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

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Status and phase: Completed; Phase 2; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04737304

BB-2293-101b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 3 patient groups, including a placebo group

Dose Regimen Low Dose

Experimental group

Description:

Low Dose Strength

Treatment:

Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo

Dose Regimen High Dose

Experimental group

Description:

High Dose Strength

Treatment:

Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: BEN2293 (0.25% or 1.0% w/w) or matching placebo