Study to Evaluate the Safety of ATR-04

NCT04731259 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: CTAR-403
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. This study will be performed at 10-12 clinical sites, with potentially a virtual component. Approximately 60 eligible subjects will participate. A subject's participation in the study will be up to a maximum of 86 days (up to 28 days for Screening, 28 days of BID treatment, and a 30 day no treatment follow-up period). The primary objective of this study is to evaluate the safety and tolerability of ATR-04 compared to placebo.

Conditions

Epidermal Growth Factor; Papulopustular Rosacea

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), incidence of abnormal laboratory values, abnormal physical exams and abnormal vital signs.

  Safety and tolerability of ATR-04 compared to placebo as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory values, physical exams and vital signs.

  Through study completion, on average of 1 year

Secondary Outcomes (6)

• Efficacy of ATR-04 assessed by IGA.

  Up to Day 29

• Proportion of Subjects with Moderate or Severe Rash

  Up to Day 29

• Difference in Subjects That Require Additional Therapies

  Up to Day 29

• Difference in Quality of Life (QoL) of Subjects

  Up to Day 58.

• Difference in Number of Inflammatory Lesions

  Up to Day 29.

Other Outcomes (2)

• Exploratory Endpoint to Evaluate Change in EGFRI Skin Rash Microbiome

  Through study completion, on average of 1 year

• Exploratory Endpoint to Evaluate the Change in Skin Microbiome Associated with EGFRI Therapy

  Through study completion, on average of 1 year

Study Arms (2)

ATR-04

EXPERIMENTAL

The intervention is an ointment that will be applied topically BID for 28 days. It will be supplied in small aluminum foil packets. Packets of study medication will be labeled with Subject Kit numbers to ensure the double-blind treatment.

Drug: ATR-04

Placebo

PLACEBO COMPARATOR

Placebo ointment will be applied topically BID for 28 days. It will be supplied in small aluminum foil packets. Packets of study medication will be labeled with Subject Kit numbers to ensure the double-blind treatment.

Other: Placebo

Interventions

ATR-04 DRUG

ATR-04 is a proprietary formulated product containing lyophilized SEΔΔΔ, a Staphylococcus epidermidis genetically modified to be auxotrophic to D-alanine as the active ingredient.

ATR-04

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject must be at least 18 years of age inclusive, at the time of signing the informed consent
• Subjects with a current diagnosis of cancer
• IGA grade of 0 on the face
• Life expectancy, in the Investigator's opinion, greater than 12 weeks
• Plan to initiate treatment with one of the following EGFRI drugs (other treatments may be considered after consultation with the Sponsor): Cetuximab or Panitumumab or erlotinib
• Able to use Dove sensitive skin body wash for the duration of the treatment period.
• Acceptable and willing to delay start of EGFRI therapy until study eligibility is determined
• Anticipated to continue EGFRI therapy for at least 28 days after the first application of study medication
• Male and/or female
• Contraceptive use by men or women consistent with the EGFRI treatment package insert regarding the methods of contraception for those participating in clinical studies
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.

You may not qualify if:

• Active bacterial skin infections on the face
• Inter-current illness that in the Investigator's opinion puts the subject at undue risk by study participation or interfere with the study conduct or evaluations
• Pregnant women
• EGFRI therapy within the previous 12 weeks
• Radiation therapy exposure to the face within the previous 8 weeks
• Use of topical steroids on the face within the previous 4 weeks
• Use of systemic antibiotics or topical antibiotics on the face in the previous 7 days
• Participation in an investigational clinical study in which administration of an investigational study medication occurred with the previous 30 days

Sponsors & Collaborators

• Azitra Inc.: lead

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 29, 2021
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share