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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004217-26 | EudraCT Number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cobitolimod Dose 2x31 mg | Experimental | Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions |
|
| Cobitolimod Dose 2x125 mg | Experimental | Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions |
|
| Cobitolimod Dose 2x250 mg | Experimental | Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions |
|
| Cobitolimod Dose 4x125 mg | Experimental | Dose 125 mg of cobitolimod, at 4 occasions |
|
| Placebo | Placebo Comparator | Placebo at four occasions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cobitolimod | Drug | Rectal administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 weeks after first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 6 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja Atreya | Friedrich-Alexander University Erlangen-Nuremberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 | Prague | Czechia | ||||
| 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33031757 | Derived | Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hebuterne 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. |
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1 patient in the 2x31 mg and one patient in the 4x125 mg was never treated with study drug and excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cobitolimod Dose 2x31 mg | Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration |
| FG001 | Cobitolimod Dose 2x125 mg | Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2017 |
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|
| Placebo | Drug | Solution manufactured to mimic cobitolimod |
|
|
| 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) | Week 6 |
| 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) | Week 6 |
| 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) | Week 6 |
| Histological Remission | Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1 | Week 6 |
| Amiens |
| France |
| 3 | Caen | France |
| 4 | Clichy | France |
| 5 | Grenoble | France |
| 6 | Nice | France |
| 7 | Pierre-Bénite | France |
| 8 | Saint-Etienne | France |
| 9 | Toulouse | France |
| 10 | Vandœuvre-lès-Nancy | France |
| 11 | Augsburg | Germany |
| 12 | Berlin | Germany |
| 13 | Erlangen | Germany |
| 14 | Hamburg | Germany |
| 15 | Hanover | Germany |
| 16 | Heidelberg | Germany |
| 17 | Leipzig | Germany |
| 18 | Lüneburg | Germany |
| 19 | Mannheim | Germany |
| 20 | München | Germany |
| 22 | Békéscsaba | Hungary |
| 21 | Budapest | Hungary |
| 23 | Debrecen | Hungary |
| 24 | Mosonmagyaróvár | Hungary |
| 25 | Pécs | Hungary |
| 26 | Częstochowa | Poland |
| 27 | Krakow | Poland |
| 28 | Ksawerów | Poland |
| 33 | Lodz | Poland |
| 29 | Lublin | Poland |
| 30 | Poznan | Poland |
| 31 | Sopot | Poland |
| 32 | Warsaw | Poland |
| 33 | Wroclaw | Poland |
| 32 | Włocławek | Poland |
| 34 | Cheboksary | Russia |
| 36 | Kazan' | Russia |
| 37 | Kirov | Russia |
| 38 | Moscow | Russia |
| 39 | Novosibirsk | Russia |
| 40 | Ryazan | Russia |
| 41 | Saint Petersburg | Russia |
| 42 | Stavropol | Russia |
| 43 | Tver' | Russia |
| 44 | Ufa | Russia |
| 35 | Yekaterinburg | Russia |
| 45 | Belgrade | Serbia |
| 46 | Ferrol | Spain |
| 47 | Fuenlabrada | Spain |
| 48 | Madrid | Spain |
| 49 | Seville | Spain |
| 50 | Valencia | Spain |
| 51 | Uppsala | Sweden |
| 52 | Chernivtsi | Ukraine |
| 53 | Dnipro | Ukraine |
| 54 | Ivano-Frankivsk | Ukraine |
| 55 | Kharkiv | Ukraine |
| 56 | Kiev | Ukraine |
| 57 | Lutsk | Ukraine |
| 58 | Lviv | Ukraine |
| 59 | Odesa | Ukraine |
| 60 | Sumy | Ukraine |
| 62 | Uzhhorod | Ukraine |
| 61 | Zaporizhzhya | Ukraine |
| FG002 | Cobitolimod Dose 2x250 mg | Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration |
| FG003 | Cobitolimod Dose 4x125 mg | Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration |
| FG004 | Placebo | Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod |
| Completed Week 6 | Completed Week 6 |
|
| COMPLETED | Completed Week 10 |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cobitolimod Dose 2x31 mg | Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration |
| BG001 | Cobitolimod Dose 2x125 mg | Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration |
| BG002 | Cobitolimod Dose 2x250 mg | Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration |
| BG003 | Cobitolimod Dose 4x125 mg | Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration |
| BG004 | Placebo | Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Body weight | Mean | Standard Deviation | kg |
| ||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||
| Tobacco use at screening | Count of Participants | Participants |
| |||||||||||
| Total inflammatory Bowel Disease Questionnaire score (IBDQ) | 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. | Mean | Standard Deviation | scores on a scale |
| |||||||||
| Duration of Ulcerative Colitis (UC) | Mean | Standard Deviation | years |
| ||||||||||
| Stool frequency per day | Mean | Standard Deviation | Stools per day |
| ||||||||||
| Mayo score | 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. | Mean | Standard Deviation | scores on a scale |
| |||||||||
| Mayo stool frequency subscore | 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. | Count of Participants | Participants |
| ||||||||||
| Mayo rectal bleeding subscore | 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. | Count of Participants | Participants |
| ||||||||||
| Mayo endoscopic subscore | Mayo endoscopic subscore: 2=moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). | Count of Participants | Participants |
| ||||||||||
| Mayo Physicians Global Assessment (PGA) subscore | Mayo PGA subscore:1=mild disease, 2=moderate disease, 3=severe disease. | Count of Participants | Participants |
| ||||||||||
| Disease extent | Count of Participants | Participants |
| |||||||||||
| Nancy Histological Index (NHI) score | 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. | Missing NHI score for 2 patients | Count of Participants | Participants |
| |||||||||
| Faecal calprotectin | Mean | Standard Deviation | mg/kg |
| ||||||||||
| C-reactive protein (CRP) | Mean | Standard Deviation | mg/L |
| ||||||||||
| Concomitant Ulcerative Colitis(UC) medication | Count of Participants | Participants |
| |||||||||||
| Previous UC therapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Count of Participants | Participants | 6 weeks after first treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Count of Participants | Participants | Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Count of Participants | Participants | Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Count of Participants | Participants | Week 6 |
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| 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) | 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. | Posted | Count of Participants | Participants | Week 6 |
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| 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 | 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. | Posted | Count of Participants | Participants | Week 6 |
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cobitolimod Dose 2x31 mg | Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration | 0 | 40 | 2 | 40 | 5 | 40 |
| EG001 | Cobitolimod Dose 2x125 mg | Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration | 0 | 43 | 0 | 43 | 12 | 43 |
| EG002 | Cobitolimod Dose 2x250 mg | Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration | 0 | 42 | 4 | 42 | 8 | 42 |
| EG003 | Cobitolimod Dose 4x125 mg | Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration | 0 | 42 | 2 | 42 | 10 | 42 |
| EG004 | Placebo | Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod | 1 | 44 | 2 | 44 | 11 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative colitis | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative colitis | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Viral upper respiratory infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Faecal calprotectin increased | Investigations | MedDRA (20.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karin Arnesson, Clinical Trial Manager | InDex Pharmaceuticals | +46 8 122 038 57 | karin.arnesson@indexpharma.com |
| Nov 9, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D005767 | Gastrointestinal Diseases |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000711771 | cobitolimod |
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| Ethnicity : White |
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| Ethnicity : Other |
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| Current smoker |
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| Former smoker |
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|
| 1 |
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| 2 |
|
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| 3 |
|
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| 1 |
|
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| 2 |
|
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| 3 |
|
|
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| 3 |
|
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| 2 |
|
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| 3 |
|
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| Descending colon |
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| 1 |
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| 2 |
|
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| 3 |
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| 4 |
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| Corticosteroids |
|
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| Thiopurines |
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| Anti-TNF Therapy |
|
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| Vedolizumab |
|
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| Tofacitinib |
|
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| 0.6649 |
one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant. |
| Odds Ratio (OR) |
| 0.7 |
| 2-Sided |
| 80 |
| 0.20 |
| 2.24 |
| Superiority |
| Cochran-Mantel-Haenszel | 0.0247 | one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant. | Odds Ratio (OR) | 3.8 | 2-Sided | 80 | 1.53 | 9.47 | Superiority |
| Cochran-Mantel-Haenszel | 0.3279 | one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant. | Odds Ratio (OR) | 1.4 | 2-Sided | 80 | 0.52 | 3.88 | Superiority |
| OG003 | Cobitolimod Dose 4x125 mg | Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration |
| OG004 | Placebo | Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod |
|
|
|
| OG003 | Cobitolimod Dose 4x125 mg | Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration |
| OG004 | Placebo | Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod |
|
|
|
| OG003 | Cobitolimod Dose 4x125 mg | Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration |
| OG004 | Placebo | Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod |
|
|
|
| Cobitolimod Dose 4x125 mg |
Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration |
| OG004 | Placebo | Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod |
|
|
|
Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration |
| OG004 | Placebo | Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod |
|
|
|