Clinical trial NCT03462927: A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: MC2 Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-03-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
timeFrame: Week 4
measure: Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
timeFrame: Week 8
measure: Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
timeFrame: Week 4
measure: Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
timeFrame: Week 8
measure: Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
timeFrame: Week 4
measure: Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
timeFrame: Week 8
measure: Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
timeFrame: Week 4
measure: Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
timeFrame: Week 8
Secondary outcomes:
measure: Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment
timeFrame: Week 4
measure: Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment
timeFrame: Week 8
measure: Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
timeFrame: Baseline and week 4
measure: Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
timeFrame: Baseline and week 8
measure: Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
timeFrame: Baseline and week 4
measure: Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
timeFrame: Baseline and week 8
measure: Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
timeFrame: Baseline and week 4
measure: Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
timeFrame: Baseline and week 8
Other outcomes:
Locations:
city: Sweetwater
country: United States
facility: Lenus Research and Medical Group
state: Florida
Study officials:
affiliation: Department of Dermatology, Mount Sinai Beth Israel
name: George Han
role: PRINCIPAL_INVESTIGATOR
References: