A Clinical Trial of BMX-010 in Adult Subjects With Atopic Dermatitis

NCT05491447 | Terminated Phase 2 FDA Drug

• 1 other identifier: BMX-DERM-02
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 19

Brief Summary

Phase 2 clinical trial conducted in 2 parts: Part 1 - Pharmacokinetics and Part 2 - Randomized and Placebo Controlled (subject and clinical assessors will be blinded). Study Product will be applied to AD BID days 1-28. There will be weekly visits from Baseline (day 1) through Day 29. There is a final follow up visit 2 weeks after.

Conditions

Atopic Dermatitis

Keywords

AD

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Eczema Area and Severity Index at Week 4

  Evaluate the change in Eczema Area and Severity Index score in subjects with active AD treating with BMX-010 0.5% and 0.1% ointment compared with vehicle from baseline to week 4.

  28 days

• Incidence of treatment emergent adverse events and changes from baseline in vital signs and clinical laboratory parameters

  Compare treatment emergent adverse events, as well as changes from baseline in vital signs and clinical laboratory parameters in subjects with active AD receiving BMX-010 0.5% and 0.1% ointment compared with vehicle.

  28 days

Secondary Outcomes (9)

• Change from baseline in Eczema Area and Severity Index at weeks 1, 2, and 3.

  21 days

• Proportion of subjects who achieve Eczema Area and Severity Index-50 and Eczema Area and Severity Index -75 at Weeks 1, 2, 3 and 4.

  28 days

• Change from baseline in Body Surface Area x validated Investigator Global Assessment of Atopic Dermatitis scoreat Weeks 1, 2, 3, and 4

  28 days

• Change from baseline in body surface area at Weeks 1, 2, 3, and 4.

  28 days

• Change from baseline in validated Investigator Global Assessment of Atopic Dermatitis at Weeks 1, 2, 3, and 4.

  28 days

Other Outcomes (2)

• Change and percent change from baseline of subject-reported Patient-Oriented Eczema Measure (POEM) scores to Week 4.

  28 days

• Change from baseline in answers on the subject reported PRO questions regarding itching at Weeks 1, 2, 3 and 4

  28 days

Study Arms (3)

Study Drug Treated, BMX-010 0.5%

ACTIVE COMPARATOR

n=72

Drug: BMX-010

Study Drug Treated, BMX-010 0.1%

ACTIVE COMPARATOR

n=72

Drug: BMX-010

Placebo Treated

PLACEBO COMPARATOR

n=72

Drug: Placebo

Interventions

BMX-010 DRUG

Ointment

Study Drug Treated, BMX-010 0.1%; Study Drug Treated, BMX-010 0.5%

Placebo DRUG

Ointment

Placebo Treated

Eligibility Criteria

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

You may qualify if:

• Male or female, at least 18 years of age at the time of consent;
• Diagnosis of AD, as defined by the criteria of Hanifin and Rajka, stable in the last 4 weeks, with onset at least 6 months prior to screening (information obtained from medical chart or subject's physician, or directly from the subject).
• Group 1 only: Subjects should have AD covering approximately 2-5% of the BSA at screening and Day 1 (excluding scalp, face, palms, soles, genitals, and folds). Subjects will treat approximately 5% of their BSA (excluding scalp, face palms, soles, genitals, and folds).
• Group 2 only: 4. Group 2 only: Subject has active AD lesions covering 2-25% of the BSA at screening and Day 1 (excluding scalp, face, palms, soles, genitals, and folds from BSA calculation).
• EASI score \>/= 5 (greater than or equal to 5) at screening and Day 1.
• vIGA-AD score ≥ 2 (greater than or equal to 2) at screening and Day 1.
• Candidate for topical treatment of AD;
• Subjects must be willing to apply an emollient of their choice during study.
• Females of child-bearing potential must have a negative urine pregnancy test at screening and on the day of the first drug administration;
• Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate through the trial and for 1 month thereafter to be eligible for, and continue participation in, the study.
• Ability to complete the study in compliance with the protocol, including agreement in writing to apply IP only to the assigned areas.
• Ability to understand and provide written informed consent.

You may not qualify if:

• Subjects with AD only located on the hands and feet.
• Subjects with clinically infected AD.
• Subjects for which systemic pharmacotherapy or phototherapy for the treatment of AD is indicated or required.
• Treatment with systemic retinoids, corticosteroids, immunomodulators or immunosuppressive agents (e.g., methotrexate, cyclosporine), cytotoxic agents, interferon, upadacitinib, abrocitinib, or baricitinib within 4 weeks of the Baseline visit or anticipated need for any of these therapies during the study period.
• Treatment with topical corticosteroids, crisaborole, ruxolitinib, Vitamin D analogs, keratolytics, coal tar, calcineurin inhibitors, antihistamines or any other therapeutic agents besides bland emollients within 2 weeks of the Baseline visit or anticipated need for any of these.
• Treatment with a biological agent (such as a monoclonal antibody) within a period of time of 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
• Subject has used systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Day 1. Of note, subjects with herpes labialis or genitalis and use of antivirals for these diseases are allowed.
• Subject has used dupilumab within 26 weeks prior to Day 1.
• Subject has used doxepin within 1 week prior to Day 1.
• Subject has used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
• Subject has used topical products containing urea within 1 week prior to Day 1.
• Subject has used medical devices, and bleach baths within 2 weeks prior to Day 1.
• Subject has had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products (except on treated lesions) and protective apparel are recommended when sun exposure cannot be avoided.
• Subject has received an intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Day 1.
• AD triggered by an unavoidable environmental allergen or irritant.

Sponsors & Collaborators

• BioMimetix JV, LLC: lead
• Innovaderm Research Inc.: collaborator

Study Sites (19)

Cahaba Dermatology & Skin Health Center

Birmingham, Alabama, 35244, United States

Location

Dermatology Trial Associates

Bryant, Arkansas, 72022, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Axon Clinical Research

Inglewood, California, 90301, United States

Location

Colorado Skin Care

Englewood, Colorado, 80113, United States

Location

Skin Care Research

Boca Raton, Florida, 33486, United States

Location

Driven Research LLC

Coral Gables, Florida, 33134, United States

Location

RM Medical Research

Miami Lakes, Florida, 33014, United States

Location

Lenus Research

Sweetwater, Florida, 33172, United States

Location

Physicians Research Group

West Lafayette, Indiana, 47906, United States

Location

Skin Sciences, Pllc

Louisville, Kentucky, 40241, United States

Location

Clinical Trials Management, LLC

Mandeville, Louisiana, 70448, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, 29420, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States

Location

Dermatology Specialists of Spokane (Dermatology Specialists of Spokane, PLLC)

Spokane, Washington, 99202, United States

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Group 1 participation is open-label. For Group 1, subjects who consent to participate in the PK portion of the study will not be randomized and will receive BMX-010. Group 2 is partially blinded. The identification of investigational product is done by lot numbers. The subject will be blinded to the treatment arm and efforts will also be made to maintain a blinded clinical center assessor in this clinical trial. This will be done by ensuring the assessor does not handle the investigational product. Additional efforts may be made to protect the study blinding to ensure at minimum the subject and assessor are blinded, and other staff as appropriate.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group 1, Group 2

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: January 8, 2023
• Primary Completion: December 30, 2023
• Study Completion: April 15, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (19)