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Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2% (C012013)

Primary Purpose

Atopic Dermatitis

Status

Terminated

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

MRX-6

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects, ≥2 years of age and ≤17 years of age, of any race or ethnicity
Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 (Hanifin and Rajka, Rothe 1980)
Must have AD affecting ≥ 5% total body surface area (TBSA) at Baseline
History of AD for at least 3 months prior to Baseline
Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline (21 CFR §50.25[c]) and applicable regulations, before completing any study-related procedures

Exclusion Criteria:

Use of topical corticosteroids within 7 days prior to Baseline
Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (eg, PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline
Subjects that require systemic therapy for the treatment of atopic dermatitis
Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline
Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis)
Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline
Women of childbearing potential who are lactating or pregnant as determined by urine pregnancy test at Screening. • History of MRX-6 cream 2% sensitivity or to any component of the test article
History of severe anxiety and/or depression; any history of suicide attempt
Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history
Subjects with any screening clinical laboratory result outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician
Subjects who, in the opinion of the Investigator, would be non compliant with the visit schedule or study procedures
Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct
Chronic condition(s) which are either unstable or not adequately controlled
Use of non-sedating anti-histamines within 7 days of first dose or at any time during study conduct
Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures

Sites / Locations

Dermatology Clinic
Dermatology Clinic
Lev Yasmin Clinic
Dermatology Clinic
Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

MRX-6

Arm Description

BID

Outcomes

Primary Outcome Measures

Investigator's Global Assessment

Secondary Outcome Measures

Safety

Adverse Events

Full Information

NCT ID

NCT02031445

First Posted

January 7, 2014

Last Updated

May 5, 2016

Sponsor

Celsus Therapeutics PLC

1. Study Identification

Unique Protocol Identification Number

NCT02031445

Brief Title

Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2%

Acronym

C012013

Official Title

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2% in Pediatric Subjects With Mild to Moderate Atopic Dermatitis Followed by an Open Label Extension

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

Interim analysis showed lack of efficacy

Study Start Date

August 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celsus Therapeutics PLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Randomized, double-blind, parallel group, placebo-controlled, multicenter, efficacy and safety study in subjects with mild to moderate atopic dermatitis. Following the double blind period, subjects will be allowed to continue treatment with topical MRX-6 Cream 2% in an open-label extension. Demonstrate the efficacy of MRX-6 Cream 2% compared to Vehicle for the treatment of the signs and symptoms of atopic dermatitis and demonstrate the safety of MRX-6 Cream 2% for the treatment of the signs and symptoms of atopic dermatitis.

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

BID

Arm Title

MRX-6

Arm Type

Experimental

Arm Description

BID

Intervention Type

Drug

Intervention Name(s)

MRX-6

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Investigator's Global Assessment

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Safety

Description

Adverse Events

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects, ≥2 years of age and ≤17 years of age, of any race or ethnicity Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 (Hanifin and Rajka, Rothe 1980) Must have AD affecting ≥ 5% total body surface area (TBSA) at Baseline History of AD for at least 3 months prior to Baseline Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline (21 CFR §50.25[c]) and applicable regulations, before completing any study-related procedures Exclusion Criteria: Use of topical corticosteroids within 7 days prior to Baseline Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (eg, PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline Subjects that require systemic therapy for the treatment of atopic dermatitis Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis) Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline Women of childbearing potential who are lactating or pregnant as determined by urine pregnancy test at Screening. • History of MRX-6 cream 2% sensitivity or to any component of the test article History of severe anxiety and/or depression; any history of suicide attempt Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history Subjects with any screening clinical laboratory result outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician Subjects who, in the opinion of the Investigator, would be non compliant with the visit schedule or study procedures Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct Chronic condition(s) which are either unstable or not adequately controlled Use of non-sedating anti-histamines within 7 days of first dose or at any time during study conduct Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures

Overall Study Officials: