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

NCT03351777 | Unknown Phase 2 FDA Drug

• 1 other identifier: REALM-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  29 days

Secondary Outcomes (10)

• 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

Other Outcomes (1)

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

  29 days

Study Arms (3)

PR022 topical gel, 0.05%

EXPERIMENTAL

Applied twice daily for 28 days

Drug: PR022

PR022 topical gel, 0.1%

EXPERIMENTAL

Applied twice daily for 28 days

Drug: PR022

PR022 topical gel vehicle

PLACEBO COMPARATOR

Applied twice daily for 28 days

Drug: PR022

Interventions

PR022 DRUG

Topical Gel

PR022 topical gel vehicle; PR022 topical gel, 0.05%; PR022 topical gel, 0.1%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Realm Therapeutics, Inc.: lead

Study Sites (1)

Principal Investigator

Philadelphia, Pennsylvania, 19148, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Christian Peters, MD, PhD

  Realm

  STUDY DIRECTOR

Central Study Contacts

Valerie Crossley

CONTACT

4843212700; Valerie@realmtx.com

Kathy Goin

CONTACT

kgoin@realmtx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: December 4, 2017
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

US (1)