Moderate to Severe left-sided Active Ulcerative Colitis
Conditions
Interventions
Product Name: Cobitolimod
Product Code: DIMS0150
Pharmaceutical Form: Rectal solution
INN or Proposed INN: Cobitolimod
CAS Number: 1527479-55-5
Current Sponsor code: DIMS0150
Other descriptive name: D
Sponsors
InDex Pharmaceuticals AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female = 18 years of age 2. Established diagnosis of UC, with minimum time from diagnosis of =3 months 3. Moderately to severely active left sided UC (disease should extend 15 cm or more above the anal verge and not beyond the splenic flexure) determined by a Modified Mayo score (excluding the friability at grade 1 for the endoscopic sub score) of 6 to 12 with an endoscopic sub score =2 assessed by central reading of endoscopy performed at screening visit 1b, and no other individual sub score =65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: 1. Suspicion of differential diagnosis such as; Crohn’s enterocolitis, ischaemic colitis, radiation colitis, indeterminate colitis, infectious colitis, diverticular disease, associated colitis, microscopic colitis, massive pseudopolyposis or non-passable stenosis 2. Acute fulminant UC and/or signs of systemic toxicity 3. UC limited to the rectum (disease which extend <15 cm above the anal verge) 4. History of malignancy, except for: • Treated (cured) basal cell or squamous cell in situ carcinoma • Treated (cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years prior to the screening visit 1a 5. History or presence of any clinically significant disorder that, in opinion of the investigator, could impact on patient’s possibility to adhere to the protocol and protocol procedures or would confound the study result or compromise patient safety 6. Concomitant treatment with cyclosporine, methotrexate, tacrolimus TNF-a inhibitors, anti-integrins or similar immunosuppressants and immunomodulators at enrolment. Any prior treatment with such drugs must have been discontinued at least 8 weeks prior to visit 1a or have non-measurable serum concentration levels 7. Treatment with rectal GCS, 5-ASA/SP or tacrolimus within 2 Weeks before visit 1b 8. Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within two weeks prior to visit 1a (one short treatment regime for antibiotics and occasional use of NSAIDS are allowed) 9. Serious active infection 10. Gastrointestinal infections including positive Clostridium difficile stool assay 11. Currently receiving parenteral nutrition or blood transfusions 12. Females who are lactating or have a positive serum pregnancy test during the screening period 13. Women of childbearing potential not using highly effective (failure rate < 1%) contraceptive methods throughout the duration of the study 14. Concurrent participation in another clinical study with investigational therapy or previous use of investigational therapy within 5 half-lives and within at least 30 days after last treatment of the experimental product prior to enrolment. 15. Previous exposure to cobitolimod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo with regard to clinical remission 6 weeks after first treatment, in patients with moderate to severe active ulcerative colitis (UC).;Secondary Objective: • To evaluate the safety and tolerability of cobitolimod. • To evaluate the efficacy of cobitolimod treatment compared to placebo in clinical remission, clinical response and clinical symptoms. • To evaluate the efficacy of cobitolimod treatment compared to placebo in endoscopic and histological remission and response. • To evaluate the effect of cobitolimod on quality of life (QOL). ;Primary end point(s): Proportion of patients with clinical remission at Week 6, 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).;Timepoint(s) of evaluation of this end point: Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with symptomatic remission at Week 6, 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) [PRO2] • Proportion of patients with absence of rectal bleeding at Week 6, defined by the Mayo sub score rectal bleeding of 0 • Proportion of patients with normal or enhanced stool frequency at Week 6, defined by the Mayo sub score stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0) • Proportion of patients with endoscopic remission at Week 6, defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability) • Proportion of patients with histological remission at Week 6, defined by the Nancy histological index of grade 0 or 1 • Proportion of patients with complete histological remission at Week 6, defined by the Nancy histological index grade of 0 • Proportion of patients with histological response at Week 6, defined by the Nancy histological index score of =2 (if 2 then with at least one point decrease from Baseline, Week 0) • Proportion of patients with endoscopic and histological remission at Week 6 • Proportion of patients with symptomatic remission at Week 4, 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) [PRO2] • Proportion of patients with absence of rectal bleeding at Week 4, defined by the Mayo sub score rectal bleeding of 0 • Proportion of patients with normal or enhanced stool frequency at Week 4, defined by the Mayo sub score stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0) • Proportion of patients with modified clinical remission at Week 6, 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 Base | — |
Countries
Czech Republic, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Ukraine
Contacts
Public ContactKarin Arnesson
InDex Pharmaceuticals AB
Outcome results
None listed