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

NCT03819218 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: MC2-01-C6
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 2

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (6)

• Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at 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

  Week 4

• Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at 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

  Week 8

• Change in S-Calcium Metabolism at Week 4

  Change from Baseline to Week 4 in albumin-corrected S-calcium

  Week 4

• Change in S-Calcium Metabolism at Week 8

  Change from Baseline to Week 8 in albumin-corrected S-calcium

  Week 8

• Change in U-Calcium Metabolism at Week 4

  Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)

  Week 4

• Change in U-Calcium Metabolism at Week 8

  Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)

  Week 8

Secondary Outcomes (2)

• The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4

  Week 4

• Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4

  Week 4

Study Arms (1)

MC2-01 cream

EXPERIMENTAL

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks

Drug: MC2-01 cream

Interventions

MC2-01 cream DRUG

MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)

MC2-01 cream

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 intertriginous 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MC2 Therapeutics: lead

Study Sites (2)

PRO SANUM a.s.

Prague, 110 00, Czechia

Location

Dept. of Dermatology, Venereology and Allergology

Frankfurt, Frankfurt/Main, 60590, Germany

Location

Results Point of Contact

• Title: Irene Sandholdt
• Organization: MC2 Therapeutics

isa@mc2therapeutics.com

+45 2015 7033

Study Officials

• Andreas Pinter, MD

  Dept. of Dermatology, Venereology and Allergology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 28, 2019
• Study Start: December 27, 2018
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: March 19, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

CZ (1); DE (1)