Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis

Trial Title: Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis

NCT ID: NCT06319794

Condition: Actinic Keratosis

Conditions: Official terms:
Keratosis, Actinic
Keratosis

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Bimiralisib
Description: Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks
Arm group label: Bimiralisib - 2 weeks treatment

Intervention type: Drug
Intervention name: Bimiralisib
Description: Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 4 weeks
Arm group label: Bimiralisib - 4 weeks treatment

Summary: The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands

Detailed description: This is a multi-center, randomized, open label, parallel group study. The study products will be applied to the target lesions for a duration of 2 or 4 weeks of treatment. The study consists of the following periods: - Screening (up to 30 days) - Treatment (2 or 4 weeks) - Follow-Up (4 weeks) Participants will be randomized to one of two groups (1:1): - Arm A: Topical bimiralisib gel treatment for 2 weeks - Arm B: Topical bimiralisib gel treatment for 4 weeks

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: - Must be of at least 50 years of age, at the time of signing the informed consent. - Have a clinical diagnosis of stable, clinically typical actinic keratosis. - Have at least 3 actinic keratosis lesions contained within contiguous treatment regions of face and/or scalp and/or back of hands. - Must agree not to use any product on the treatment area during the entire course of study except for Investigator-approved cleanser, sunscreen, wash, and non-medicated makeup. - Must be willing to comply with sun avoidance measures for all exposed areas including use of Investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use. - Must be in good general health (ECOG 0-1) - Participants of reproductive potential must agree to use double effective contraception from screening until 90 days after discontinuing study treatment. - Female participants who had a menstrual cycle within 2 years prior to screening must have a negative serum pregnancy test at screening and a negative urine pregnancy test on their first treatment day. - Must be capable of giving signed informed consent Key Exclusion Criteria: - Known or suspected hypersensitivity to any of the excipients of bimiralisib gel. - Clinically atypical and/or rapidly changing actinic keratosis lesions in the treatment area. - Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease. - Participation in any clinical research study within 30 days of the Baseline Visit. - Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy, cryotherapy) within 4 weeks of the Baseline visit and within 2 cm of the selected treatment area. - Use of sun lamps, tanning beds, and tanning booths during the 4 weeks prior to the Baseline Visit or planned use during the study. - Use of any retinoids within 90 days of the Baseline Visit, or glucocorticosteroids, methotrexate or other anti-metabolites or nicotinamide within 28 days of the Baseline Visit. - Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit. - Any other malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not in the treatment area that were treated with curative intent and are without recurrence. - Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Basel / Department of Dermatology

Address:
City: Basel
Country: Switzerland

Status: Recruiting

Contact:
Last name: Alexander Navarini

Facility:
Name: CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology

Address:
City: Lausanne
Country: Switzerland

Status: Recruiting

Contact:
Last name: Olivier Gaide

Start date: April 2, 2024

Completion date: December 2024

Lead sponsor:
Agency: TORQUR
Agency class: Industry

Source: TORQUR

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06319794