Evaluating Bimiralisib Gel for Actinic Keratosis Treatment

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

This study is testing a new gel called bimiralisib to see if it can safely treat actinic keratosis on the face, scalp, and back of hands.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Torqur (Industry-sponsored)
• Drugs / interventions: methotrexate
• Locations: 2 sites (Basel and 1 other locations)
• Trial ID: NCT06319794 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of bimiralisib gel in treating actinic keratosis on the face, scalp, and back of hands. It is a multi-center, randomized, open-label study where participants will be assigned to receive either a 2-week or 4-week treatment with the gel. The study includes a screening period of up to 30 days, followed by the treatment phase and a 4-week follow-up. Participants will be monitored for the effectiveness of the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with stable actinic keratosis lesions on their face, scalp, or back of hands.

Not a fit: Patients with unstable actinic keratosis or those who do not meet the age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from actinic keratosis.

How similar studies have performed: Other studies have shown promise with similar topical treatments for actinic keratosis, suggesting potential for success in this approach.

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

Where this trial is running

Basel and 1 other locations

• University Hospital Basel / Department of Dermatology — Basel, Switzerland (Recruiting)
• CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology — Lausanne, Switzerland (Recruiting)

Study contacts

• Study coordinator: Natasa Cmiljanovic

Conditions Actinic Keratosis