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

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).

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.

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.