Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis

The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).

Study Overview

• Status: Unknown
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: PR022

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Valerie Crossley; Phone Number: 4843212700; Email: Valerie@realmtx.com
• Study Contact Backup: Name: Kathy Goin; Email: kgoin@realmtx.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19148
      • Recruiting
      • Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects 18 to 65 years of age
• EASI score ≤ 21 at baseline
• Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at Baseline
• BSA affected by AD: 5% to 20% at start of treatment
• Willing and able to apply study treatments as directed, comply with study instructions, and commit to attending all visits
• Willing and able to provide informed consent
• Use of adequate birth control, if of reproductive potential and sexually active

Exclusion Criteria:

• Widespread AD requiring systemic therapy
• Use of any of the following treatments within the specified time periods prior to Day 1
• Topical medications (topical antibiotics, topical corticosteroids, topical antifungals, topical antihistamines, topical retinoids, topical calcipotriene, tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or bleach bath within 2 weeks prior to Day 1
• Systemic agents (cyclosporine, systemic corticosteroids [oral and injectable; intranasal and inhaled corticosteroids are allowed if use is kept constant during the study], systemic antibiotics, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs [e.g., methotrexate, cyclophosphamide, azathioprine], oral retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks prior to Day 1
• Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day 1
• Biologic therapies within 12 weeks (or 5 half-lives) prior to Day 1
• Antihistamines within 5 days prior to Day 1 [stable regimens (consistent use ≥ 14 days before Day 1) of oral H1 antihistamines for non-AD lesion treatment will be allowed]
• Active or potentially recurrent dermatologic condition other than AD that may confound evaluation
• Congenital ichthyosis (note that subjects with ichthyosis vulgaris are permitted)
• Known allergy to any ingredients of the investigational product formulation
• Significant confounding conditions as assessed by Investigator
• Any condition that could interfere with any evaluation in the study
• Pregnancy or breast feeding
• Any reason which, in the opinion of the Investigator, interferes with the ability of the subject to participate in or complete the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PR022 topical gel, 0.05%; Applied twice daily for 28 days	Drug: PR022; Topical Gel
Experimental: PR022 topical gel, 0.1%; Applied twice daily for 28 days	Drug: PR022; Topical Gel
Placebo Comparator: PR022 topical gel vehicle; Applied twice daily for 28 days	Drug: PR022; Topical Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)	29 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of "Clear" (0) or "Almost Clear" (1) with a minimum 2-grade improvement at Day 29	29 Days
Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29	29 Days
Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29	29 Days
Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29	29 Days
Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD	29 Days
Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)	29 Days
Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)	29 Days
Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale	29 days
Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)	29 days
Frequency counts and percentages of DLQI scores (scored 0 to 3) at Baseline and Day 29, as well as shift in DLQI scores from Baseline to Day 29	29 Days

Other Outcome Measures

Outcome Measure	Time Frame
Change in serum IgE titer and TARC concentration from Baseline to Day 29	29 days

Collaborators and Investigators

• Sponsor: Realm Therapeutics, Inc.
• Investigators: Study Director: Christian Peters, MD, PhD, Realm

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: REALM-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No