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

Primary Purpose

Atopic Dermatitis

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PR022

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Principal InvestigatorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

PR022 topical gel, 0.05%

PR022 topical gel, 0.1%

PR022 topical gel vehicle

Arm Description

Applied twice daily for 28 days

Outcomes

Primary Outcome Measures

Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)

Secondary Outcome Measures

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

Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29

Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29

Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29

Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD

Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)

Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)

Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale

Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)

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

Full Information

NCT ID

NCT03351777

First Posted

November 20, 2017

Last Updated

December 19, 2017

Sponsor

Realm Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03351777

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 4, 2017 (Actual)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Realm Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

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

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PR022 topical gel, 0.05%

Arm Type

Experimental

Arm Description

Applied twice daily for 28 days

Arm Title

PR022 topical gel, 0.1%

Arm Type

Experimental

Arm Description

Applied twice daily for 28 days

Arm Title

PR022 topical gel vehicle

Arm Type

Placebo Comparator

Arm Description

Applied twice daily for 28 days

Intervention Type

Drug

Intervention Name(s)

PR022

Intervention Description

Topical Gel

Primary Outcome Measure Information:

Title

Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)

Time Frame

29 days

Secondary Outcome Measure Information:

Title

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

Time Frame

29 Days

Title

Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29

Time Frame

29 Days

Title

Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29

Time Frame

29 Days

Title

Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29

Time Frame

29 Days

Title

Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD

Time Frame

29 Days

Title

Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)

Time Frame

29 Days

Title

Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)

Time Frame

29 Days

Title

Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale

Time Frame

29 days

Title

Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)

Time Frame

29 days

Title

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

Time Frame

29 Days

Other Pre-specified Outcome Measures:

Title

Change in serum IgE titer and TARC concentration from Baseline to Day 29

Time Frame

29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valerie Crossley

Phone

4843212700

Valerie@realmtx.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kathy Goin

kgoin@realmtx.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Peters, MD, PhD

Organizational Affiliation

Realm

Official's Role

Study Director

Facility Information:

Facility Name

Principal Investigator

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19148

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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