Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS) (Orchid 1)

A Parallel Group (2-arm), Randomised, Double-blind, 12-week Trial to Explore the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Women Diagnosed With Vulvar Lichen Sclerosus (VLS)

The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS).

Study Overview

• Status: Recruiting
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Drug: MC2-25 cream; Drug: MC2-25 vehicle

Detailed Description

In this study, subjects who fulfil all inclusion and exclusion criteria are enrolled.

Eligible subjects will be randomized in a 1:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.

The subjects will apply the assigned investigational medicinal product (IMP) daily for 12 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Maj Dinesen, MD; Phone Number: +45 2851 9302; Email: mdi@mc2therapeutics.com

Study Locations

• Denmark
  • Kolding, Denmark
    • Recruiting
    • MC2 Therapeutics study site
    • Contact: Principal Investigator, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women, of any race or ethnicity, who are ≥18 years of age at the time of screening.
• Able to understand the trial and willing to comply with trial requirements.
• Has provided written informed consent.
• Clinical diagnosis of VLS.
• Presence of at least one of the following signs of VLS: Hyperkeratosis and/or Sclerosis.
• First symptoms of VLS noticed by the patient at least 6 months before baseline.
• At least four WI-NRS scores available in the diary for calculation of the average WI-NRS at the baseline visit.
• At least moderate itch defined as average WI-NRS ≥4 at the Baseline visit.
• Women must be of either of non-childbearing potential or childbearing potential with a negativ urine pregnancy test at baseline.
• Women of childbearing potential must agree to use a highly effective method of contraception.

Exclusion Criteria:

• Pregnant, breast feeding, or planning to become pregnant during the trial.
• Any (other than VLS) ongoing localized or systemic disease involving the vulvar region.
• Ongoing symptomatic Urinary Tract Infection.
• Ongoing or prior diagnosis of any genitoanal malignancy or pre-malignancy.
• Any kind of ongoing cancer prior to the Baseline visit.
• Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with the assessment of efficacy in this trial.
• Known history of allergic reaction to any ingredients in MC2-25 cream or MC2-25 vehicle.
• Start of a new or change of existing non-biologic systemic treatment, within 21 days prior to the Baseline visit.
• Start of a new or change of existing biologic systemic treatment, within 3 months or 5 half-lives (whichever is longest) prior to the Baseline visit.
• Start of a new or change of existing systemic or intravaginal treatment with estrogen containing products, within 21 days prior to the Baseline visit.
• Start of new or change of menstrual care routines within 21 days prior to the Baseline visit.
• Use of emollients on the vulvar region within 3 days prior to the Baseline visit.
• Use of any topical treatment on the vulvar region, within 14 days prior to the Baseline visit.
• Use of any light therapy on the vulvar region, within 28 days prior to the Baseline visit.
• Received a non-marketed or blinded drug within 28 days or 5 half-lives (whichever is longer) prior to the Baseline visit.
• If in the opinion of the investigator, the patient is unlikely to comply with the clinical trial protocol.
• If previously randomized in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MC2-25 cream; MC2-25 cream will be applied daily for 12 weeks	Drug: MC2-25 cream; Topical application
Experimental: MC2-25-vehicle; MC2-25 vehicle will be applied daily for 12 weeks	Drug: MC2-25 vehicle; Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS)	Mean change in weekly Worst Itch Numeric Rating score WI-NRS (as measured on a 11-point numeric rating scale from 0 - 10, where 0 represents no itch and 10 represents worst imaginal itch), calculated as the average of weekly means WI-NRS values from Baseline to Week 12 for MC2-25 cream compared to MC2-25 vehicle.	12 weeks

Collaborators and Investigators

• Sponsor: MC2 Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): May 27, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: MC2-25-C3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No