Ulcerative Colitis
Conditions
Keywords
Colitis, Ulcerative, Gastrointestinal Diseases, Inflammatory Bowel Disease, Immunomodulator Therapy, Glucocorticoids, Anti-Inflammatory Agents, Therapeutic uses, Kappaproct, IDX0150, DIMS0150
Brief summary
The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.
Detailed description
This was a Phase IIb study in patients with moderate to severe left-sided ulcerative colitis. Patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. To ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. Blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. Primary endpoint was evaluated at week 6. Duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).
Interventions
DRUGcobitolimod
Rectal administration
DRUGPlacebo
Solution manufactured to mimic cobitolimod
Sponsors
InDex Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Established diagnosis of Ulcerative Colitis (UC) * Moderately to severely active left sided UC assessed by central reading * Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use * Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance * Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents: * Immunomodulators * Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins
Exclusion criteria
* Suspicion of differential diagnosis * Acute fulminant UC and/or signs of systemic toxicity * UC limited to the rectum (disease which extend \<15 cm above the anal verge) * History of malignancy * History or presence of any clinically significant disorder * Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators * Treatment with rectal GCS, 5-ASA/SP or tacrolimus * Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) * Serious active infection * Gastrointestinal infections * Currently receiving parenteral nutrition or blood transfusions * Females who are lactating or have a positive serum pregnancy test * Women of childbearing potential not using reliable contraceptive methods * Concurrent participation in another clinical study * Previous exposure to cobitolimod
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | 6 weeks after first treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Clinical Remission | Week 6 | 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 |
| Symptomatic Remission | Week 6 | 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) |
| Clinical Response | Week 6 | 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) |
| Endoscopic Remission | Week 6 | 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) |
| Histological Remission | Week 6 | Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1 |
Countries
Czechia, France, Germany, Hungary, Poland, Russia, Serbia, Spain, Sweden, Ukraine
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Cobitolimod Dose 2x31 mg Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration | 40 |
| Cobitolimod Dose 2x125 mg Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration | 43 |
| Cobitolimod Dose 2x250 mg Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
cobitolimod: Rectal administration | 42 |
| Cobitolimod Dose 4x125 mg Dose 125 mg of cobitolimod, at 4 occasions
cobitolimod: Rectal administration | 42 |
| Placebo Placebo at four occasions
Placebo: Solution manufactured to mimic cobitolimod | 44 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 | 4 | 2 | 2 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Cobitolimod Dose 2x125 mg | Cobitolimod Dose 2x250 mg | Cobitolimod Dose 4x125 mg | Placebo | Cobitolimod Dose 2x31 mg | Total |
|---|---|---|---|---|---|---|
| Age, Customized | 47.0 years STANDARD_DEVIATION 16.9 | 46.2 years STANDARD_DEVIATION 14 | 47.2 years STANDARD_DEVIATION 14.9 | 45.5 years STANDARD_DEVIATION 15.2 | 47.4 years STANDARD_DEVIATION 16.4 | 46.6 years STANDARD_DEVIATION 15.4 |
| Body Mass Index (BMI) | 24.7 kg/m^2 STANDARD_DEVIATION 4.65 | 24.5 kg/m^2 STANDARD_DEVIATION 3.7 | 24.7 kg/m^2 STANDARD_DEVIATION 5.06 | 25.9 kg/m^2 STANDARD_DEVIATION 4.8 | 25.1 kg/m^2 STANDARD_DEVIATION 4.54 | 25.0 kg/m^2 STANDARD_DEVIATION 4.56 |
| Body weight | 71.5 kg STANDARD_DEVIATION 14.85 | 73.3 kg STANDARD_DEVIATION 13.15 | 73.1 kg STANDARD_DEVIATION 17.53 | 78.1 kg STANDARD_DEVIATION 12.89 | 75.5 kg STANDARD_DEVIATION 16.7 | 74.3 kg STANDARD_DEVIATION 15.14 |
| Concomitant Ulcerative Colitis(UC) medication 5-aminosalicylic acid (5-ASA) | 38 Participants | 33 Participants | 33 Participants | 39 Participants | 35 Participants | 178 Participants |
| Concomitant Ulcerative Colitis(UC) medication Corticosteroids | 13 Participants | 17 Participants | 14 Participants | 17 Participants | 18 Participants | 79 Participants |
| Concomitant Ulcerative Colitis(UC) medication Thiopurines | 6 Participants | 9 Participants | 10 Participants | 7 Participants | 9 Participants | 41 Participants |
| C-reactive protein (CRP) | 4.9 mg/L STANDARD_DEVIATION 5 | 7.1 mg/L STANDARD_DEVIATION 9.5 | 9.7 mg/L STANDARD_DEVIATION 16.9 | 8.1 mg/L STANDARD_DEVIATION 12.1 | 7.6 mg/L STANDARD_DEVIATION 16.2 | 7.5 mg/L STANDARD_DEVIATION 11.9 |
| Disease extent Descending colon | 21 Participants | 23 Participants | 19 Participants | 23 Participants | 17 Participants | 103 Participants |
| Disease extent Rectosigmoid | 22 Participants | 19 Participants | 23 Participants | 21 Participants | 23 Participants | 108 Participants |
| Duration of Ulcerative Colitis (UC) | 8.46 years STANDARD_DEVIATION 7.431 | 7.89 years STANDARD_DEVIATION 6.83 | 8.14 years STANDARD_DEVIATION 6.772 | 7.36 years STANDARD_DEVIATION 7.277 | 7.88 years STANDARD_DEVIATION 6.48 | 7.94 years STANDARD_DEVIATION 6.92 |
| Faecal calprotectin | 3389 mg/kg STANDARD_DEVIATION 5669 | 2654 mg/kg STANDARD_DEVIATION 4294 | 3730 mg/kg STANDARD_DEVIATION 4954 | 3263 mg/kg STANDARD_DEVIATION 5379 | 3563 mg/kg STANDARD_DEVIATION 6256 | 3313 mg/kg STANDARD_DEVIATION 5292 |
| Mayo endoscopic subscore 2 | 17 Participants | 17 Participants | 19 Participants | 20 Participants | 18 Participants | 91 Participants |
| Mayo endoscopic subscore 3 | 26 Participants | 25 Participants | 23 Participants | 24 Participants | 22 Participants | 120 Participants |
| Mayo Physicians Global Assessment (PGA) subscore 1 | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 2 Participants | 16 Participants |
| Mayo Physicians Global Assessment (PGA) subscore 2 | 34 Participants | 32 Participants | 31 Participants | 31 Participants | 32 Participants | 160 Participants |
| Mayo Physicians Global Assessment (PGA) subscore 3 | 5 Participants | 7 Participants | 7 Participants | 10 Participants | 6 Participants | 35 Participants |
| Mayo rectal bleeding subscore 0 | 4 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 9 Participants |
| Mayo rectal bleeding subscore 1 | 9 Participants | 16 Participants | 17 Participants | 15 Participants | 11 Participants | 68 Participants |
| Mayo rectal bleeding subscore 2 | 26 Participants | 21 Participants | 21 Participants | 22 Participants | 27 Participants | 117 Participants |
| Mayo rectal bleeding subscore 3 | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 2 Participants | 17 Participants |
| Mayo score | 8.0 scores on a scale STANDARD_DEVIATION 1.8 | 8.5 scores on a scale STANDARD_DEVIATION 1.3 | 8.3 scores on a scale STANDARD_DEVIATION 1.7 | 8.3 scores on a scale STANDARD_DEVIATION 1.6 | 8.5 scores on a scale STANDARD_DEVIATION 1.2 | 8.3 scores on a scale STANDARD_DEVIATION 1.5 |
| Mayo stool frequency subscore 0 | 8 Participants | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 19 Participants |
| Mayo stool frequency subscore 1 | 11 Participants | 8 Participants | 8 Participants | 10 Participants | 7 Participants | 44 Participants |
| Mayo stool frequency subscore 2 | 10 Participants | 17 Participants | 16 Participants | 10 Participants | 17 Participants | 70 Participants |
| Mayo stool frequency subscore 3 | 14 Participants | 14 Participants | 16 Participants | 20 Participants | 14 Participants | 78 Participants |
| Nancy Histological Index (NHI) score 0 | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Nancy Histological Index (NHI) score 1 | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants |
| Nancy Histological Index (NHI) score 2 | 4 Participants | 3 Participants | 6 Participants | 3 Participants | 4 Participants | 20 Participants |
| Nancy Histological Index (NHI) score 3 | 18 Participants | 17 Participants | 14 Participants | 13 Participants | 14 Participants | 76 Participants |
| Nancy Histological Index (NHI) score 4 | 19 Participants | 18 Participants | 21 Participants | 25 Participants | 22 Participants | 105 Participants |
| Previous UC therapy Anti-TNF Therapy | 10 Participants | 9 Participants | 12 Participants | 8 Participants | 9 Participants | 48 Participants |
| Previous UC therapy Thiopurines | 40 Participants | 42 Participants | 40 Participants | 42 Participants | 39 Participants | 203 Participants |
| Previous UC therapy Tofacitinib | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Previous UC therapy Vedolizumab | 3 Participants | 5 Participants | 3 Participants | 0 Participants | 4 Participants | 15 Participants |
| Race/Ethnicity, Customized Ethnicity : Asian | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity : Other | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity : White | 42 Participants | 40 Participants | 39 Participants | 42 Participants | 39 Participants | 202 Participants |
| Sex: Female, Male Female | 23 Participants | 16 Participants | 18 Participants | 11 Participants | 14 Participants | 82 Participants |
| Sex: Female, Male Male | 20 Participants | 26 Participants | 24 Participants | 33 Participants | 26 Participants | 129 Participants |
| Stool frequency per day | 5.0 Stools per day STANDARD_DEVIATION 1.83 | 5.7 Stools per day STANDARD_DEVIATION 2.73 | 5.7 Stools per day STANDARD_DEVIATION 2.56 | 5.9 Stools per day STANDARD_DEVIATION 3.04 | 6.3 Stools per day STANDARD_DEVIATION 2.93 | 5.7 Stools per day STANDARD_DEVIATION 2.62 |
| Tobacco use at screening Current smoker | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 8 Participants |
| Tobacco use at screening Former smoker | 13 Participants | 10 Participants | 11 Participants | 11 Participants | 9 Participants | 54 Participants |
| Tobacco use at screening Never smoked | 28 Participants | 30 Participants | 30 Participants | 31 Participants | 30 Participants | 149 Participants |
| Total inflammatory Bowel Disease Questionnaire score (IBDQ) | 140.1 scores on a scale STANDARD_DEVIATION 32.46 | 131.5 scores on a scale STANDARD_DEVIATION 36.64 | 120.9 scores on a scale STANDARD_DEVIATION 34.81 | 133.9 scores on a scale STANDARD_DEVIATION 28.58 | 131.9 scores on a scale STANDARD_DEVIATION 28.11 | 131.7 scores on a scale STANDARD_DEVIATION 32.59 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 43 | 0 / 42 | 0 / 42 | 1 / 44 |
| other Total, other adverse events | 5 / 40 | 12 / 43 | 8 / 42 | 10 / 42 | 11 / 44 |
| serious Total, serious adverse events | 2 / 40 | 0 / 43 | 4 / 42 | 2 / 42 | 2 / 44 |
Outcome results
Primary
Clinical Remission
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cobitolimod Dose 2x31 mg | Clinical Remission | 5 Participants |
| Cobitolimod Dose 2x125 mg | Clinical Remission | 2 Participants |
| Cobitolimod Dose 2x250 mg | Clinical Remission | 9 Participants |
| Cobitolimod Dose 4x125 mg | Clinical Remission | 4 Participants |
| Placebo | Clinical Remission | 3 Participants |
p-value: 0.180680% CI: [0.75, 5.47]Cochran-Mantel-Haenszel
p-value: 0.664980% CI: [0.2, 2.24]Cochran-Mantel-Haenszel
p-value: 0.024780% CI: [1.53, 9.47]Cochran-Mantel-Haenszel
p-value: 0.327980% CI: [0.52, 3.88]Cochran-Mantel-Haenszel
Secondary
Clinical Response
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cobitolimod Dose 2x31 mg | Clinical Response | 17 Participants |
| Cobitolimod Dose 2x125 mg | Clinical Response | 18 Participants |
| Cobitolimod Dose 2x250 mg | Clinical Response | 20 Participants |
| Cobitolimod Dose 4x125 mg | Clinical Response | 15 Participants |
| Placebo | Clinical Response | 20 Participants |
p-value: 0.632680% CI: [0.5, 1.5]Cochran-Mantel-Haenszel
p-value: 0.712780% CI: [0.45, 1.37]Cochran-Mantel-Haenszel
p-value: 0.265880% CI: [0.75, 2.34]Cochran-Mantel-Haenszel
p-value: 0.830180% CI: [0.36, 1.16]Cochran-Mantel-Haenszel
Secondary
Endoscopic Remission
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cobitolimod Dose 2x31 mg | Endoscopic Remission | 7 Participants |
| Cobitolimod Dose 2x125 mg | Endoscopic Remission | 5 Participants |
| Cobitolimod Dose 2x250 mg | Endoscopic Remission | 15 Participants |
| Cobitolimod Dose 4x125 mg | Endoscopic Remission | 10 Participants |
| Placebo | Endoscopic Remission | 12 Participants |
p-value: 0.799480% CI: [0.32, 1.27]Cochran-Mantel-Haenszel
p-value: 0.966580% CI: [0.16, 0.72]Cochran-Mantel-Haenszel
p-value: 0.204980% CI: [0.8, 2.82]Cochran-Mantel-Haenszel
p-value: 0.650480% CI: [0.42, 1.6]Cochran-Mantel-Haenszel
Secondary
Histological Remission
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cobitolimod Dose 2x31 mg | Histological Remission | 4 Participants |
| Cobitolimod Dose 2x125 mg | Histological Remission | 5 Participants |
| Cobitolimod Dose 2x250 mg | Histological Remission | 8 Participants |
| Cobitolimod Dose 4x125 mg | Histological Remission | 7 Participants |
| Placebo | Histological Remission | 10 Participants |
p-value: 0.920780% CI: [0.18, 0.93]Cochran-Mantel-Haenszel
p-value: 0.922880% CI: [0.19, 0.92]Cochran-Mantel-Haenszel
p-value: 0.663680% CI: [0.39, 1.61]Cochran-Mantel-Haenszel
p-value: 0.744980% CI: [0.34, 1.41]Cochran-Mantel-Haenszel
Secondary
Modified Clinical Remission
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cobitolimod Dose 2x31 mg | Modified Clinical Remission | 5 Participants |
| Cobitolimod Dose 2x125 mg | Modified Clinical Remission | 1 Participants |
| Cobitolimod Dose 2x250 mg | Modified Clinical Remission | 7 Participants |
| Cobitolimod Dose 4x125 mg | Modified Clinical Remission | 3 Participants |
| Placebo | Modified Clinical Remission | 3 Participants |
p-value: 0.211580% CI: [0.69, 4.99]Cochran-Mantel-Haenszel
p-value: 0.849880% CI: [0.06, 1.34]Cochran-Mantel-Haenszel
p-value: 0.097780% CI: [1.01, 6.62]Cochran-Mantel-Haenszel
p-value: 0.52280% CI: [0.32, 2.84]Cochran-Mantel-Haenszel
Secondary
Symptomatic Remission
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cobitolimod Dose 2x31 mg | Symptomatic Remission | 10 Participants |
| Cobitolimod Dose 2x125 mg | Symptomatic Remission | 11 Participants |
| Cobitolimod Dose 2x250 mg | Symptomatic Remission | 13 Participants |
| Cobitolimod Dose 4x125 mg | Symptomatic Remission | 10 Participants |
| Placebo | Symptomatic Remission | 9 Participants |
p-value: 0.233580% CI: [0.74, 2.94]Cochran-Mantel-Haenszel
p-value: 0.251180% CI: [0.73, 2.69]Cochran-Mantel-Haenszel
p-value: 0.116280% CI: [0.96, 3.52]Cochran-Mantel-Haenszel
p-value: 0.346780% CI: [0.63, 2.4]Cochran-Mantel-Haenszel