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

NCT06319794 | Completed Phase 2

• 1 other identifier: TQR-BTOP-101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1

  Improvement from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1 (on a 0-4 scale where 0 is complete clearance and 4 is no improvement)

  Baseline, Day 43 (Treatment Arm A), Day 57 (Treatment Arm B)

Secondary Outcomes (3)

• 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)

  Day 15 (Treatment Arm A), Day 29 (Treatment Arm B)

• Incidence of Treatment-Emergent Adverse Events

  From first application of bimiralisib until 28 days after the last application

• Incidence of local skin reactions

  From first application of bimiralisib until 28 days after the last application

Study Arms (2)

Bimiralisib - 2 weeks treatment

EXPERIMENTAL

Topical bimiralisib for 2 weeks

Drug: Bimiralisib

Bimiralisib - 4 weeks treatment

EXPERIMENTAL

Topical bimiralisib for 4 weeks

Drug: Bimiralisib

Interventions

Bimiralisib DRUG

Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks

Bimiralisib - 2 weeks treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TORQUR: lead

Study Sites (2)

University Hospital Basel / Department of Dermatology

Basel, Switzerland

Location

CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 20, 2024
• Study Start: April 2, 2024
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)