Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

Study Overview
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Brief Summary
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This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.

Detailed Description
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This Phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of VDA-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. The first 40 eligible subjects will be enrolled into Cohort 1 (Part A). Cohort 1 subjects will be assigned to receive approximately 200 mg of 10% VDA-1102 twice-daily (BID). Once approximately 40 subjects have been enrolled in Cohort 1, Cohort 1 will be closed to enrollment and Cohort 2 (Part B) will be opened for enrollment. Cohort 2 subjects will be assigned to receive approximately 200 mg of 20% VDA-1102 once-daily (QD). Once approximately 40 subjects have been enrolled in Cohort 2, an additional 70 subjects will be randomly assigned to Cohort 1 or Cohort 2 (Part C) in a 1:1 ratio. To qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (AK) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the Treatment Field).

Official Title
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Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: 10% VDA-1102
* Drug: 20% VDA-1102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp Exclusion Criteria: Subject has no clinically significant findings at Baseline Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem Subject has at any time been given a diagnosis or treatment associated with immunosuppression Subject has received VDA-1102 in the past

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 3-part, open-label, multi-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>10% VDA-1102 | Drug: 10% VDA-1102<br>* 200 mg twice-daily for 12 weeks<br>* Other names: 10% VDA-1102 topical ointment;|
| Experimental: Cohort 2<br>20% VDA-1102 | Drug: 20% VDA-1102<br>* 200 mg once-daily for 12 weeks<br>* Other names: 20% VDA-1102 topical ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance Rate | Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm | Week 16 | 
| Complete Facial Clearance Rate | Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Clearance | Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of AK lesions in the selected area of subjects of subjects in each treatment arm | 16 weeks | 
| Partial Facial Clearance | Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of facial AK lesions in the selected area of subjects in each treatment arm | 16 weeks | 
| Lesion Number Reduction | Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm | 16 weeks | 
| Lesion Number Reduction on Face | Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actinic keratosis, efficacy, safety, VDA-1102