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Clinical Trial Results:
A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.

Summary
EudraCT number	2021-000214-42
Trial protocol	DE FR AT GR IT ES
Global end of trial date	19 Apr 2023

Results information
Results version number	v1(current)
This version publication date	13 Apr 2024
First version publication date	13 Apr 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

755-201-EB

ISRCTN number

US NCT number

NCT04908215

WHO universal trial number (UTN)

Sponsor organisation name

InMed Pharmaceuticals Inc.

Sponsor organisation address

Suite 310 - 815 West Hastings Street, Vancouver, Canada, V6C 1B4

Public contact

Clinical Research Executive, InMed Pharmaceuticals Inc., 1 604-669-7207, clinical@inmedpharma.com

Scientific contact

Clinical Research Executive, InMed Pharmaceuticals Inc., 1 604-669-7207, clinical@inmedpharma.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

19 Apr 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

19 Apr 2023

Global end of trial reached?

Yes

Global end of trial date

19 Apr 2023

Was the trial ended prematurely?

Main objective of the trial

- To evaluate the safety of INM-755 cream in patients with EB. - To obtain preliminary evidence of efficacy of INM-755 cream on wound and non-wound affected skin areas in patients with EB.

Protection of trial subjects

No special measures were required for this Phase 2 study of a topical cream product. If an important adverse reaction to the cream were to occur, it would simply be washed off and/or not re-applied in accordance with normal investigator oversight and patient preference.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Dec 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 3

Country: Number of subjects enrolled

Greece: 5

Country: Number of subjects enrolled

Italy: 4

Country: Number of subjects enrolled

Israel: 2

Country: Number of subjects enrolled

France: 5

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Recruitment of patients for this very rare disease was undertaken in 6 EU countries (Austria, France, Germany, Greece, Italy, and Spain) and Israel. No patients were enrolled in Austria or Spain. The first patient was screened on 15Dec2021 in Israel and enrolled (first treatment) on 28Dec2021. The last patient was enrolled 10Mar2023.

Screening details

Overall 27 subjects were screened: 4 subjects were screen failures immediately, 4 were SFs at the end of baseline observation week. A total of 19 patients were enrolled and received INM-755 cream and Vehicle cream. This study used a within-patient randomisation of pairs of matched index areas (1 area to INM-755 therapy and 1 area to Vehicle cream).

Period 1 title

Treatment Period (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Assessor

Blinding implementation details

Each patient could have a matched pair of non-wound index areas, wound index areas, or both. Each index area in a matched pair was randomised to INM-755 cream or Vehicle cream in a 1:1 ratio in a blinded manner. Study creams were identical in appearance and labelled in a blinded way. No study site personnel, patient, Sponsor personnel, or Sponsor designee who was involved in study conduct decisions was unblinded to treatment assignment throughout the duration of the study.

Are arms mutually exclusive

Non-Wound INM-755

Arm description

Non-wound index area within a matched pair assigned to INM-755 treatment

Arm type

Experimental

Investigational medicinal product name

INM-755 (cannabinol) Cream

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Cutaneous use, Topical

Dosage and administration details

For non-wound index areas, the application of the study drug (either INM-755 cream or Vehicle cream) was done once daily, applied by the patient or caregiver directly on the index area skin in a typical thin layer (approximately 2 mg cream per cm2 of skin) and gently rubbed into the skin. Patients were given practical instructions on how to measure a suitable amount of cream using Fingertip Units calculated for the size of the area being treated. No dressing was required, but it was optional per the patient's preference. Treatment was to be given for a maximum of 28 days (Days 1 to 28).

Non-Wound Vehicle

Arm description

Non-wound index area within a matched pair assigned to Vehicle control treatment

Arm type

vehicle control

Investigational medicinal product name

Vehicle Cream

Investigational medicinal product code

Other name

Pharmaceutical forms

Cream

Routes of administration

Cutaneous use, Topical

Dosage and administration details

Number of subjects in period 1	Non-Wound INM-755	Non-Wound Vehicle
Started	18	18
Week 1	18	18
Week 2	18	18
Week 3	18	18
Week 4	17	17
Completed	17	17
Not completed	1	1
Adverse event, non-fatal	1	1

Baseline characteristics

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Reporting group title

Treatment Period

Reporting group description

19 patients were enrolled and treated. Each patient had at least one pair of matched index areas treated with INM-755 and Vehicle in a randomized blinded manner. 17 patients had 1 pair of matched non-wound (NW) Index areas. 1 patient had 1 pair of matched wound (W) Index areas. 1 patient had both 1 pair of NW index areas and 1 pair of W index areas. N=18 patients for NW index areas, N=2 for W index areas.

Reporting group values	Treatment Period	Total
Number of subjects	19	19
Age categorical
Units: Subjects
Adolescents (12-17 years)	3	3
Adults (18-64 years)	15	15
From 65-84 years	1	1
Age continuous
Units: years
arithmetic mean (standard deviation)	35.3 ± 15.39	-
Gender categorical
Units: Subjects
Female	11	11
Male	8	8
Race
Units: Subjects
White	19	19
Ethnicity
Units: Subjects
Hispanic or Latino	0	0
Not Hispanic or Latino	16	16
Unknown/Not Reported	3	3
Fitzpatrick Skin Type
Skin Type scale based on skin colour and sensitivity to sun
Units: Subjects
Fitzpatrick Skin Type I	2	2
Fitzpatrick Skin Type II	6	6
Fitzpatrick Skin Type III	10	10
Fitzpatrick Skin Type IV	1	1
Fitzpatrick Skin Type V	0	0
Fitzpatrick Skin Type VI	0	0
Epidermolysis bullosa (EB) Type
Genetic subtype of epidermolysis bullosa
Units: Subjects
EB Simplex	4	4
EB Junctional	2	2
EB Dominant Dystrophic	2	2
EB Recessive Dystrophic	9	9
EB Kindler	2	2

Subject analysis set title

Safety Analysis Set (SAF)

Subject analysis set type

Safety analysis

Subject analysis set description

The SAF consisted of all index areas (non-wound or wound) that received INM-755 cream or matching Vehicle cream. The SAF was used for safety summaries and analysis of local effects. All patients who received the study drug were assessed for systemic effects. A total of 19 patients were enrolled and treated; 18 patients had non-wound index pairs and 2 patients had wound index pairs. One of the 19 patients had both non-wound and wound index pairs. Within each index pair, one skin area was randomized to INM-755 and one was randomized to Vehicle, in a blinded manner.

Subject analysis set title

Pharmacokinetic Analysis Set (PKS)

Subject analysis set type

Safety analysis

Subject analysis set description

The PKS included all patients who received at least one dose of the study drug and had at least one PK concentration measured. Provision of a single blood sample at the end of treatment for measurement of plasma cannabinol concentration was optional and 14 patients consented for that procedure.

Subject analysis set title

Non-wound Itch Evaluable Analysis Set (ESA)

Subject analysis set type

Per protocol

Subject analysis set description

All non-wound index areas meeting the eligibility criterion of non-wound itch ≥40 mm on Visual Analogue Scale (VAS, 0-100 mm) during the Baseline Observation Period (1 week before randomization and treatment initiation). *If a randomisation error was detected after database lock (once unblinding had occurred) then the SAF analysis set was to be used, in order to consider the effect of the actual treatment. This is what was done. It was an analysis "as treated".

Subject analysis sets values	Safety Analysis Set (SAF)	Pharmacokinetic Analysis Set (PKS)	Non-wound Itch Evaluable Analysis Set (ESA)
Number of subjects	19	14	14
Age categorical
Units: Subjects
Adolescents (12-17 years)	3	0	2
Adults (18-64 years)	15	13	11
From 65-84 years	1	1	1
Age continuous
Units: years
arithmetic mean (standard deviation)	±	±	±
Gender categorical
Units: Subjects
Female	11	6	9
Male	8	8	5
Race
Units: Subjects
White	19	14	14
Ethnicity
Units: Subjects
Hispanic or Latino	0	0	0
Not Hispanic or Latino	16	11	13
Unknown/Not Reported	3	3	1
Fitzpatrick Skin Type
Skin Type scale based on skin colour and sensitivity to sun
Units: Subjects
Fitzpatrick Skin Type I	2	1	2
Fitzpatrick Skin Type II	6	5	3
Fitzpatrick Skin Type III	10	7	8
Fitzpatrick Skin Type IV	1	1	1
Fitzpatrick Skin Type V	0	0	0
Fitzpatrick Skin Type VI	0	0	0
Epidermolysis bullosa (EB) Type
Genetic subtype of epidermolysis bullosa
Units: Subjects
EB Simplex	4	2	3
EB Junctional	2	2	0
EB Dominant Dystrophic	2	2	2
EB Recessive Dystrophic	9	6	7
EB Kindler	2	2	2

End points

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Reporting group title

Non-Wound INM-755

Reporting group description

Non-wound index area within a matched pair assigned to INM-755 treatment

Reporting group title

Non-Wound Vehicle

Reporting group description

Non-wound index area within a matched pair assigned to Vehicle control treatment

Subject analysis set title

Safety Analysis Set (SAF)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Pharmacokinetic Analysis Set (PKS)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Non-wound Itch Evaluable Analysis Set (ESA)

Subject analysis set type

Per protocol

Subject analysis set description

Primary: NW Itch: Within-patient difference in CFB (INM-755 - Vehicle)

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End point title

NW Itch: Within-patient difference in CFB (INM-755 - Vehicle)

End point description

Patients scored itch once daily for each non-wound (NW) index area within a matched pair (one area received INM-755, the other received Vehicle, as randomized and blinded). Itch was scored on the Visual Analogue Scale (0-100 mm), with 0 score meaning no itch and 100 score meaning the worst imaginable itch. Average weekly Itch scores were calculated for each index area and within-patient comparisons of INM-755 and Vehicle were tested using paired t-tests of the Change from Baseline (CFB). Note for interpretation: A negative value for within-patient difference in CFB (INM-755 - Vehicle) would favour INM-755.

End point type

Primary

End point timeframe

Weekly for 4 weeks

End point values	Non-Wound INM-755	Non-Wound Vehicle	Non-wound Itch Evaluable Analysis Set (ESA)
Number of subjects analysed	14 ^[1]	14 ^[2]	14 ^[3]
Units: mm
arithmetic mean (standard deviation)
Week 1	-19.224 ± 27.2640	-17.786 ± 18.9561	-1.439 ± 15.8467
Week 2	-19.306 ± 27.3566	-20.194 ± 24.9994	0.888 ± 7.6389
Week 3	-23.19 ± 23.9680	-23.614 ± 24.8766	0.424 ± 15.6356
Week 4	-32.021 ± 26.6676	-29.867 ± 26.8017	-2.155 ± 14.3983

Notes
[1] - NW index areas excluded from ESA for 4 pts; 1 patient missing Week 4
[2] - NW index areas excluded from ESA for 4 pts; 1 patient missing Week 4
[3] - The within-patient difference in CFB for matched index areas (INM-755 - Vehicle). 1 missing Wk 4.

NW Itch: Within-patient Paired t-test, Week 4

Statistical analysis description

Average weekly Itch scores were calculated for each index area and within-patient comparisons of INM-755 and Vehicle were tested using paired t-tests of the Change from Baseline (CFB). A negative value for within-patient difference in CFB (INM-755 - Vehicle) favours INM-755.

Comparison groups

Non-Wound INM-755 v Non-Wound Vehicle

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5994 ^[4]

Method

paired t-test

Parameter type

Mean difference (final values)

Point estimate

-2.155

Confidence interval

level

95%

sides

2-sided

lower limit

-10.8554

upper limit

6.5462

Variability estimate

Standard deviation

Dispersion value

14.3983

Notes
[4] - p-values at earlier timepoints: Week 1 = 0.7395 Week 2 = 0.6708 Week 3 = 0.9206

Secondary: PIC-I: Within-patient difference in CFB (INM-755 - Vehicle)

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End point title

PIC-I: Within-patient difference in CFB (INM-755 - Vehicle)

End point description

PIC-I = Patient's Impression of Change for Non-wound Itch. This was reported by the patient after 2 and 4 weeks of treatment for each of the matched index areas (one treated with INM-755, one with Vehicle). They scored their impression of change from baseline, using the Dynamic Pruritus Scale (+50 mm for maximal improvement (almost no itch remaining) to -50 mm (maximal worsening of itch), with 0 mm for no change. Note for interpretation: A positive result for within patient difference (PIC-I INM-755 minus PIC-I Vehicle) would indicate a better outcome on itch for INM-755 compared with Vehicle on the basis of PIC-I.

End point type

Secondary

End point timeframe

Week 2 and Week 4

End point values	Non-Wound INM-755	Non-Wound Vehicle	Non-wound Itch Evaluable Analysis Set (ESA)
Number of subjects analysed	14 ^[5]	14 ^[6]	14 ^[7]
Units: mm
arithmetic mean (standard deviation)
Week 2	9.7 ± 24.85	12.6 ± 29.22	-2.9 ± 12.64
Week 4	10.0 ± 28.00	7.5 ± 31.68	2.5 ± 14.07

Notes
[5] - 4 pts excluded from ESA. Missing data for 1 pt at Week 2 (n=13). At Week 4 n=14.
[6] - 4 pts excluded from ESA. Missing data for 1 pt at Week 2 (n=13). At Week 4 n=14.
[7] - Missing data for 1 pt at Week 2 (n=13). At Week 4 n=14.

PIC-I CFB: Within-patient Paired t-test, Week 4

Comparison groups

Non-Wound INM-755 v Non-Wound Vehicle

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5178 ^[8]

Method

paired t-test

Parameter type

Mean difference (final values)

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-5.62

upper limit

10.62

Variability estimate

Standard deviation

Dispersion value

14.07

Notes
[8] - p-value at Week 2 = 0.4206

Other pre-specified: Plasma Cannabinol Concentration, End of Study

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End point title

Plasma Cannabinol Concentration, End of Study

End point description

It was optional for patients to provide a single blood sample for analysis at the end of treatment. 14 patients consented to this. Most samples were drawn within 0-2 days after last dose. For 3 patients, the samples were at 5, 7, and 19 days after last dose. Limit of quantitation was 1.0 pg/mL.

End point type

Other pre-specified

End point timeframe

Week 4 (End of Study)

End point values	Pharmacokinetic Analysis Set (PKS)
Number of subjects analysed	14
Units: pg/mL
median (full range (min-max))	4.850 (0.00 to 176.00)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Entire treatment period: From first dose of study treatment until completion of therapy (max 4 weeks), and 1 week additional safety follow-up.

Adverse event reporting additional description

AEs were collected at weekly visits and recorded as local or systemic. Local AEs in index areas: treatment-emergent (TE) local AEs were summarised by treatment, severity, association with treatment or dressings. Other Local AEs (in untreated areas). Systemic AEs: TE systemic AEs were summarised by severity, association with treatment

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

INM-755 Treated Non-wound Index Areas, Local AEs

Reporting group description

This is the group of NW Index Areas treated with INM-755. Each patient with matched pairs of NW Index Areas received both treatments, one area treated with INM-755, the other with Vehicle (randomised, blinded).

Reporting group title

INM-755 Treated Wound Index Areas, Local AEs

Reporting group description

This is the group of Wound Index Areas treated with INM-755. Each patient with matched pairs of Wound Index Areas received both treatments, one area treated with INM-755, the other with Vehicle (randomised, blinded).

Reporting group title

Vehicle Treated Non-wound Index Areas, Local AEs

Reporting group description

This is the group of NW Index Areas treated with Vehicle. Each patient with matched pairs of NW Index Areas received both treatments, one area treated with INM-755, the other with Vehicle (randomised, blinded).

Reporting group title

Vehicle Treated Wound Index Areas, Local AEs

Reporting group description

This is the group of Wound Index Areas treated with Vehicle. Each patient with matched pairs of Wound Index Areas received both treatments, one area treated with INM-755, the other with Vehicle (randomised, blinded).

Reporting group title

Untreated Areas, Local AEs

Reporting group description

AEs were categorized as local or systemic. These local areas were not treated. The underlying disease (epidermolysis bullosa) is characterized by many skin lesions.

Reporting group title

All Treated Patients, Systemic AEs

Reporting group description

All patients received both INM-755 and Vehicle as topical treatments on matched index area pairs. These are the systemic AEs reported, not the AEs that occurred locally at the treated index areas or in other local untreated areas.

Serious adverse events	INM-755 Treated Non-wound Index Areas, Local AEs	INM-755 Treated Wound Index Areas, Local AEs	Vehicle Treated Non-wound Index Areas, Local AEs	Vehicle Treated Wound Index Areas, Local AEs	Untreated Areas, Local AEs	All Treated Patients, Systemic AEs
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Infections and infestations
Endocarditis
Additional description: Endocarditis after 3 weeks of treatment, assessed as not related to masked study treatment. In the opinion of the Investigator, the event was due to the underlying medical condition of cardiomyopathy. Hospitalised, study treatment interrupted.
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	INM-755 Treated Non-wound Index Areas, Local AEs	INM-755 Treated Wound Index Areas, Local AEs	Vehicle Treated Non-wound Index Areas, Local AEs	Vehicle Treated Wound Index Areas, Local AEs	Untreated Areas, Local AEs	All Treated Patients, Systemic AEs
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 18 (16.67%)	0 / 2 (0.00%)	2 / 18 (11.11%)	0 / 2 (0.00%)	3 / 19 (15.79%)	7 / 19 (36.84%)
Vascular disorders
Hypertension
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	1
Nervous system disorders
Headache
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	4
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	1
Gastrointestinal disorders
Anal fissure
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	1
Toothache
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	1
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	2 / 19 (10.53%)
occurrences all number	0	0	0	0	0	2
Skin and subcutaneous tissue disorders
Blister
subjects affected / exposed	1 / 18 (5.56%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	1	0	0	0	1	0
Eczema asteatotic
subjects affected / exposed	1 / 18 (5.56%)	0 / 2 (0.00%)	1 / 18 (5.56%)	0 / 2 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	1	0	1	0	0	0
Erythema
subjects affected / exposed	1 / 18 (5.56%)	0 / 2 (0.00%)	1 / 18 (5.56%)	0 / 2 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	1	0	1	0	0	0
Pruritus
subjects affected / exposed	2 / 18 (11.11%)	0 / 2 (0.00%)	1 / 18 (5.56%)	0 / 2 (0.00%)	0 / 19 (0.00%)	0 / 19 (0.00%)
occurrences all number	2	0	1	0	0	0
Pseudofolliculitis
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	1	0
Skin ulcer
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	1 / 19 (5.26%)	0 / 19 (0.00%)
occurrences all number	0	0	0	0	1	0
Infections and infestations
Endocarditis
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	1
Nasopharyngitis
subjects affected / exposed	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 18 (0.00%)	0 / 2 (0.00%)	0 / 19 (0.00%)	1 / 19 (5.26%)
occurrences all number	0	0	0	0	0	1

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: NW Itch: Within-patient difference in CFB (INM-755 - Vehicle)

Primary: NW Itch: Within-patient difference in CFB (INM-755 - Vehicle)

Secondary: PIC-I: Within-patient difference in CFB (INM-755 - Vehicle)

Secondary: PIC-I: Within-patient difference in CFB (INM-755 - Vehicle)

Other pre-specified: Plasma Cannabinol Concentration, End of Study

Other pre-specified: Plasma Cannabinol Concentration, End of Study

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: NW Itch: Within-patient difference in CFB (INM-755 - Vehicle)

Primary: NW Itch: Within-patient difference in CFB (INM-755 - Vehicle)

Secondary: PIC-I: Within-patient difference in CFB (INM-755 - Vehicle)

Secondary: PIC-I: Within-patient difference in CFB (INM-755 - Vehicle)

Other pre-specified: Plasma Cannabinol Concentration, End of Study

Other pre-specified: Plasma Cannabinol Concentration, End of Study

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.