This Trial is a Randomised, Multicentre, Investigator-blind, Vehicle and Comparator-controlled, Parallel-group Trial With the Purpose of Evaluation Efficacy, Safety and Convenience of the MC2-01 Cream

NCT03802344 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MC2-01-C7
• Study Type: interventional
• Target: 498
• Locations: 2 countries
• Sites: 2

Brief Summary

This trial is a randomized, investigator-blind, multicentre, vehicle- and comparator-controlled, parallel-group trial with the purpose of evaluating the efficacy, safety and convenience of the MC2-01 cream.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Percentage Change in mPASI (Modified Psoriasis Area and Severity Index) Score

  The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement. The severity is assessed at the 3 areas for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe. The mPASI score is calculated from the individual scores by use of the following equation: Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8. The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100 (if a reduction is seen the value will be presented as a negative number)

  8 Weeks

Secondary Outcomes (1)

• The Psoriasis Treatment Convenience Scale (PTCS)

  8 Weeks

Study Arms (3)

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

Cal/BDP combination

ACTIVE COMPARATOR

Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks

Drug: Cal/BDP combination

Vehicle

PLACEBO COMPARATOR

One application daily for 8 weeks

Drug: Vehicle

Interventions

MC2-01 cream DRUG

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream

MC2-01 Cream

Cal/BDP combination DRUG

Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%

Cal/BDP combination

Vehicle DRUG

Vehicle cream

Vehicle

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
• Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 15 g of trial medication per day
• Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)
• Have an mPASI score of at least 3
• Have a treatment area involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.

You may not qualify if:

• Current diagnosis of unstable forms of psoriasis
• Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
• Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
• Planned excessive or prolonged exposure to either natural or artificial sunlight
• History of hypersensitivity to any component of the test product or reference product
• Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
• Systemic treatment with biological therapies
• Use of systemic treatments that suppress the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to Visit 1/Baseline and during the trial
• Use of phototherapy within 4 weeks prior to Visit 1/Baseline 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 Visit 1/Baseline
• Presence of infections in the treatment area (bacteria, viruses, parasites or fungi) or skin manifestations of atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wound in the treatment area
• Known Human Immunodeficiency Virus (HIV) infection
• Have 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
• Initiation of, or expected changes to, concomitant medication that may affect psoriasis

Sponsors & Collaborators

• MC2 Therapeutics: lead

Study Sites (2)

Dermatovenerologie a korektivní dermatologie

Prague, Těšnov 1163/5 110 00, Czechia

Location

University Medical Center Hamburg

Hamburg, 20246, Germany

Location

Related Publications (3)

• Pinter A, Galvan J, Freischlager F. Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials. Dermatol Ther (Heidelb). 2025 Jun;15(6):1441-1453. doi: 10.1007/s13555-025-01418-x. Epub 2025 Apr 24.

  PMID: 40274711 DERIVED

• Stein Gold L, Pinter A, Armstrong A, Augustin M, Arenberger P, Bhatia N, Praestegaard M, Iversen L, Reich A. Calcipotriene and Betamethasone Dipropionate PAD-Cream Demonstrates Greater Treatment Efficacy in Patients with Moderate-to-Severe Psoriasis Compared to Topical Suspension/Gel: A Subgroup Analysis of Two Phase 3 Studies. Dermatol Ther (Heidelb). 2023 Sep;13(9):2031-2044. doi: 10.1007/s13555-023-00979-z. Epub 2023 Jul 25.

  PMID: 37490268 DERIVED

• Praestegaard M, Steele F, Crutchley N. Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application. Dermatol Ther (Heidelb). 2022 Oct;12(10):2217-2231. doi: 10.1007/s13555-022-00794-y. Epub 2022 Sep 1.

  PMID: 36050567 DERIVED

Results Point of Contact

• Title: Irene Sandholdt
• Organization: MC2 Therapeutics

isa@mc2therapeutics.com

+45 2015 7033

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: December 12, 2018
• Primary Completion: October 2, 2019
• Study Completion: October 2, 2019
• Last Updated: December 16, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11

Locations

CZ (1); DE (1)