56.8%	105 50.2%
		[1] Measure Description: Nancy Histological Index (NHI) classifies histologic status, a score from 0 to 4. Grade 0= no histological findings, grade 1= no acute acute inflammatory infiltrate, grade 2= acute inflammatory cells infiltrate and no ulceration 3= acute inflammatory cells infiltrate and no ulceration 4= ulceration. The most severe observation across all segments is used for the final NHI score. A higher score indicates more severe disease. [2] Measure Analysis Population Description: Missing NHI score for 2 patients
Faecal calprotectin Mean (Standard Deviation) Unit of measure: Mg/kg
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		3563 (6256)	3389 (5669)	2654 (4294)	3730 (4954)	3263 (5379)	3313 (5292)
C-reactive protein (CRP) Mean (Standard Deviation) Unit of measure: mg/L
	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
		7.6 (16.2)	4.9 (5.0)	7.1 (9.5)	9.7 (16.9)	8.1 (12.1)	7.5 (11.9)
Concomitant Ulcerative Colitis(UC) medication Measure Type: Count of Participants Unit of measure: Participants
5-aminosalicylic acid (5-ASA)	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
5-aminosalicylic acid (5-ASA)		35 87.5%	38 88.4%	33 78.6%	33 78.6%	39 88.6%	178 84.4%
Corticosteroids	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Corticosteroids		18 45.0%	13 30.2%	17 40.5%	14 33.3%	17 38.6%	79 37.4%
Thiopurines	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Thiopurines		9 22.5%	6 14.0%	9 21.4%	10 23.8%	7 15.9%	41 19.4%
Previous UC therapy Measure Type: Count of Participants Unit of measure: Participants
Thiopurines	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Thiopurines		39 97.5%	40 93.0%	42 100.0%	40 95.2%	42 95.5%	203 96.2%
Anti-TNF Therapy	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Anti-TNF Therapy		9 22.5%	10 23.3%	9 21.4%	12 28.6%	8 18.2%	48 22.7%
Vedolizumab	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Vedolizumab		4 10.0%	3 7.0%	5 11.9%	3 7.1%	0 0.0%	15 7.1%
Tofacitinib	Number Analyzed	40 participants	43 participants	42 participants	42 participants	44 participants	211 participants
Tofacitinib		1 2.5%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 0.5%

Outcome Measures

1.Primary Outcome


Title	Clinical Remission
Description	Patients with clinical remission at Week 6 (yes=1, no=0), defined by M...
Description	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).
Time Frame	6 weeks after first treatment

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Cobitolimod Dose 2x31 mg	Cobitolimod Dose 2x125 mg	Cobitolimod Dose 2x250 mg	Cobitolimod Dose 4x125 mg	Placebo
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occa...	Dose 125 mg of cobitolimod at 2 occ...	Dose 250 mg of cobitolimod at 2 occ...	Dose 125 mg of cobitolimod, at 4 oc...	Placebo at four occasions ...
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration	Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod
Overall Number of Participants Analyzed	40	43	42	42	44
Measure Type: Count of Participants Unit of Measure: Participants
	5 12.5%	2 4.7%	9 21.4%	4 9.5%	3 6.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x31 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1806
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.0
	Confidence Interval	(2-Sided) 80% 0.75 to 5.47
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6649
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 80% 0.20 to 2.24
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x250 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0247
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.8
	Confidence Interval	(2-Sided) 80% 1.53 to 9.47
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 4x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3279
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 80% 0.52 to 3.88
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Modified Clinical Remission
Description	Patients with modified clinical remission at Week 6 (yes=1, no=0), def...
Description	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
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Cobitolimod Dose 2x31 mg	Cobitolimod Dose 2x125 mg	Cobitolimod Dose 2x250 mg	Cobitolimod Dose 4x125 mg	Placebo
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occa...	Dose 125 mg of cobitolimod at 2 occ...	Dose 250 mg of cobitolimod at 2 occ...	Dose 125 mg of cobitolimod, at 4 oc...	Placebo at four occasions ...
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration	Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod
Overall Number of Participants Analyzed	33	41	35	39	39
Measure Type: Count of Participants Unit of Measure: Participants
	5 15.2%	1 2.4%	7 20.0%	3 7.7%	3 7.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x31 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2115
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 80% 0.69 to 4.99
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8498
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 80% 0.06 to 1.34
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x250 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0977
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 80% 1.01 to 6.62
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 4x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5220
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 80% 0.32 to 2.84
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Symptomatic Remission
Description	Patients with symptomatic remission at Week 6 (yes=1, no=0), defined b...
Description	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)
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Cobitolimod Dose 2x31 mg	Cobitolimod Dose 2x125 mg	Cobitolimod Dose 2x250 mg	Cobitolimod Dose 4x125 mg	Placebo
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occa...	Dose 125 mg of cobitolimod at 2 occ...	Dose 250 mg of cobitolimod at 2 occ...	Dose 125 mg of cobitolimod, at 4 oc...	Placebo at four occasions ...
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration	Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod
Overall Number of Participants Analyzed	37	42	37	40	43
Measure Type: Count of Participants Unit of Measure: Participants
	10 27.0%	11 26.2%	13 35.1%	10 25.0%	9 20.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x31 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2335
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 80% 0.74 to 2.94
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2511
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 80% 0.73 to 2.69
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x250 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1162
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 80% 0.96 to 3.52
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 4x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3467
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 80% 0.63 to 2.40
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Clinical Response
Description	Patients with clinical response at Week 6 (yes=1, no=0), defined as cl...
Description	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)
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Cobitolimod Dose 2x31 mg	Cobitolimod Dose 2x125 mg	Cobitolimod Dose 2x250 mg	Cobitolimod Dose 4x125 mg	Placebo
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occa...	Dose 125 mg of cobitolimod at 2 occ...	Dose 250 mg of cobitolimod at 2 occ...	Dose 125 mg of cobitolimod, at 4 oc...	Placebo at four occasions ...
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration	Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod
Overall Number of Participants Analyzed	33	41	35	39	39
Measure Type: Count of Participants Unit of Measure: Participants
	17 51.5%	18 43.9%	20 57.1%	15 38.5%	20 51.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x31 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6326
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 80% 0.50 to 1.50
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7127
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 80% 0.45 to 1.37
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x250 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2658
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 80% 0.75 to 2.34
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 4x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8301
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 80% 0.36 to 1.16
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Endoscopic Remission
Description	Patients with endoscopic remission at Week 6 (yes=1, no=0), defined by...
Description	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)
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Cobitolimod Dose 2x31 mg	Cobitolimod Dose 2x125 mg	Cobitolimod Dose 2x250 mg	Cobitolimod Dose 4x125 mg	Placebo
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occa...	Dose 125 mg of cobitolimod at 2 occ...	Dose 250 mg of cobitolimod at 2 occ...	Dose 125 mg of cobitolimod, at 4 oc...	Placebo at four occasions ...
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration	Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod
Overall Number of Participants Analyzed	34	41	37	39	40
Measure Type: Count of Participants Unit of Measure: Participants
	7 20.6%	5 12.2%	15 40.5%	10 25.6%	12 30.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x31 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7994
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 80% 0.32 to 1.27
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9665
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 80% 0.16 to 0.72
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x250 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2049
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 80% 0.80 to 2.82
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 4x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6504
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 80% 0.42 to 1.60
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Histological Remission
Description	Patients with histological remission at Week 6 (yes=1, no=0), defined ...
Description	Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Cobitolimod Dose 2x31 mg	Cobitolimod Dose 2x125 mg	Cobitolimod Dose 2x250 mg	Cobitolimod Dose 4x125 mg	Placebo
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occa...	Dose 125 mg of cobitolimod at 2 occ...	Dose 250 mg of cobitolimod at 2 occ...	Dose 125 mg of cobitolimod, at 4 oc...	Placebo at four occasions ...
Arm/Group Description:	Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration	Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration	Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod
Overall Number of Participants Analyzed	35	41	37	39	41
Measure Type: Count of Participants Unit of Measure: Participants
	4 11.4%	5 12.2%	8 21.6%	7 17.9%	10 24.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x31 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9207
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 80% 0.18 to 0.93
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9228
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 80% 0.19 to 0.92
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 2x250 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6636
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 80% 0.39 to 1.61
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cobitolimod Dose 4x125 mg, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7449
	Comments	one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 80% 0.34 to 1.41
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	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)
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Cobitolimod Dose 2x31 mg		Cobitolimod Dose 2x125 mg		Cobitolimod Dose 2x250 mg		Cobitolimod Dose 4x125 mg		Placebo
Arm/Group Description	Dose 31 mg of cobitolimod at 2 occa...		Dose 125 mg of cobitolimod at 2 occ...		Dose 250 mg of cobitolimod at 2 occ...		Dose 125 mg of cobitolimod, at 4 oc...		Placebo at four occasions ...
Arm/Group Description	Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration		Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration		Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration		Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration		Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod
All-Cause Mortality
	Cobitolimod Dose 2x31 mg		Cobitolimod Dose 2x125 mg		Cobitolimod Dose 2x250 mg		Cobitolimod Dose 4x125 mg		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/40 (0.00%)		0/43 (0.00%)		0/42 (0.00%)		0/42 (0.00%)		1/44 (2.27%)
Serious Adverse Events Serious Adverse Events
	Cobitolimod Dose 2x31 mg		Cobitolimod Dose 2x125 mg		Cobitolimod Dose 2x250 mg		Cobitolimod Dose 4x125 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/40 (5.00%)		0/43 (0.00%)		4/42 (9.52%)		2/42 (4.76%)		2/44 (4.55%)
Gastrointestinal disorders
Ulcerative colitis ^* 1	2/40 (5.00%)	2	0/43 (0.00%)	0	3/42 (7.14%)	3	1/42 (2.38%)	1	2/44 (4.55%)	2
Abdominal hernia ^* 1	0/40 (0.00%)	0	0/43 (0.00%)	0	1/42 (2.38%)	1	0/42 (0.00%)	0	0/44 (0.00%)	0
Injury, poisoning and procedural complications
Wound Dehiscence ^* 1	0/40 (0.00%)	0	0/43 (0.00%)	0	1/42 (2.38%)	1	0/42 (0.00%)	0	0/44 (0.00%)	0
Skin and subcutaneous tissue disorders
Pruritus ^* 1	0/40 (0.00%)	0	0/43 (0.00%)	0	0/42 (0.00%)	0	1/42 (2.38%)	1	0/44 (0.00%)	0
Rash erythematous ^* 1	0/40 (0.00%)	0	0/43 (0.00%)	0	0/42 (0.00%)	0	1/42 (2.38%)	1	0/44 (0.00%)	0
Vascular disorders
Deep vein thrombosis ^* 1	0/40 (0.00%)	0	0/43 (0.00%)	0	1/42 (2.38%)	1	0/42 (0.00%)	0	0/44 (0.00%)	0
1 Term from vocabulary, MedDRA (20.0) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cobitolimod Dose 2x31 mg		Cobitolimod Dose 2x125 mg		Cobitolimod Dose 2x250 mg		Cobitolimod Dose 4x125 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/40 (12.50%)		12/43 (27.91%)		8/42 (19.05%)		10/42 (23.81%)		11/44 (25.00%)
Gastrointestinal disorders
Ulcerative colitis ^* 1	2/40 (5.00%)	3	5/43 (11.63%)	5	4/42 (9.52%)	5	2/42 (4.76%)	3	3/44 (6.82%)	4
General disorders
Pyrexia ^* 1	1/40 (2.50%)	1	1/43 (2.33%)	1	0/42 (0.00%)	0	2/42 (4.76%)	2	3/44 (6.82%)	4
Infections and infestations
Viral upper respiratory infection ^* 1	0/40 (0.00%)	0	1/43 (2.33%)	1	2/42 (4.76%)	2	2/42 (4.76%)	2	4/44 (9.09%)	4
Investigations
Faecal calprotectin increased ^* 1	2/40 (5.00%)	2	0/43 (0.00%)	0	0/42 (0.00%)		2/42 (4.76%)	2	1/44 (2.27%)	1
Nervous system disorders
Headache ^* 1	0/40 (0.00%)	0	5/43 (11.63%)	5	2/42 (4.76%)	2	2/42 (4.76%)	4	0/44 (0.00%)	0
1 Term from vocabulary, MedDRA (20.0) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Karin Arnesson, Clinical Trial Manager
Organization:	InDex Pharmaceuticals
Phone:	+46 8 122 038 57
EMail:	karin.arnesson@indexpharma.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hébuterne X, Arnesson K, Knittel T, Kowalski J, Neurath MF, Sandborn WJ, Reinisch W; CONDUCT study group. Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial. Lancet Gastroenterol Hepatol. 2020 Dec;5(12):1063-1075. doi: 10.1016/S2468-1253(20)30301-0. Epub 2020 Oct 5.

Layout table for additonal information

Responsible Party:	InDex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT03178669
Other Study ID Numbers:	CSUC-01/16 2016-004217-26 ( EudraCT Number )
First Submitted:	June 5, 2017
First Posted:	June 7, 2017
Results First Submitted:	November 13, 2020
Results First Posted:	February 1, 2021
Last Update Posted:	February 1, 2021

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