Epidermolysis Bullosa SimplexPhase 2NCT04908215
INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa
A Phase 2 study testing INM-755 (cannabinol) cream in people with Epidermolysis Bullosa Simplex and Epidermolysis Bullosa, Junctional, run by InMed Pharmaceuticals Inc. at 7 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epidermolysis Bullosa Simplex, Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica
- What is being tested?
- INM-755 (cannabinol) cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 28 Dec 2021to 19 Apr 2023
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years with documented diagnosis of any of the following types of inherited EB: Simplex, Junctional, Dystrophic, Kindler. Enrolment will be extended to patients ≥12 years old and <18 years old after positive opinion of a data monitoring committee after at least 4 adult patients have completed study.
- Presence of at least 1 pair of well-matched index areas. Up to 2 pairs of index areas (1 pair of non-wound and 1 pair of wound index areas) can be selected in each patient
- For non-wound itch index areas, both areas should:
- Have chronic itch with a score ≥40 mm on a 100 mm VAS
- Not exceed 20 percent of body surface area (BSA) or be less than 1 percent of BSA
- Be similar size, up to twice the area of the smaller index area
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- For wound index areas, both wounds should:
- Have a surface area ≥5 cm^2 and ≤50 cm^2 inclusive and be aged ≥3 weeks
- Be well matched for size (up to twice the area of the smaller index area) and age (both either ≥3 weeks to 3 months or >3 months)
- Female patients of childbearing potential or men whose sexual partners are women of childbearing potential (WOCBP) must use highly effective birth control
- WOCBP must have a negative urine pregnancy test result at baseline
- Must provide written consent (or assent for patients aged <18 years with parental/guardian consent)
Who cannot join
- EB index areas have evidence of infection
- Patient has a systemic infection or used systemic antibiotics for EB-related infections within 7 days
- Use of systemic corticosteroids within 30 days or of topical corticosteroids on chosen index areas within 14 days
- Immunosuppressive therapy or cytotoxic chemotherapy within 60 days
- Use of any high potency opioid within 30 days
- Use of cannabis, cannabis extracts, or any cannabinoid products for medical or recreational use by any route of administration within 2 weeks
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- Prior stem cell transplant or gene therapy for EB
- History of malignancy including basal cell and squamous cell carcinomas
- Arterial or venous disorder resulting in ulcerated wounds
- Uncontrolled diabetes mellitus
- Chronic pruritus primarily attributable to pathologies or conditions other than EB
- Blood transfusion to treat anemia within the past 3 months
- Use of any investigational drug within 30 days or 5 half-lives (whichever is longer)
- An underlying condition which places the patient at unacceptable risk
- Women who are pregnant, breastfeeding (lactating), or planning to become pregnant during the study
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
France2 sites
Hopital Saint Louis APHP Paris
Paris, 75010
CHU Toulouse - Hopital Larrey
Toulouse, 31059
Italy2 sites
Fondazione IRCCS Ca Granda. Ospedale Maggiore Policlinico
Milan, Milano, 20122
Instituto Dermopatico dell'Immacolata, IDI-IRCCS
Rome, Roma, 00167
Greece1 site
Andreas Syggros Hospital of Cutaneous Venereal Diseases
Athens, 16121
About this study
Official title: A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (Cannabinol) Cream in Patients With Epidermolysis Bullosa
The purpose of this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB).
Read the detailed description
This is an international, multicenter study to evaluate the safety and obtain preliminary evidence of efficacy of topically applied INM-755 (cannabinol) cream in up to 20 patients with inherited EB (Simplex, Dystrophic, Junctional, or Kindler). The study uses a within-patient, double-blind design in which matched index areas are randomized to INM-755 (cannabinol) cream or vehicle cream as a control.
Selected index areas may be wounds or non-wound areas. Randomized treatments are applied daily to non-wound areas and every 1, 2, or 3 days on wounds, according to the patient's schedule for dressing changes. Treatment is over a 28-day period. EB symptoms are evaluated based on patient-reported outcomes. Wound healing is measured by digital photography. In this study designed to obtain preliminary evidence of efficacy, there is no single primary efficacy endpoint. Efficacy endpoints vary according to the presenting symptoms in each patient, which may include the presence of open wounds, wound pain associated with dressing changes, background wound pain (not procedurally linked), wound itch, and itch in non-wound areas. Net benefit from INM-755 cream is evaluated within each patient and based on their clinical needs at baseline.
Enrollment is beginning with adults and may be expanded to include adolescents.
- Conditions
- Epidermolysis Bullosa Simplex, Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica, Kindler Syndrome
- Being tested
- INM-755 (cannabinol) cream, Vehicle Cream
- Medical subject headings
- Epidermolysis Bullosa Simplex, Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica, Poikiloderma of Kindler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INM-755 (cannabinol) creamDrug
topical cream containing cannabinol for dermal application
Vehicle CreamDrug
topical cream base for dermal application containing no active agent
| Study group | Role | What they receive |
|---|---|---|
| INM-755 (cannabinol) cream | Experimental | Cannabinol cream, topically applied daily in thin layer on non-wound index areas and every 1, 2 or 3 days in thick layer on dressings for index wounds for a 28-day period. Receives: Drug: INM-755 (cannabinol) cream |
| Vehicle cream | Placebo comparator | Vehicle cream, topically applied daily in thin layer on non-wound index areas and every 1, 2 or 3 days in thick layer on dressings for index wounds for a 28-day period. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Non-Wound Itch by Visual Analogue Scale (VAS)
Patients will report peak (maximal) pruritus intensity over the previous 24 hours using a 100 mm VAS (0 being "no itch" to 100 mm being "worst imaginable itch") recorded daily in the study diary. This outcome measure is applicable only for patients with non-wound index areas with eligible (moderate to severe) itch.
Measured: Baseline to Day 29
Change from Baseline in Wound Surface Area
Wound surface area will be measured by digital photography at weekly intervals. This outcome measure is applicable only for patients with wound index areas.
Measured: Baseline to Day 29
Change from Baseline in Procedural Wound Pain by VAS
Patients will report wound pain intensity using a 100 mm VAS (0 being "no pain" to 100 mm being "worst imaginable pain") and this will be recorded in the study diary. Procedural pain will be assessed immediately after each wound dressing, which may be every 1, 2, or 3 days according to an individual patient's schedule for dressing change. This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) procedural pain.
Measured: Baseline to Day 29
Change from Baseline in Background Wound Pain by VAS
Patients will report wound pain intensity using a 100 mm VAS (0 being "no pain" to 100 mm being "worst imaginable pain") and this will be recorded in the study diary. Peak (maximal) background pain will be assessed daily in the morning (done before the dressing change). This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) background pain.
Measured: Baseline to Day 29
Change from Baseline in Wound Itch by VAS
Patients will report peak (maximal) pruritus intensity over the previous 24 hours using a 100 mm VAS (0 being "no itch" to 100 mm being "worst imaginable itch") recorded daily in the study diary. This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) itch.
Measured: Baseline to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start28 Dec 2021
- Primary completion3 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa SimplexStudies 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
- Model description
- Within-patient randomized, double-blind comparisons of INM-755 (cannabinol cream) versus vehicle cream (control) in matched, paired index areas
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMed Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandra DJ Mancini, MSc, Study director, InMed Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908215
- Sponsor's protocol ID
- 755-201-EB
- Status last verified
- Jun 2023
- First submitted
- 26 May 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (Cannabinol) Cream in Patients With Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT04908215
- Acronym / sponsor ID
- 755-201-EB
- Conditions
- Epidermolysis Bullosa Simplex, Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica, Kindler Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- InMed Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 1 Jun 2021 (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 this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB).
Detailed description
This is an international, multicenter study to evaluate the safety and obtain preliminary evidence of efficacy of topically applied INM-755 (cannabinol) cream in up to 20 patients with inherited EB (Simplex, Dystrophic, Junctional, or Kindler). The study uses a within-patient, double-blind design in which matched index areas are randomized to INM-755 (cannabinol) cream or vehicle cream as a control.
Selected index areas may be wounds or non-wound areas. Randomized treatments are applied daily to non-wound areas and every 1, 2, or 3 days on wounds, according to the patient's schedule for dressing changes. Treatment is over a 28-day period. EB symptoms are evaluated based on patient-reported outcomes. Wound healing is measured by digital photography. In this study designed to obtain preliminary evidence of efficacy, there is no single primary efficacy endpoint. Efficacy endpoints vary according to the presenting symptoms in each patient, which may include the presence of open wounds, wound pain associated with dressing changes, background wound pain (not procedurally linked), wound itch, and itch in non-wound areas. Net benefit from INM-755 cream is evaluated within each patient and based on their clinical needs at baseline.
Enrollment is beginning with adults and may be expanded to include adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-patient randomized, double-blind comparisons of INM-755 (cannabinol cream) versus vehicle cream (control) in matched, paired index areas
| Arm | Type | Receives |
|---|---|---|
| INM-755 (cannabinol) cream | Experimental | Drug: INM-755 (cannabinol) creamCannabinol cream, topically applied daily in thin layer on non-wound index areas and every 1, 2 or 3 days in thick layer on dressings for index wounds for a 28-day period. |
| Vehicle cream | Placebo comparator | Drug: Vehicle CreamVehicle cream, topically applied daily in thin layer on non-wound index areas and every 1, 2 or 3 days in thick layer on dressings for index wounds for a 28-day period. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients aged ≥18 years with documented diagnosis of any of the following types of inherited EB: Simplex, Junctional, Dystrophic, Kindler. Enrolment will be extended to patients ≥12 years old and <18 years old after positive opinion of a data monitoring committee after at least 4 adult patients have completed study.
- Presence of at least 1 pair of well-matched index areas. Up to 2 pairs of index areas (1 pair of non-wound and 1 pair of wound index areas) can be selected in each patient
- For non-wound itch index areas, both areas should:
- For wound index areas, both wounds should:
- Female patients of childbearing potential or men whose sexual partners are women of childbearing potential (WOCBP) must use highly effective birth control
Key exclusion criteria (15 listed)
- EB index areas have evidence of infection
- Patient has a systemic infection or used systemic antibiotics for EB-related infections within 7 days
- Use of systemic corticosteroids within 30 days or of topical corticosteroids on chosen index areas within 14 days
- Immunosuppressive therapy or cytotoxic chemotherapy within 60 days
- Use of any high potency opioid within 30 days
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 |
|---|---|---|
| INM-755 (cannabinol) creamtopical cream containing cannabinol for dermal application | Drug | INM-755 (cannabinol) cream |
| Vehicle Creamtopical cream base for dermal application containing no active agent | Drug | Vehicle cream |
Primary outcome
Change from Baseline in Non-Wound Itch by Visual Analogue Scale (VAS)
Time frame: Baseline to Day 29
Patients will report peak (maximal) pruritus intensity over the previous 24 hours using a 100 mm VAS (0 being "no itch" to 100 mm being "worst imaginable itch") recorded daily in the study diary. This outcome measure is applicable only for patients with non-wound index areas with eligible (moderate to severe) itch.
Change from Baseline in Wound Surface Area
Time frame: Baseline to Day 29
Wound surface area will be measured by digital photography at weekly intervals. This outcome measure is applicable only for patients with wound index areas.
Change from Baseline in Procedural Wound Pain by VAS
Time frame: Baseline to Day 29
Patients will report wound pain intensity using a 100 mm VAS (0 being "no pain" to 100 mm being "worst imaginable pain") and this will be recorded in the study diary. Procedural pain will be assessed immediately after each wound dressing, which may be every 1, 2, or 3 days according to an individual patient's schedule for dressing change. This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) procedural pain.
Change from Baseline in Background Wound Pain by VAS
Time frame: Baseline to Day 29
Patients will report wound pain intensity using a 100 mm VAS (0 being "no pain" to 100 mm being "worst imaginable pain") and this will be recorded in the study diary. Peak (maximal) background pain will be assessed daily in the morning (done before the dressing change). This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) background pain.
Change from Baseline in Wound Itch by VAS
Time frame: Baseline to Day 29
Patients will report peak (maximal) pruritus intensity over the previous 24 hours using a 100 mm VAS (0 being "no itch" to 100 mm being "worst imaginable itch") recorded daily in the study diary. This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) itch.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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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.
Alexandra DJ Mancini, MSc study director
InMed Pharmaceuticals Inc.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INM-755 (cannabinol) cream in people with Epidermolysis Bullosa Simplex and Epidermolysis Bullosa, Junctional, run by InMed Pharmaceuticals Inc. at 7 sites in 5 countries.
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 12 inclusion and 15 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: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Italy, Germany, Greece, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Non-Wound Itch by Visual Analogue Scale (VAS) (time frame: Baseline to Day 29). 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 3 Jul 2023.