Clinical trial NCT04731259: 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
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Epidermal Growth Factor
Papulopustular Rosacea
Lead sponsor: Azitra Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), incidence of abnormal laboratory values, abnormal physical exams and abnormal vital signs.
timeFrame: Through study completion, on average of 1 year
Secondary outcomes:
measure: Efficacy of ATR-04 assessed by IGA.
timeFrame: Up to Day 29
measure: Proportion of Subjects with Moderate or Severe Rash
timeFrame: Up to Day 29
measure: Difference in Subjects That Require Additional Therapies
timeFrame: Up to Day 29
measure: Difference in Quality of Life (QoL) of Subjects
timeFrame: Up to Day 58.
measure: Difference in Number of Inflammatory Lesions
timeFrame: Up to Day 29.
measure: Difference in Proportion of Subjects That Stop/Decrease EGFRI Therapy
timeFrame: Up to Day 29.
Other outcomes:
measure: Exploratory Endpoint to Evaluate Change in EGFRI Skin Rash Microbiome
timeFrame: Through study completion, on average of 1 year
measure: Exploratory Endpoint to Evaluate the Change in Skin Microbiome Associated with EGFRI Therapy
timeFrame: Through study completion, on average of 1 year
Locations:
city: Irving
country: United States
facility: RCTS, Inc.
state: Texas
Study officials:
References: