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

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ClinicalTrials.gov Identifier: NCT03819218
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)

Tracking Information
First Submitted Date  ICMJE January 11, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date January 28, 2019
Actual Study Start Date  ICMJE December 27, 2018
Estimated Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • Hypothalamic-pituitary-adrenal (HPA) axis [ Time Frame: Week 4 ]
    Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
  • Hypothalamic-pituitary-adrenal (HPA) axis [ Time Frame: Week 8 ]
    Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
  • Calcium metabolism [ Time Frame: Week 4 ]
    Changes from baseline in albumin-corrected S-calcium
  • Calcium metabolism [ Time Frame: Week 8 ]
    Changes from baseline in albumin-corrected S-calcium
  • Calcium metabolism [ Time Frame: Week 4 ]
    Changes from baseline in ratio of urine calcium to creatinine
  • Calcium metabolism [ Time Frame: Week 8 ]
    Changes from baseline in ratio of urine calcium to creatinine
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • Pharmacokinetic parameters of active ingredients and their main metabolite [ Time Frame: Week 4 ]
    Area under the time-concentration curve from time zero to the last measurable concentration [AUC0-t]
  • Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 ]
    Area under the time-concentration curve from time zero to 5 hours [AUC0-5]
  • Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 ]
    Maximum Plasma Concentration [Cmax]
  • Pharmacokinetic parameters of active ingredients and their main metabolites [ Time Frame: Week 4 ]
    Time to maximum plasma drug concentration [Tmax]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream in Adolescent Subjects
Official Title  ICMJE A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and Their Metabolites After Application of MC2-01 Cream in Adolescents With Extensive Psoriasis Vulgaris
Brief Summary This is a phase 2, open-label, single-group, multicentre trial in which the investigational product, MC2-01 cream, is investigated in adolescent subjects (age 12 to 16 years, 11 months) with clinically diagnosed extensive psoriasis vulgaris.
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, subjects who fulfil all inclusion and exclusion criteria are enrolled in the trial and will apply one dose of trial medication topically once daily for 8 weeks. The purpose of the trial, is to determine the and pharmacokinetic parameters of MC2-01 cream in adolescent subjects under maximum use conditions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE Drug: MC2-01 cream
MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
Study Arms  ICMJE Experimental: MC2-01 cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks
Intervention: Drug: MC2-01 cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 17, 2020
Estimated Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The parent(s), or legal guardian(s) (according to national law) have provided written informed consent following their receipt of verbal and written information about the trial
  • The subject (according to national law) has provided written assent to the trial following their receipt of verbal and written information about the trial
  • Generally healthy males or non-pregnant females, of any race or ethnicity, who are between 12 to 16 years, 11-month-old at Screening Visit 1 (SV1)
  • At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving body (trunk and/or limbs), with or without scalp
  • Have a treatment area between 10% and 30% of the Body Surface Area (BSA) on the body (trunk and/or limbs) and scalp, excluding psoriatic lesions on the face, genitals, and intertrigenous areas, at Visit 1/Day 0
  • Have a Physician's Global Assessment (PGA) of at least moderate severity on the treatment area
  • A normal HPA axis function including a serum cortisol concentration above 4,5 mcg/dl before ACTH-challenge and equal or above 18 mcg/dl 30 minutes after ACTH challenge, at Screening Visit 2 (SV2)
  • A serum albumin-corrected calcium below the upper reference limit at SV2

Exclusion Criteria:

  • Have a current diagnosis of unstable forms of psoriasis, including erythrodermic or pustular psoriasis
  • Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
  • Presence of infections in the treatment area or skin manifestations or atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds in the treatment area
  • Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters
  • Planned excessive or prolonged exposure to either natural or artificial sunlight
  • Use of phototherapy (psoralen + ultraviolet A radiation and ultraviolet B radiation within 4 weeks prior to SV2 and during the trial
  • Current or past history of disorders of calcium metabolism associated with 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 SV2
  • 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 or inducers within 4 weeks prior to SV2 and during the trial
  • Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to SV2 and during the trial
  • Systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within the following time period prior to SV2 and during the trial
  • Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial
  • Any of the following conditions, whether known or suspected; Clinically diagnosed depression where the subject is in current treatment with medication approved for treatment of depression; Endocrine disorders known to affect cortisol levels or HPA axis integrity; Non-nocturnal sleep patterns
  • Use of systemic medication that suppresses the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to the SV2 and during the trial
  • Use of live vaccines 4 weeks before SV2 and during the trial
  • Have clinical signs of skin infection with bacteria, viruses, or fungi
  • Known human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C
  • Known or suspected of hypersensitivity to any component of the test product
  • Known allergic asthma, serious allergies or allergies where recurrent acute or chronic treatment is necessary
  • Have any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial
  • Require the use of any concomitant medication that, in the investigator's opinion, has the potential to cause an adverse effect when given with the Investigational Product (IP) or will interfere with the interpretation of the trial results
  • Subject with known abnormal reduction in muscle mass, as judged by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Birgitte Vestbjerg +4520772575 bve@mc2therapeutics.com
Listed Location Countries  ICMJE Czechia,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03819218
Other Study ID Numbers  ICMJE MC2-01-C6
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Study Sponsor  ICMJE Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Pinter, MD Dept. of Dermatology, Venereology and Allergology
PRS Account Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP