CompletedNCT04737304Updated Jun 18, 2023

A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis

A Phase 1/2 interventional study of BEN2293 (0.25% or 1.0% w/w) or matching placebo in Atopic Dermatitis, sponsored by BenevolentAI Bio. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by BenevolentAI Bio · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 123
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Atopic Dermatitis

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Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 123 participants (actual)

Study arms

Experimental
Dose Regimen Low Dose
Low Dose Strength
Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo
Experimental
Dose Regimen High Dose
High Dose Strength
Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo
Placebo comparator
Placebo
Placebo
Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo

Interventions

DrugBEN2293 (0.25% or 1.0% w/w) or matching placebo
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.
Also known as: BEN2293

What researchers measure

Primary outcomes

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.
Time frame: Up to 28 days

Secondary outcomes

PK-Cmax
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
PK-Tmax
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
PK-T1/2
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
PK-AUC
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
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.
Time frame: Up to 28 days
PK - Accumulation ratio
The investigation of the effect of BEN2293 on pruritus and Atopic Dermatitis in patients
Time frame: Up to 28 days
Time to itch reduction
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
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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.
Time frame: Up to 28 days
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).
Time frame: Up to 28 days
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.
Time frame: Up to 28 days

Study locations

1 site

MAC Clinical Research
Manchester, M13 9NQ, United Kingdom

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT04737304
Lead sponsor: BenevolentAI Bio
Responsible party: Sponsor
First posted: Feb 3, 2021
Start date: Oct 14, 2020
Primary completion: Jan 12, 2023
Completion: Jan 26, 2023
Last update: Jun 18, 2023

Study contacts

Alexander Thompson, MBBS

principal investigator · MAC Clinical Research

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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