Clinical Trials on Clascoterone Cream

What is the study design of the pivotal phase 3 studies CB-03-01/25 and CB-03-01/26?

• Single-centre, randomised, single-blind, placebo-controlled, parallel-group phase 3 comparison studies

• Single-centre, randomised, double-blind, placebo-controlled, parallel-group phase 3 comparison studies

• Multi-centre, randomised, single-blind, vehicle-controlled, parallel-group phase 3 comparison studies

• Multi-centre, randomised, double-blind, vehicle-controlled, parallel-group phase 3 comparison studies

Which of the following is true about Investigator's Global Assessment Scale (IGA)?

• It is a patient-reported outcome measure evaluating satisfaction with acne treatment

• It ranges from 0 (clear) to 4 (severe) and is used to assess acne severity

• It measures only the number of non-inflammatory lesions on the face

• Treatment success requires a 1-grade improvement from baseline regardless of final score

How is treatment success defined in the pivotal phase 3 studies?

• ≥1-point reduction in IGA score and IGA score of 0 ("clear")

• No new lesions for 1 month

• ≥2-point reduction in IGA score and a score of 0 ("clear") or 1 ("almost clear")

• Complete resolution of inflammatory lesions

In the pivotal phase 3 studies CB-03-01/25 and CB-03-01/26, success rates in subjects receiving WINLEVI cream 1% versus vehicle cream were significantly better from baseline based on which of the following?

• IGA success and noninflammatory lesion reduction

• Inflammatory lesion reduction and noninflammatory lesion reduction

• IGA success and inflammatory lesion reduction

• IGA success, noninflammatory lesion reduction, and inflammatory lesion reduction

What were the most common treatment emergent adverse events (TEAEs) in the pivotal WINLEVI cream 1% studies CB-03-01/25 and CB-03-01/26?

• Application-site pain, oropharyngeal pain, and application-site dryness

• Acne, headache, and eye irritation

• Application-site pain, nasopharyngitis, and acne

• Nasopharyngitis, headache, and oropharyngeal pain

Which of the following are the top 2 local skin reactions (LSRs) observed for both pivotal phase 3 studies CB-03-01/25 and CB-03-01/26?

• Erythema and scaling/dryness

• Scaling/dryness and pruritus

• Erythema and pruritus

• Stinging/burning and scaling/dryness

Which of the following is true of the patient demographics in the pooled analysis paper?

• Overall, 709 patients were treated with WINLEVI Cream 1% and 712 patients to vehicle

• Among patients treated with WINLEVI Cream 1%, around 40% were male

• At baseline, the patients' IGA score were moderate (3) to severe (4)

• All of the above

What are the 3 coprimary efficacy endpoints of the pooled analysis paper?

• Proportion of patients achieving IGA 0/1 at week 12, absolute change from baseline in noninflammatory lesion count (NILC) and inflammatory lesion count (ILC) at week 12

• Proportion of patients achieving IGA 0/1 at week 12, percent change from baseline in NILC and ILC at week 12

• Proportion of patients achieving IGA success at week 12, absolute change from baseline in NILC and ILC at week 12

• Proportion of patients achieving IGA success at week 12, percent change from baseline in NILC and ILC at week 12

In the pooled analysis study, success rates in subjects 12 years of age and older receiving WINLEVI cream 1% versus vehicle cream were significantly better from baseline based on which of the following?

• IGA success, noninflammatory lesion reduction, and inflammatory lesion reduction

• IGA success and noninflammatory lesion reduction

• Inflammatory lesion reduction and noninflammatory lesion reduction

• IGA success and inflammatory lesion reduction

Which of the following is true of the treatment emergent adverse events (TEAEs) data in the pooled analysis study? Select all that apply

• Incidence of TEAEs were similar between WINLEVI cream 1% and vehicle-treated groups

• Incidences of TEAEs was low

• Most were mild or moderate in severity

• No serious TEAEs were reported in WINLEVI cream 1% treated-group but 2 vehicle-treated patients experienced serious TEAEs