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

BenevolentAI Bio123 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

123

Conditions

Atopic Dermatitis

Interventions

BEN2293 (0.25% or 1.0% w/w) or matching placeboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

MAC Clinical Research

Manchester, United Kingdom

Outcomes

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