Clinical trial NCT06319794: Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis
Official title: A Randomized Phase 2 Proof-of-Concept Study to Evaluate the Efficacy and Safety of Topical Bimiralisib Application in Participants Suffering From Actinic Keratosis on the Face and/or Scalp and/or Back of Hands Over a 2 and 4-week Treatment Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: TORQUR
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Primary outcomes:
measure: Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1
timeFrame: Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B)
Secondary outcomes:
measure: Proportion of participants with partial or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arms)
timeFrame: Day 15 (Treatment Arm A), Day 29 (Treatment Arm B)
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: From first application of bimiralisib until 28 days after the last application
measure: Incidence of local skin reactions
timeFrame: From first application of bimiralisib until 28 days after the last application
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel / Department of Dermatology
city: Lausanne
country: Switzerland
facility: CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology
Study officials:
References: