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

• Status: Recruiting
• Trial end date: 2024-06-10
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MC2 Therapeutics

Criteria

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.