Ulcerative ColitisPhase 1NCT05404074
Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis
A Phase 1 study testing Cobitolimod 500mg in people with Ulcerative Colitis, run by InDex Pharmaceuticals at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate the PK, safety and tolerability of cobitolimod ememas (500mg/50mL) given to participants with active left-sided UC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Cobitolimod 500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 22 Nov 2021to 30 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study.
- Male or female participant aged ≥18 years.
- Established diagnosis of UC, with minimum time from diagnosis of at least 3 months before screening.
- Moderate to severe active left-sided UC (disease should extend 15 cm or more above the anal verge and may extend beyond the splenic flexure) 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.
- Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- Women only: WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the participant) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose.
- Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] 25-140 IE/L is confirmatory)
Who cannot join
- 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, JAK-inhibitors, 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 e.g., any positive result on screening for serum hepatitis B surface antigen, hepatitis C virus antibodies and HIV.
- 7. Gastrointestinal infections including positive Clostridium difficile stool assay (local 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
CTC, Clinical Trial Consultants AB
Uppsala
Per Hellström, Prof
About this study
The purpose of the study is to evaluate the PK, safety and tolerability of cobitolimod ememas (500mg/50mL) given to participants with active left-sided UC.
Read the detailed description
This is a single centre phase 1b study in participants with moderate to severe active UC designed to provide important supplementary data of the PK profile of cobitolimod.
- Conditions
- Ulcerative Colitis
- Being tested
- Cobitolimod 500mg
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cobitolimod 500mgDrug
Also called Kappaproct
Rectal administration
| Study group | Role | What they receive |
|---|---|---|
| Cobitolimod 500mg | Experimental | 2-3 single doses of rectal cobitolimod (500mg/50ml) over 3-6 weeks Receives: Drug: Cobitolimod 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentrations (Cmax)
Maximum observed plasma concentrations (Cmax)
Measured: Week 6
Time to Cmax (Tmax)
Time to Cmax (Tmax)
Measured: Week 6
Area under the curve from 0 to timepoint t (AUCt)
Area under the curve from 0 to timepoint t (AUCt)
Measured: week 6
AUC from 0 to infinity (AUCinf)
AUC from 0 to infinity (AUCinf)
Measured: week 6
Half-life (T1/2)
Half-life (T1/2)
Measured: week 6
Secondary outcomes (3)
Frequency, intensity and seriousness of adverse events (AEs)
Frequency, intensity and seriousness of adverse events (AEs)
Measured: week 8
Clinically significant changes in electrocardiogram (ECG), vital signs, safety laboratory
Abnormal post-dose findings assessed by the Investigator as clinically significant will be reported as AEs.
Measured: week 8
Significant changes in blood biomarkers
The difference between biomarker expression before and after treatment will be reported.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start22 Nov 2021
- Primary completion15 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InDex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Levin, Study director, InDex Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404074
- Sponsor's protocol ID
- CSUC-02/21
- Status last verified
- Jun 2022
- First submitted
- 17 May 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05404074
- Acronym / sponsor ID
- CSUC-02/21
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- InDex PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the PK, safety and tolerability of cobitolimod ememas (500mg/50mL) given to participants with active left-sided UC.
Detailed description
This is a single centre phase 1b study in participants with moderate to severe active UC designed to provide important supplementary data of the PK profile of cobitolimod.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cobitolimod 500mg | Experimental | Drug: Cobitolimod 500mg2-3 single doses of rectal cobitolimod (500mg/50ml) over 3-6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to give written informed consent for participation in the study.
- Male or female participant aged ≥18 years.
- Established diagnosis of UC, with minimum time from diagnosis of at least 3 months before screening.
- Moderate to severe active left-sided UC (disease should extend 15 cm or more above the anal verge and may extend beyond the splenic flexure) 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.
- Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
Key exclusion criteria (13 listed)
- 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, JAK-inhibitors, 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 e.g., any positive result on screening for serum hepatitis B surface antigen, hepatitis C virus antibodies and HIV.
- 7. Gastrointestinal infections including positive Clostridium difficile stool assay (local 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cobitolimod 500mgAlso: KappaproctRectal administration | Drug | Cobitolimod 500mg |
Primary outcome
Maximum observed plasma concentrations (Cmax)
Time frame: Week 6
Maximum observed plasma concentrations (Cmax)
Time to Cmax (Tmax)
Time frame: Week 6
Time to Cmax (Tmax)
Area under the curve from 0 to timepoint t (AUCt)
Time frame: week 6
Area under the curve from 0 to timepoint t (AUCt)
AUC from 0 to infinity (AUCinf)
Time frame: week 6
AUC from 0 to infinity (AUCinf)
Half-life (T1/2)
Time frame: week 6
Half-life (T1/2)
3 secondary outcomes
Frequency, intensity and seriousness of adverse events (AEs)
Time frame: week 8
Clinically significant changes in electrocardiogram (ECG), vital signs, safety laboratory
Time frame: week 8
Significant changes in blood biomarkers
Time frame: week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Levin study director
InDex Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cobitolimod 500mg in people with Ulcerative Colitis, run by InDex Pharmaceuticals at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Levin, PM (+46 8 122 038 56, johan.levin@indexpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentrations (Cmax) (time frame: Week 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.