Back to resultsA First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BEN2293 (0.25% or 1.0% w/w) or matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Males and females with mild to moderate AD (based on vIGA) free from other clinically significant illness or disease that may adversely affect the safety of the patient or the integrity of the study as determined by medical history, physical examination, safety laboratory and other assessments.
- History of AD for at least 6 months diagnosed by a dermatologist or GP.
- Previous or current successful treatment with topical corticosteroids.
- A vIGA score of 2 (mild) to 3 (moderate) at both Screening and Day -1.
Exclusion Criteria:
- Atopic dermatitis of such severity that the patient could not comply with the demands of the study and/or the patient is not a suitable candidate for a placebo controlled study, as per Investigator's discretion.
- Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IMP application sites.
- Patients who have AD lesions affecting >3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
- Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
- Patients who are excessively hirsute in areas of skin to be dosed with study ointment.
- Patients who are unwilling to stop hair removal by any means (including shaving, waxing or depilatory creams) to skin areas to be dosed with study ointment for 2 weeks prior to Day -1 and throughout the duration of the study.
- Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic, or renal disorder).
- The patient has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to Day 1.
Sites / Locations
- MAC Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dose Regimen Low Dose
Dose Regimen High Dose
Placebo
Arm Description
Low Dose Strength
High Dose Strength
Placebo
Outcomes
Primary Outcome Measures
Safety and tolerability assessed by means of incidence of adverse events, incidence of adverse events at the local application site, mean vital signs, mean 12-lead ECG parameters and mean safety laboratory results.
Parameters measured by prompted reporting of adverse events and scheduled safety assessments.
Secondary Outcome Measures
PK-Cmax
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
PK-Tmax
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
PK-T1/2
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
PK-AUC
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
PK- over a dosing interval (AUCт)
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
PK - Accumulation ratio
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients
Time to itch reduction
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Fraction of patients achieving itch reduction
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Change from baseline in the Numerical Rating Scale (NRS) for pruritus - Worst Itch over 24 hours
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Scale graded by 0 - no itch through to 10 - worst imaginable itch.
Change from baseline in the Numerical Rating Scale (NRS) for pruritus - Current Itch
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Scale graded by 0 - no itch through to 10 - worst imaginable itch.
Change from baseline in Eczema Area and Severity Index (EASI) score
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index is graded 0 - none, absent, 1 - mild, 2 - moderate and 3 - severe.
Number of patients achieving improvement in Eczema Area and Severity Index (EASI) score
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index is graded 0 - none, absent, 1 - mild, 2 - moderate and 3 - severe.
Change from baseline in BSA affected by AD in treated area(s)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Change from baseline in vIGA score
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Change from baseline in Patient Oriented Eczema Measure (POEM)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. 7 questions based on skin condition graded between 0 - no days to 4 - everyday, with a total score of 28 being the worse.
Change from baseline in Dermatology Life Quality Index (DLQI)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index graded from 0 - not at all to 3 - very much. The higher the score, the more quality of life is impaired.
Change from baseline in EQ5D score
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. System has questions based on Itch - Scratching Behaviour, Itch - Mood and Sleep and Itch - Interference. questions are graded from 1 - never to 5 - almost always (worse score).
Change from baseline in Insomnia Severity Index (ISI)
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. 7 questions based on quality of sleep, graded 0 - none to 4 - very severe. Total score of 28 being the worse.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04737304
Brief Title
A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis
Official Title
A First-in-Human, Double-Blind, Randomised, Vehicle Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients With Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
January 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BenevolentAI Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomised, adaptive design, double-blind, placebo-controlled, first-in-human, two-part study to investigate the safety, tolerability, PK and preliminary efficacy of multiple topical doses of BEN2293 in patients with mild to moderate AD.
Detailed Description
This Protocol will be adaptive and designed to enable knowledge gained from the previous cohort to be applied to subsequent cohorts. Changes made will be within the boundaries of the adaptive elements with clear control mechanisms and guidance for staying within these boundaries.
Part A is a randomised, double-blind, placebo-controlled, sequential group study to investigate ascending multiple topical doses of BEN2293 in patients with mild to moderate AD. Patients will participate in only one cohort.
Part B is a randomised, double-blind, placebo-controlled, parallel group study to investigate up to two dose regimens of topical doses of BEN2293 administered for a maximum of 28 days in patients with mild to moderate AD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Regimen Low Dose
Arm Type
Experimental
Arm Description
Low Dose Strength
Arm Title
Dose Regimen High Dose
Arm Type
Experimental
Arm Description
High Dose Strength
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
BEN2293 (0.25% or 1.0% w/w) or matching placebo
Other Intervention Name(s)
BEN2293
Intervention Description
BEN2293 and placebo will be administered as a topical ointment. Both ointments contain the same excipients; placebo ointment has been manufactured in the same way except for the addition of 0.25% and 1.0% (w/w) BEN2293.
Primary Outcome Measure Information:
Title
Safety and tolerability assessed by means of incidence of adverse events, incidence of adverse events at the local application site, mean vital signs, mean 12-lead ECG parameters and mean safety laboratory results.
Description
Parameters measured by prompted reporting of adverse events and scheduled safety assessments.
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
PK-Cmax
Description
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Time Frame
Up to 28 days
Title
PK-Tmax
Description
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Time Frame
Up to 28 days
Title
PK-T1/2
Description
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Time Frame
Up to 28 days
Title
PK-AUC
Description
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Time Frame
Up to 28 days
Title
PK- over a dosing interval (AUCт)
Description
The investigation of the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
Time Frame
Up to 28 days
Title
PK - Accumulation ratio
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients
Time Frame
Up to 28 days
Title
Time to itch reduction
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Time Frame
Up to 28 days
Title
Fraction of patients achieving itch reduction
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Time Frame
Up to 28 days
Title
Change from baseline in the Numerical Rating Scale (NRS) for pruritus - Worst Itch over 24 hours
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Scale graded by 0 - no itch through to 10 - worst imaginable itch.
Time Frame
Up to 28 days
Title
Change from baseline in the Numerical Rating Scale (NRS) for pruritus - Current Itch
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Scale graded by 0 - no itch through to 10 - worst imaginable itch.
Time Frame
Up to 28 days
Title
Change from baseline in Eczema Area and Severity Index (EASI) score
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index is graded 0 - none, absent, 1 - mild, 2 - moderate and 3 - severe.
Time Frame
Up to 28 days
Title
Number of patients achieving improvement in Eczema Area and Severity Index (EASI) score
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index is graded 0 - none, absent, 1 - mild, 2 - moderate and 3 - severe.
Time Frame
Up to 28 days
Title
Change from baseline in BSA affected by AD in treated area(s)
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Time Frame
Up to 28 days
Title
Change from baseline in vIGA score
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Time Frame
Up to 28 days
Title
Change from baseline in Patient Oriented Eczema Measure (POEM)
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. 7 questions based on skin condition graded between 0 - no days to 4 - everyday, with a total score of 28 being the worse.
Time Frame
Up to 28 days
Title
Change from baseline in Dermatology Life Quality Index (DLQI)
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. Index graded from 0 - not at all to 3 - very much. The higher the score, the more quality of life is impaired.
Time Frame
Up to 28 days
Title
Change from baseline in EQ5D score
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD.
Time Frame
Up to 28 days
Title
Change from baseline in Patient Reported Outcomes Measurement Information System (PROMIS)
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. System has questions based on Itch - Scratching Behaviour, Itch - Mood and Sleep and Itch - Interference. questions are graded from 1 - never to 5 - almost always (worse score).
Time Frame
Up to 28 days
Title
Change from baseline in Insomnia Severity Index (ISI)
Description
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients with mild to moderate AD. 7 questions based on quality of sleep, graded 0 - none to 4 - very severe. Total score of 28 being the worse.
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females with mild to moderate AD (based on vIGA) free from other clinically significant illness or disease that may adversely affect the safety of the patient or the integrity of the study as determined by medical history, physical examination, safety laboratory and other assessments.
History of AD for at least 6 months diagnosed by a dermatologist or GP.
Previous or current successful treatment with topical corticosteroids.
A vIGA score of 2 (mild) to 3 (moderate) at both Screening and Day -1 (Part A) and at Screening, Day-3 and Day 1 (Part B).
Exclusion Criteria:
Atopic dermatitis of such severity that the patient could not comply with the demands of the study and/or the patient is not a suitable candidate for a placebo controlled study, as per Investigator's discretion.
Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IMP application sites.
Patients who have AD lesions affecting >3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
Patients who are excessively hirsute in areas of skin to be dosed with study ointment.
Patients who are unwilling to stop hair removal by any means (including shaving, waxing or depilatory creams) to skin areas to be dosed with study ointment for 2 weeks prior to Day -1 and throughout the duration of the study.
Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic, or renal disorder).
The patient has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to Day 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Thompson, MBBS
Organizational Affiliation
MAC Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
MAC Clinical Research
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis
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