Targeted Investigation of Microbiome Elimination

NCT05177328 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: DAIT ADRN-13
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the pharmacokinetics or survival of new product containing commensal infection fighting bacteria, on the skin of patients with Atopic Dermatitis (AD), after a single application.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• The Duration of ShA9 Survival on the Lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+).

  Measured as the time needed for coagulase negative staphylococcus species (CoNS) colony-forming unit (CFU) to drop below baseline density measured before application of ShA9 + 100 CFU/cm2 (time to CoNS elimination). Baseline CoNS density was defined as the CoNS (CFU/cm2) result from the sample taken prior to treatment application during the Treatment Visit (Day 0). The primary endpoint was assessed based on samples from lesional skin from the arm (left or right) that received active treatment (ShA9) among SA+ participants. The event is CoNS elimination. Participants who did not experience CoNS elimination were right-censored. The median survival time (hours) was estimated using Kaplan Meier techniques. The 95% confidence interval for median survival time was estimated based on a log-log transformation of the survivor function.

  Day 0 to Day 24

Secondary Outcomes (3)

• The Duration of ShA9 Survival on the Non-lesional Ventral Arm Skin of Atopic Dermatitis (AD) Participants Positive for S. Aureus (AD SA+).

  Day 0 to Day 24

• The Count of Serious Treatment-emergent Adverse Events Per Participant.

  Day 0 to Day 31

• The Count of Non-serious Treatment-emergent Adverse Events Per Participant.

  Day 0 to Day 31

Study Arms (1)

ShA9

EXPERIMENTAL

All participants will receive ShA9 active treatment on one of their ventral arms and placebo on their contralateral arm. The assignment of ShA9 and placebo to the dominant and non-dominant arms will be randomized.

Biological: S. hominis A 9 Product; Drug: Placebo

Interventions

S. hominis A 9 Product BIOLOGICAL

Commensal staph species, phosphate buffered saline, and glycerol.

Also known as: ShA9

ShA9

Placebo DRUG

Phosphate buffered saline and glycerol

Also known as: Placebo for S. hominis A 9 Product

ShA9

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be able to understand and provide informed consent
• Meet Atopic Dermatitis Research Network (ADRN) Standard Diagnostic Criteria for active atopic dermatitis (AD)
• At least 21 cm\^2 of lesional and 21 cm\^2 of non-lesional skin on both the right and left ventral arms. The required area (lesional or non-lesional) may be one contiguous area or may encompass multiple areas with a total cumulative area of 21 cm\^2
• An Investigator Global Assessment (IGA) score, on the ventral arms of at least moderate severity
• Body surface area (BSA), as measured by Mostellar BSA Calculator, between 1.26 m\^2 and 2.25 m\^2
• If female of child bearing potential, must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraception (e.g. oral contraceptives, intrauterine device \[IUD\], barrier method with spermicide, or surgically sterilized partner, Depo- Provera, Norplant, NuvaRing, or hormonal implants) for the duration of study participation

You may not qualify if:

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol
• Pregnant or lactating females
• Active bacterial, viral, or fungal skin infections
• Any noticeable breaks or cracks in the skin on the target areas of investigational product application, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection
• Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Cetaphil® Lotion, alcohol-based cleaners, glycerol, or soy products
• Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
• Any participant who is immunocompromised (e.g. history of lymphoma, Human Immunodeficiency Virus \[HIV\]/Acquired Immunodeficiency Syndrome \[AIDS\], Wiskott-Aldrich Syndrome), has an immune system disorder (e.g. autoimmune disease), or is using a systemic immunosuppressant (e.g. systemic corticosteroids, cyclosporine, methotrexate)
• Any participant with current malignant disease (with the exception of non-melanoma skin cancer in an area not affected by treatment)
• Participants with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
• Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
• Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or 5 half-lives (if known), whichever is longer, of the Screening Visit
• Treatment with non-steroid systemic immunosuppressant within 6 months of the Screening Visit
• Treatment with Dupilumab within 16 weeks of the Screening Visit
• Treatment with oral or injectable therapy for AD (excluding oral steroids) within 5 half-lives (if known) or 16 weeks before the Screening Visit, whichever is longer
• Participants with close contacts (e.g. spouse, children, or members in the same household) that have severe barrier defects or are immunocompromised

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Atopic Dermatitis Research Network: collaborator

Study Sites (1)

University of California, San Diego: Dermatology Clinical Trials Unit

La Jolla, California, 92093, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

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: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Richard Gallo, M.D., Ph.D.

  University of California, San Diego: Dermatology Clinical Trials Unit

  STUDY CHAIR

• Tissa Hata, M.D.

  University of California, San Diego: Dermatology Clinical Trials Unit

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study, as all participants will receive active and placebo treatment. Participants will receive active treatment on one of their ventral arms and placebo on their contralateral ventral arm. Investigators, all investigational site staff, including those responsible for preparing/administering the investigational product, and all participants in this study will be blinded as to which arm received which treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: July 18, 2022
• Primary Completion: August 27, 2023
• Study Completion: October 13, 2023
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-10

Locations

US (1)