Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

NCT03824405 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BTX.2018.003
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 31

Brief Summary

This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.

Conditions

Atopic Dermatitis

Keywords

CBD; Synthetic CBD; Cannabidiol

Outcome Measures

Primary Outcomes (1)

• Investigator's Global Assessment (IGA)

  Investigator's Global Assessment (IGA) success defined as an IGA score of "Clear" (0) or "Almost Clear" (1) with at least a 2-grade improvement

  Day 85

Study Arms (2)

BTX 1204

ACTIVE COMPARATOR

BTX 1204 twice daily

Drug: BTX 1204

Vehicle

PLACEBO COMPARATOR

Vehicle twice daily

Drug: Vehicle

Interventions

BTX 1204 DRUG

BTX 1204 liquid formulation

BTX 1204

Vehicle DRUG

Vehicle liquid formulation

Vehicle

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is of either gender between 12 and 70 years of age, inclusive.
• Subject (or parent/legal guardian) has the ability and willingness to sign a written informed consent.
• Subject has a diagnosis of chronic (≥1 year), stable atopic dermatitis (AD)
• Subject has ≥ 5% and ≤ 30% body surface area (BSA) of AD involvement excluding the scalp and groin.
• Subject has an Investigator's Global Assessment (IGA) score of moderate (3) atopic dermatitis on the 5-point IGA (0-4) scale.
• For selected photography sites, subject has a target lesion of 25 to 200 cm2 in surface area on the trunk, upper extremities or lower extremities with a Baseline Signs of AD score of ≥ 6 and ≤ 12.
• Subject is in good general health without clinically significant hematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator.
• Subject has suitable venous access for blood sampling.
• Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
• Male subjects and their partners must agree and commit to use a barrier method of contraception throughout the study and for 90 days after last study drug application.
• A negative urine pregnancy test result for all Women of child bearing potential (WOCBP) at the Screening Visit and Baseline Visit.
• Sexually active women must agree to use the following throughout the study and for 30 days after last study drug application. WOCBP who are not sexually active at Baseline and become sexually active must identify a plan for contraception.
• One of these highly effective contraception methods Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation; partner vasectomy, OR
• Oral contraceptives WITH a barrier method (listed below), OR
• Two barrier forms of contraception (listed below) Male or female condom; diaphragm; cervical cap; contraceptive sponge.

You may not qualify if:

• Female subject who is breast feeding, pregnant, or planning to become pregnant.
• Subject who has an IGA score of 2 (mild) or 4 (severe).
• Subject with history of known or suspected intolerance to the drug product excipients.
• Subject has any clinically significant active infection in the investigator's opinion. This includes active impetigo at any AD lesion.
• Subject has known Hepatitis-B, Hepatitis-C, or HIV infection.
• Subject has excessive body or facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of AD.
• Subject has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality that would result in the inability to evaluate the AD lesions.
• Subject has clinically significant or severe allergies that in the investigator's opinion would interfere with participation in the study.
• Subject has known intolerability to topical treatments e.g., reports excessive burning/stinging or pain with use of topical treatments.
• Subject has an active or potentially recurring skin conditions(s) other than AD that in the investigator's opinion would interfere with participation in the study.
• Subject has unstable AD consistent with a requirement for high-potency corticosteroids.
• Subject has used dupilumab (Dupixent) within 12 weeks prior to the Baseline Visit.
• Subject has used any biologic therapy, other than dupilumab, within 28 days prior to the Baseline Visit.
• Subject has used systemic (oral, IV or IM) corticosteroids within 28 days prior to the Baseline Visit. Intra-articular injection for arthroses allowed.
• Subject has used topical anti-pruritics (e.g., PDE4 inhibitors) within 28 days prior to the Baseline Visit.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

Study Sites (31)

Applied Research Center of Arkansas Inc.

Little Rock, Arkansas, 72212, United States

Location

T. Joseph Raoff MD Inc. / Encino Research Center

Encino, California, 91436, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Dermatology Specialist Inc. - Murrieta

Murrieta, California, 92562, United States

Location

Rady Childern's Hospital - San Diego

San Diego, California, 92123, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Precision Clinical Research

Davie, Florida, 33328, United States

Location

Troy Sullivan

North Miami Beach, Florida, 33162, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Delright Research

New Orleans, Louisiana, 70115, United States

Location

Medisearch Clinical Trails

Saint Joseph, Missouri, 64506, United States

Location

Washington Univerisy in St. Louis

St Louis, Missouri, 63141, United States

Location

JDR Dermatology Research LLC

Las Vegas, Nevada, 89148, United States

Location

The Acne Treatment and Research Center

Morristown, New Jersey, 07960, United States

Location

Aventiv Research Inc - Dublin

Dublin, Ohio, 43016, United States

Location

Greenville Dermatology, LLC

Greenville, South Carolina, 29607, United States

Location

Dermresearch Inc

Austin, Texas, 78759, United States

Location

J&S Studies Inc.

College Station, Texas, 77845, United States

Location

The Center for Skin Research at Suzanne Bruce & Associates Dermatology

Houston, Texas, 77056, United States

Location

CMAX Clincial Research

Adelaide, 5000, Australia

Location

BurwoodDermatology

Burwood, 6100, Australia

Location

Sinclair Dermatology

East Melbourne, 3002, Australia

Location

North Eastern Health Specialists

Hectorville, 5073, Australia

Location

Premier Specialists PTY LTD

Kogarah, 2217, Australia

Location

St George Dermatology & Skin Cancer Center

Kogarah, 2217, Australia

Location

Captain Stirling Medical Centre

Nedlands, 6009, Australia

Location

The Skin Hospital

Westmead, 2145, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

Clinical Trials New Zealand LTD

Hamilton, 3204, New Zealand

Location

P3 Research

Wellington, 6021, New Zealand

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

Results Point of Contact

• Title: Head of Development
• Organization: Botanix Pharmaceuticals

trials@botanixpharma.com

+1 (445) 300-3403

Study Officials

• Anthony Robinson, CRNP

  Head of Development, Botanix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 29, 2019
• First Posted: January 31, 2019
• Study Start: February 4, 2019
• Primary Completion: January 27, 2020
• Study Completion: March 4, 2020
• Last Updated: October 25, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); AU (9); NZ (3)