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

NCT03462927 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MC2-01-C3
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (8)

• Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (8)

• Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment

  Week 4

• Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment

  Week 8

• Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium

  Baseline and week 4

• Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium

  Baseline and week 8

• Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion

  Baseline and week 4

Study Arms (2)

MC2-01 Cream

EXPERIMENTAL

MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%).

Drug: MC2-01 Cream

CAL/BDP combination

ACTIVE COMPARATOR

CAL/BDP ointment (w/w 0.005%/0.064%).

Drug: CAL/BDP combination

Interventions

MC2-01 Cream DRUG

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

MC2-01 Cream

CAL/BDP combination DRUG

Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)

CAL/BDP combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• MC2 Therapeutics: lead

Study Sites (1)

Lenus Research and Medical Group

Sweetwater, Florida, 33172, United States

Location

Results Point of Contact

• Title: Birgitte Vestbjerg
• Organization: MC2 Therapeutics

bve@mc2therapeutics.com

+45 2077 2575

Study Officials

• George Han

  Department of Dermatology, Mount Sinai Beth Israel

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 13, 2018
• Study Start: February 8, 2018
• Primary Completion: August 4, 2018
• Study Completion: August 4, 2018
• Last Updated: December 24, 2019
• Results First Posted: December 24, 2019

Record last verified: 2019-12

Locations

US (1)