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Atopic DermatitisPhase 2C012013NCT02031445

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

A Phase 2 study testing MRX-6 in people with Atopic Dermatitis, run by Celsus Therapeutics PLC at 5 sites in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
MRX-6
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
5 sitesIsrael
Study dates
Aug 2014to Mar 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Israel5 sites

  • Dermatology Clinic

    Kfar Saba

  • Dermatology Clinic

    Kiryat Ono

  • Lev Yasmin Clinic

    Netanya

  • Dermatology Clinic

    Petah Tikva

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

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

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.

Being tested
MRX-6, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRX-6Drug

  • PlaceboOther

Study groups in NCT02031445
Study groupRoleWhat they receive
PlaceboPlacebo comparatorBID
Receives: Other: Placebo
MRX-6ExperimentalBID
Receives: Drug: MRX-6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator's Global Assessment

    Measured: 4 weeks

Secondary outcomes (1)

  1. Safety

    Adverse Events

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Why it stopped: Interim analysis showed lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02031445
Sponsor's protocol ID
C012013
Acronym
C012013
Status last verified
May 2016
First submitted
7 Jan 2014
Last updated
6 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRX-6 in people with Atopic Dermatitis, run by Celsus Therapeutics PLC at 5 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Interim analysis showed lack of efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator's Global Assessment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02031445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.

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