A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream

December 9, 2019 updated by: MC2 Therapeutics

A Randomised, Open-label, Maximal Use Trial, Evaluating the Pharmacokinetic Profile of Active Ingredients and Their Metabolites After Application of MC2-01 Cream Compared With Active Comparator in Subjects With Extensive Psoriasis Vulgaris

This is a phase 2, randomised, open-label, parallel-group, multicentre trial in which MC2-01 cream and calcipotriene [CAL]/betamethasone [BDP] ointment (comparator) is investigated in subjects with clinically diagnosed extensive psoriasis vulgaris.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The MC2-01 cream is designed for optimal patient satisfaction - it quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on with daily routines. In this trial, the MC2-01 cream will be compared to a marketed calcipotriene [CAL]/betamethasone dipropionate [BDP] ointment. The purpose of the trial, is to determine the pharmacokinetic parameters of MC2-01 cream and the comparator under maximum use conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sweetwater, Florida, United States, 33172
        • Lenus Research and Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have provided written informed consent.
  • Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening.
  • At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving scalp and body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 100 g of trial medication per week.
  • Have a Physician's Global Assessment [PGA] of severity of at least moderate on the trunk, limbs and/or scalp, at Visit 1/Day 0.
  • Have a treatment area between 20% and 30% of the body surface area [BSA] on the trunk, limbs and/or scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0.

Exclusion Criteria:

  • Current diagnosis of unstable forms of psoriasis
  • Other inflammatory skin disease in the treatment area
  • Pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
  • Planned exposure to natural or artificial sunlight
  • Phototherapy and ultraviolet B radiation within 4 weeks prior to Visit 1/Baseline and during the trial;
  • Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders;
  • Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within 4 weeks prior to Visit 1/Day 0 during the trial period.
  • Planned initiation of, or changes to concomitant medication that could affect calcium metabolism during the trial;
  • Planned initiation of, or changes to, concomitant estrogen therapy during the trial;
  • Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors within 4 weeks prior to Vist 1/Day 0 and during the trial period;
  • Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Day 0 and during the trial period;
  • Systemic treatment with biological therapies
  • Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial period;
  • Depression and endocrine disorders known to affect cortisol levels or HPA axis integrity, non-nocturnal sleep patterns
  • Systemic medication that suppresses the immune system within 4 weeks prior to the Visit 1/Day 0 and during the trial period;
  • Clinical signs of skin infection with bacteria, viruses, or fungi;
  • Known human immunodeficiency virus [HIV] infection;
  • Known or suspected of hypersensitivity to any component of the test product or reference product;
  • Any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MC2-01 Cream
MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%).
Drug: MC2-01 Cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
Active Comparator: CAL/BDP combination
CAL/BDP ointment (w/w 0.005%/0.064%).
Drug: CAL/BDP combination
Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
Time Frame: Week 4
Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Week 4
Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
Time Frame: Week 8
Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Week 8
Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
Time Frame: Week 4
Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Week 4
Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
Time Frame: Week 8
Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Week 8
Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
Time Frame: Week 4
Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Week 4
Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
Time Frame: Week 8
Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Week 8
Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
Time Frame: Week 4
Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Week 4
Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
Time Frame: Week 8
Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment
Time Frame: Week 4

The HPA axis evaluation is based on an Adrenocorticotropic hormone [ACTH] challenge test, defined by a 30 minutes ACTH stimulated cortisol value. Only subject with no HPA suppression at baseline were included in the analysis.

The outcome measure lists the number of subjects with HPA suppression 30 minutes after ACTH challenge
Week 4
Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment
Time Frame: Week 8
The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline
Week 8
Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Time Frame: Baseline and week 4
Changes from baseline of albumin-corrected serum calcium [mmol/L]
Baseline and week 4
Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Time Frame: Baseline and week 8
Changes from baseline in albumin-corrected serum calcium [mmol/L]
Baseline and week 8
Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Time Frame: Baseline and week 4
Changes from baseline of 24-hour urinary calcium excretion [mmol/day]
Baseline and week 4
Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Time Frame: Baseline and week 8
Changes from baseline of 24-hour urinary calcium excretion [mmol/day]
Baseline and week 8
Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
Time Frame: Baseline and week 4
Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)
Baseline and week 4
Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
Time Frame: Baseline and week 8
Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)
Baseline and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MC2 Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: George Han, Department of Dermatology, Mount Sinai Beth Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MC2-01-C3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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