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Study to Evaluate the Safety of ATR-04

Primary Purpose

Epidermal Growth Factor, Papulopustular Rosacea

Status

Suspended

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ATR-04

Placebo

About this trial

This is an interventional treatment trial for Epidermal Growth Factor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

RCTS, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ATR-04

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy of ATR-04 assessed by IGA.

Assess the efficacy of ATR-04 compared to placebo to mitigate the severity of EGFRI-associated skin effects as assessed by IGA.

Proportion of Subjects with Moderate or Severe Rash

Difference in proportion of subjects with moderate or severe facial rash as assessed by IGA.

Difference in Subjects That Require Additional Therapies

Difference in number of subjects that require additional therapies for the facial rash, such as antibiotics or steroids for ATR-04 compared to placebo.

Difference in Quality of Life (QoL) of Subjects

Difference in QoL of subjects on ATR-04 compared to placebo as assessed by FACT-EGFRI-18. Score ranges from 0-72, with higher scores indicating better outcomes.

Difference in Number of Inflammatory Lesions

Difference in number of inflammatory lesions on face for subjects on ATR-04 compared to placebo.

Difference in Proportion of Subjects That Stop/Decrease EGFRI Therapy

Difference in proportion of subjects that stop or decrease dose of EGFRI therapy.

Full Information

NCT ID

NCT04731259

First Posted

January 14, 2021

Last Updated

June 2, 2021

Sponsor

Azitra Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04731259

Brief Title

Study to Evaluate the Safety of ATR-04

Official Title

A Phase 1b/2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of ATR-04 to Reduce the Severity of Epidermal Growth Factor Inhibitor Associated Papulopustular Rash

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Suspended

Why Stopped

Business reasons.

Study Start Date

January 2024 (Anticipated)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azitra Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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. After informed consent is obtained, subjects will enter a screening period for up to 28 days to determine eligibility prior to randomization. Approximately 60 eligible subjects, will be randomized to receive ATR-04 or a placebo, in a ratio of 1:1. On Day 1, subjects will be instructed on study medication administration technique, the first application by the subject will be observed in person, via telehealth or via video connection and the subject will be monitored for adverse events (AEs) for at least 20 minutes. Subjects will perform twice daily (BID) study assigned medication applications for 28 days. Subjects will have in person or virtual visits throughout the study. Subjects will return all study materials (i.e. diary cards, and study medication containers, swabs) either in person or via mail on Day 29 for their End of Treatment visit. Beginning on Day 1, subjects will be assessed for safety. In addition, subjects' faces will be examined and assessed utilizing the Investigator Global Assessment (IGA) in person or via a virtual visit. Subjects will complete the Quality of Life (QoL) tool and standardized digital photographs will be taken. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epidermal Growth Factor, Papulopustular Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ATR-04

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

ATR-04

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Through study completion, on average of 1 year

Secondary Outcome Measure Information:

Title

Efficacy of ATR-04 assessed by IGA.

Description

Assess the efficacy of ATR-04 compared to placebo to mitigate the severity of EGFRI-associated skin effects as assessed by IGA.

Time Frame

Up to Day 29

Title

Proportion of Subjects with Moderate or Severe Rash

Description

Difference in proportion of subjects with moderate or severe facial rash as assessed by IGA.

Time Frame

Up to Day 29

Title

Difference in Subjects That Require Additional Therapies

Description

Difference in number of subjects that require additional therapies for the facial rash, such as antibiotics or steroids for ATR-04 compared to placebo.

Time Frame

Up to Day 29

Title

Difference in Quality of Life (QoL) of Subjects

Description

Difference in QoL of subjects on ATR-04 compared to placebo as assessed by FACT-EGFRI-18. Score ranges from 0-72, with higher scores indicating better outcomes.

Time Frame

Up to Day 58.

Title

Difference in Number of Inflammatory Lesions

Description

Difference in number of inflammatory lesions on face for subjects on ATR-04 compared to placebo.

Time Frame

Up to Day 29.

Title

Difference in Proportion of Subjects That Stop/Decrease EGFRI Therapy

Description

Difference in proportion of subjects that stop or decrease dose of EGFRI therapy.

Time Frame

Up to Day 29.

Other Pre-specified Outcome Measures:

Title

Exploratory Endpoint to Evaluate Change in EGFRI Skin Rash Microbiome

Description

Evaluate the microbiome of EGFRI skin rashes as determined by shotgun sequencing.

Time Frame

Through study completion, on average of 1 year

Title

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

Description

Evaluate the change in skin microbiome associated with EGFRI therapy as determined by shotgun sequencing.

Time Frame

Through study completion, on average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Facility Information:

Facility Name

RCTS, Inc.

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Study to Evaluate the Safety of ATR-04

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