Ulcerative ColitisPhase 2NCT06353828
Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients
A Phase 2 study testing CBD, synthetic form in people with Ulcerative Colitis, run by CannaMore Biotechs at 1 site in Israel.
Trial summary
Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation… 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?
- CBD, synthetic form
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2023to 1 Apr 2025
- Phase
- Phase 2
- 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
- Age ≥18 years
- Diagnosis of UC at least 3 months prior to the Screening Visit
- Patients who were not treated rectally for UC in the last 3 days.
- UC patients with active disease and being treated with stable doses of biologics (at least 2 months), and/or steroids (at least 1 months) and/or oral mesalazine (at least 2 months at stable dose (4 gr)) or non-treated patients)
- Full Mayo score ≥4 to < 9 (range: 0-12) prior to enrolment in the study
- Patients that did not respond to Mesalamine treatment.
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- Non-pregnant (via negative pregnancy test)/non-breast-feeding women and women with no intention to become pregnant/to breast-feed during the term of the trial and for at least one month after cessation of IcBD-01 treatment
- Male subject with female partner(s) of child-bearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for one month after final IMP administration.
- Subject able to provide written informed consent
- Must be able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Diagnosis of severe extensive pancolitis
- Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis
- Complete resection of the colon with the need of a pouch
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 4 weeks of screening
- Sexual transmitted diseases
- Using rectal formulations (such as Mesalazine) for the last 3 days
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- Subjects who have received any investigational drug or used investigational device in the last 2 months
- Serious psychiatric or psychological disorders
- Active consumption of illicit drugs including cannabis or derivatives for at least 1 months prior to the study
- Patients with short bowel syndrome, symptomatic stricture, abscess, recent history (within the previous 3 months) of abdominal surgery
- Patients with significant cardiac, hepatic, respiratory disease comorbidities or active malignancy
- Renal comorbidity: eGFR< 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2)
- Patient who is taking immunomodulatory medications for other indication(s)
- Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding or male subjects with female partners who intend to get pregnant or breastfeed during the trial period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of IcBD-01 Enema for the Treatment of Active Ulcerative Colitis
Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation, including IBD models.
Based on positive safety and initial efficacy profiles of CBD found in IBD animal and clinical studies, the main aim of this study is to evaluate the safety, tolerability and efficacy of a novel enema formulation of CBD for the treatment of active ulcerative proctitis.
Read the detailed description
This study consists of 2 stages:
Stage 1. Feasibility - Open label stage:
Up to fourteen patients will be enrolled in this stage and receive a CBD enema formulation for 12 weeks treatment period.
If results of this stage prove to be safe and with clinical effect (reduction of 3 points in full Mayo score in at least 50% of patients), the study will proceed to stage 2.
Stage 2. Randomized, placebo controlled blinded stage:
Subjects will be randomized in a 2:1 ratio and receive the drug/placebo enema for a 12 weeks treatment period.
Patients will be assessed for full Mayo score on visit 1 and week 12, and partial Mayo score every visit. Patients will assessed by a clinician using the self reported outcome (PRO) scale every visit. Sigmoidoscopy will be performed at baseline and week 12.
- Conditions
- Ulcerative Colitis
- Being tested
- CBD, synthetic form, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD, synthetic formDrug
Cannabidiol enema
PlaceboDrug
placebo enema
| Study group | Role | What they receive |
|---|---|---|
| IcBD-01 | Experimental | IcBD-01 is a novel Cannabidiol enema formulation Receives: Drug: CBD, synthetic form |
| placebo | Placebo comparator | placebo enema formulation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Full Mayo Score
The Mayo Score is used to assess the severity of ulcerative colitis and can range from 0-12, with higher scores indicating worse severity.
Measured: 12 weeks
Secondary outcomes (4)
Change in Partial Mayo Score
The partial Mayo Score is used to assess the severity of UC and does not include the endoscopic parameter. Can range from 0-9, with higher scores indicating worse severity.
Measured: 12 weeks
Change in patient reported outcome (PRO-UC)
PRO-UC Diary is a tool to quantify the patient perspective in terms of how they feel and function. Can range from 0-20, with higher scores indicating worse severity
Measured: 12 weeks
Change in endoscopic Mayo subscore in distal 15 cm of anus
Efficacy will be determined through the use of the Mayo Endoscopic Subscore.
Measured: 12 weeks
Change in the length of the inflamed colon
Length of inflamed colon (Mayo subscore) will be measured through endoscopy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Mar 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CannaMore Biotechs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353828
- Sponsor's protocol ID
- ICBD-UC-01
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of IcBD-01 Enema for the Treatment of Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06353828
- Acronym / sponsor ID
- ICBD-UC-01
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- CannaMore BiotechsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 9 Apr 2024 (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.
Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation, including IBD models.
Based on positive safety and initial efficacy profiles of CBD found in IBD animal and clinical studies, the main aim of this study is to evaluate the safety, tolerability and efficacy of a novel enema formulation of CBD for the treatment of active ulcerative proctitis.
Detailed description
This study consists of 2 stages:
Stage 1. Feasibility - Open label stage:
Up to fourteen patients will be enrolled in this stage and receive a CBD enema formulation for 12 weeks treatment period.
If results of this stage prove to be safe and with clinical effect (reduction of 3 points in full Mayo score in at least 50% of patients), the study will proceed to stage 2.
Stage 2. Randomized, placebo controlled blinded stage:
Subjects will be randomized in a 2:1 ratio and receive the drug/placebo enema for a 12 weeks treatment period.
Patients will be assessed for full Mayo score on visit 1 and week 12, and partial Mayo score every visit. Patients will assessed by a clinician using the self reported outcome (PRO) scale every visit. Sigmoidoscopy will be performed at baseline and week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IcBD-01 | Experimental | Drug: CBD, synthetic formIcBD-01 is a novel Cannabidiol enema formulation |
| placebo | Placebo comparator | Drug: Placeboplacebo enema formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years
- Diagnosis of UC at least 3 months prior to the Screening Visit
- Patients who were not treated rectally for UC in the last 3 days.
- UC patients with active disease and being treated with stable doses of biologics (at least 2 months), and/or steroids (at least 1 months) and/or oral mesalazine (at least 2 months at stable dose (4 gr)) or non-treated patients)
- Full Mayo score ≥4 to < 9 (range: 0-12) prior to enrolment in the study
Key exclusion criteria (14 listed)
- Diagnosis of severe extensive pancolitis
- Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis
- Complete resection of the colon with the need of a pouch
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 4 weeks of screening
- Sexual transmitted diseases
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 |
|---|---|---|
| CBD, synthetic formCannabidiol enema | Drug | IcBD-01 |
| Placeboplacebo enema | Drug | placebo |
Primary outcome
Change from baseline in Full Mayo Score
Time frame: 12 weeks
The Mayo Score is used to assess the severity of ulcerative colitis and can range from 0-12, with higher scores indicating worse severity.
4 secondary outcomes
Change in Partial Mayo Score
Time frame: 12 weeks
Change in patient reported outcome (PRO-UC)
Time frame: 12 weeks
Change in endoscopic Mayo subscore in distal 15 cm of anus
Time frame: 12 weeks
Change in the length of the inflamed colon
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBD, synthetic form in people with Ulcerative Colitis, run by CannaMore Biotechs at 1 site in Israel.
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 10 inclusion and 14 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 9 Apr 2024. 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 Israel. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Full Mayo Score (time frame: 12 weeks). 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 9 Apr 2024.