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

NCT04737304 | Completed Phase 1

• 1 other identifier: BB-2293-101b
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 28 days

Secondary Outcomes (19)

• PK-Cmax

  Up to 28 days

• PK-Tmax

  Up to 28 days

• PK-T1/2

  Up to 28 days

• PK-AUC

  Up to 28 days

• PK- over a dosing interval (AUCт)

  Up to 28 days

Study Arms (3)

Dose Regimen Low Dose

EXPERIMENTAL

Low Dose Strength

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

Dose Regimen High Dose

EXPERIMENTAL

High Dose Strength

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

Placebo

PLACEBO COMPARATOR

Placebo

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

Interventions

BEN2293 (0.25% or 1.0% w/w) or matching placebo DRUG

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

Dose Regimen High Dose; Dose Regimen Low Dose; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• BenevolentAI Bio: lead

Study Sites (1)

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alexander Thompson, MBBS

  MAC Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: February 3, 2021
• Study Start: October 14, 2020
• Primary Completion: January 12, 2023
• Study Completion: January 26, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)