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Study to Evaluate the Safety of ATR-04

Studies

Study First Submitted Date 2021-01-14
Study First Posted Date 2021-01-29
Last Update Posted Date 2021-06-07
Start Month Year January 2024
Primary Completion Month Year January 2026
Verification Month Year June 2021
Verification Date 2021-06-30
Last Update Posted Date 2021-06-07

Detailed Descriptions

Sequence: 20605669
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).

Facilities

Sequence: 198917675
Name RCTS, Inc.
City Irving
State Texas
Zip 75062
Country United States

Conditions

Sequence: 51874928 Sequence: 51874929
Name Epidermal Growth Factor Name Papulopustular Rosacea
Downcase Name epidermal growth factor Downcase Name papulopustular rosacea

Id Information

Sequence: 39923113
Id Source org_study_id
Id Value CTAR-403

Countries

Sequence: 42318126
Name United States
Removed False

Design Groups

Sequence: 55296743 Sequence: 55296744
Group Type Experimental Group Type Placebo Comparator
Title ATR-04 Title Placebo
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. Description 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.

Interventions

Sequence: 52193417 Sequence: 52193418
Intervention Type Drug Intervention Type Other
Name ATR-04 Name Placebo
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. Description Placebo

Design Outcomes

Sequence: 176399230 Sequence: 176399231 Sequence: 176399232 Sequence: 176399233 Sequence: 176399234 Sequence: 176399235 Sequence: 176399236 Sequence: 176399237 Sequence: 176399238
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type other Outcome Type other
Measure Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), incidence of abnormal laboratory values, abnormal physical exams and abnormal vital signs. Measure Efficacy of ATR-04 assessed by IGA. Measure Proportion of Subjects with Moderate or Severe Rash Measure Difference in Subjects That Require Additional Therapies Measure Difference in Quality of Life (QoL) of Subjects Measure Difference in Number of Inflammatory Lesions Measure Difference in Proportion of Subjects That Stop/Decrease EGFRI Therapy Measure Exploratory Endpoint to Evaluate Change in EGFRI Skin Rash Microbiome Measure Exploratory Endpoint to Evaluate the Change in Skin Microbiome Associated with EGFRI Therapy
Time Frame Through study completion, on average of 1 year Time Frame Up to Day 29 Time Frame Up to Day 29 Time Frame Up to Day 29 Time Frame Up to Day 58. Time Frame Up to Day 29. Time Frame Up to Day 29. Time Frame Through study completion, on average of 1 year Time Frame Through study completion, on average of 1 year
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. Description Assess the efficacy of ATR-04 compared to placebo to mitigate the severity of EGFRI-associated skin effects as assessed by IGA. Description Difference in proportion of subjects with moderate or severe facial rash as assessed by IGA. 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. 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. Description Difference in number of inflammatory lesions on face for subjects on ATR-04 compared to placebo. Description Difference in proportion of subjects that stop or decrease dose of EGFRI therapy. Description Evaluate the microbiome of EGFRI skin rashes as determined by shotgun sequencing. Description Evaluate the change in skin microbiome associated with EGFRI therapy as determined by shotgun sequencing.

Browse Conditions

Sequence: 192288205 Sequence: 192288206
Mesh Term Rosacea Mesh Term Skin Diseases
Downcase Mesh Term rosacea Downcase Mesh Term skin diseases
Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48042573
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Azitra Inc.

Design Group Interventions

Sequence: 67789490 Sequence: 67789491
Design Group Id 55296743 Design Group Id 55296744
Intervention Id 52193417 Intervention Id 52193418

Eligibilities

Sequence: 30590731
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253876636
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6
Number Of Other Outcomes To Measure 2

Designs

Sequence: 30338485
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Subject Masked True
Caregiver Masked True

Responsible Parties

Sequence: 28715746
Responsible Party Type Sponsor