Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Code: DIMS0150
Pharmaceutical Form: Rectal solution
INN or Proposed INN: Cobitolimod
CAS Number: 1527479-55-5
Current Sponsor code: SUB189302
Other descriptive name: DIMS0150
Concentration uni
Sponsors
InDex Pharmaceuticals AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give written informed consent for participation in the study. 2. Male or female patient aged =18 years. 3. Established diagnosis of UC, with minimum time from diagnosis of at least 3 months before screening. 4. Moderate to severe active UC (disease should extend 15 cm or more above the anal verge) determined by a 3-component Mayo score of 5 to 9 with an endoscopic subscore =2 (in sigmoid or descending segments) assessed by the Investigator’s reading of the endoscopy, and with a stool frequency and rectal bleeding subscores each =1. 5. Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. 6. Women only: WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the patient) or must agree to use a highly effective method of contraception with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 2
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, toxic megacolon and/or signs of systemic toxicity. 3. Have failed treatment with more than three advanced therapies (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab or tofacitinib) of two different therapeutic classes (anti-TNF, anti-integrins, anti-IL12/23, JAKinhibitors, or other approved advanced therapies for UC). 4. Have had surgery for treatment of UC. 5. History of malignancy, unless treated with no relapse of the disease and = 5 years since last treatment (cured) or treated (cured) basal cell or squamous cell in situ carcinoma. 6. Serious known active infection including history of latent or active tuberculosis, documented history of past or current tuberculosis, or living with or having frequent close contact with people with active tuberculosis or with a positive tuberculosis test according to current regulations for 12 weeks preceding randomisation. Serious infections include, but is not limited to, HIV, hepatitis B, or hepatitis C infections. 7. Gastrointestinal infections including positive Clostridium difficile stool assay (laboratory reports must be available in accordance with normal clinic practice, to confirm that the current episode of disease exacerbation is not due to infection). 8. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study. 9. Concomitant or planned treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies such as infliximab, adalimumab, golimumab, vedolizumab,ustekinumab or tofacitinib, or similar immunosuppressants and immunomodulators at enrolment. Any prior treatment with such drugs must have been discontinued at least 8 weeks prior to Visit 1 (except for ustekinumab, which must have been discontinued at least 12 weeks prior to Visit 1) or have non-measurable serum concentration levels. 10. Treatment with rectal GCS, 5-ASA/SP or tacrolimus within 2 weeks before Visit 1. 11. Long-term treatment (>14 days) with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to Visit 1 (one short treatment regimen for antibiotics, occasional use of NSAIDs and low dose NSAIDs as prophylactic therapy is allowed). 12. Females who are lactating or have a positive serum pregnancy test at Visit 1. 13. Any planned major surgery within the duration of the study. 14. Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. 15. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening. 16. Investigator considers the participant unlikely to comply with study procedures, restrictions and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess PK properties of cobitolimod in plasma after administration of cobitolimod enema in participants with active UC and in remission.;Secondary Objective: To assess safety and tolerability of cobitolimod after administration of cobitolimod enema in participants with active UC and in remission. To assess blood biomarkers of cobitolimod after administration of cobitolimod enema in participants with active UC and in remission. ;Primary end point(s): • Maximum observed plasma concentration (Cmax) • Time to Cmax (Tmax) • Area under the curve from 0 to timepoint t (AUCt) • AUC from 0 to infinity (AUCinf) • Half-life (T1/2);Timepoint(s) of evaluation of this end point: Visit 2, visit 3 and visit 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Frequency, intensity and seriousness of adverse events (AEs) • Clinically significant changes in electrocardiogram (ECG), vital signs, safety laboratory parameters, physical examinations • Significant changes in blood biomarkers ;Timepoint(s) of evaluation of this end point: All visits: Visit 1 - visit 5 | — |
Countries
Sweden
Contacts
Public ContactJohan Levin
InDex Pharmaceuticals AB
Outcome results
None listed