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

Torqur AG

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Bimiralisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06319794

TQR-BTOP-101

Details and patient eligibility

About

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

Full 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

Enrollment: 46 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Bimiralisib - 2 weeks treatment

Experimental group

Description:

Topical bimiralisib for 2 weeks

Treatment:

Drug: Bimiralisib

Drug: Bimiralisib

Bimiralisib - 4 weeks treatment

Experimental group

Description:

Topical bimiralisib for 4 weeks

Treatment:

Drug: Bimiralisib

Drug: Bimiralisib