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

Actinic Keratosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319794
• Other study ID #: TQR-BTOP-101
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: TORQUR
• Contact: Natasa Cmiljanovic
• Phone: +41(0)765288970
• Email: natasa.cmiljanovic[@]swissrockets.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Bimiralisib
Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 2 weeks
• Bimiralisib
Participants will be instructed to self-apply topical bimiralisib gel on the treatment area once daily for 4 weeks

Locations

Country	Name	City	State
Switzerland	University Hospital Basel / Department of Dermatology	Basel
Switzerland	CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
TORQUR

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Proportion of participants with partial (75% reduction in lesions) or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arm)	Day 15 (Treatment Arm A), Day 29 (Treatment Arm B)
Secondary	Incidence of Treatment-Emergent Adverse Events	Safety endpoint assessed by treatment-emergent adverse events (including laboratory adverse events and vital signs)	From first application of bimiralisib until 28 days after the last application
Secondary	Incidence of local skin reactions	Tolerability endpoint assessed by Investigator for specific local skin reactions using 4-point clinical scales for irritation, stinging/burning and pruritus.; Scales from 0 (no signs) to 3 (severe)	From first application of bimiralisib until 28 days after the last application