Table 2. Efficacy and Safety Results From Studies CB-03-01/25 and CB-03-01/26.
| Category | Studies, No. (%) | |||
|---|---|---|---|---|
| CB-03-01/25 | CB-03-01/26 | |||
| Clascoterone (n = 353) | Vehicle (n = 355) | Clascoterone (n = 369) | Vehicle (n = 363) | |
| Efficacy | ||||
| Treatment success at week 12 | 57 (16.1) | 25 (7.0) | 69 (18.7) | 17 (4.7) |
| Adjusted proportions, treatment success at week 12, %a | 18.4 | 9.0 | 20.3 | 6.5 |
| Point estimate (95% CI) | 2.3 (1.4 to 3.8) | NA | 3.7 (2.2 to 6.3) | NA |
| 2-sided P value for treatment effect | <.001 | NA | <.001 | NA |
| Absolute change from baseline in NILC at week 12 | −19.4 | −13.0 | −19.4 | −10.8 |
| Difference, point estimate (95% CI) | −6.4 (−10.3 to −2.6) | NA | −8.6 (−12.3 to −4.9) | NA |
| 2-sided P value for treatment effect | <.001 | NA | <.001 | NA |
| Absolute change from baseline in ILC at week 12 | −19.3 | −15.5 | −20.0 | −12.6 |
| Difference, point estimate (95% CI) | −3.8 (−6.4 to −1.3) | NA | −7.4 (−9.8 to −5.1) | NA |
| 2-sided P value for treatment effect | .003 | NA | <.001 | NA |
| Absolute change in TLC from baseline at week 12 | −39.1 | −28.8 | −40.0 | −23.6 |
| Difference, point estimate (95% CI) | −10.3 (−15.7 to −4.9) | NA | −16.4 (−21.8 to −11.0) | NA |
| 2-sided P value for treatment effect | <.001 | NA | <.001 | NA |
| Change in TLC from baseline at week 12, % | −37.0 | −28.4 | −37.3 | −22.1 |
| Difference, point estimate (95% CI) | −8.6 (−13.9 to −3.3) | NA | −15.2 (−20.5 to −9.9) | NA |
| 2-sided P value for treatment effect | .001 | NA | <.001 | NA |
| Change in NILC from baseline at week 12, % | −30.6 | −21.6 | −29.3 | −15.6 |
| Difference, point estimate (95% CI) | −9.0 (−15.8 to −2.2) | NA | −13.7 (−19.9 to −7.6) | NA |
| 2-sided P value for treatment effect | .009 | NA | <.001 | NA |
| Change in ILC from baseline at week 12, % | −44.8 | −36.5 | −46.9 | −29.6 |
| Difference, point estimate (95% CI) | −8.3 (−14.2 to −2.4) | NA | −17.2 (−22.9 to −11.6) | NA |
| 2-sided P value for treatment effect | .005 | NA | <.001 | NA |
| Safety | ||||
| Patients experiencing ≥1 TEAE | 40 (11.3) | 41 (11.5) | 42 (11.4) | 50 (13.8) |
| Patients experiencing TEAE by severity | ||||
| Mild | 31 (8.8) | 24 (6.8) | 32 (8.7) | 33 (9.1) |
| Moderate | 9 (2.5) | 15 (4.2) | 10 (2.7) | 16 (4.4) |
| Severe | 0 | 2 (0.6) | 0 | 1 (0.3) |
| Patients experiencing TEAEs | ||||
| Serious | 0 | 1 (0.3) | 0 | 1 (0.3) |
| Related to study drug | 4 (1.1) | 9 (2.5) | 8 (2.2) | 13 (3.6) |
| Leading to study drug discontinuation | 3 (0.8) | 4 (1.1) | 2 (0.5) | 8 (2.2) |
| Most frequent TEAEs | ||||
| Nasopharyngitis | 6 (1.7) | 13 (3.7) | 4 (1.1) | 7 (1.9) |
| Headache | 2 (0.6) | 1 (0.3) | 4 (1.1) | 3 (0.8) |
| Oropharyngeal pain | 2 (0.6) | 1 (0.3) | 4 (1.1) | 4 (1.1) |
| Vomiting | 2 (0.6) | 2 (0.6) | 2 (0.5) | 1 (0.3) |
Abbreviations: IGA, Investigator’s Global Assessment; ILC, inflammatory lesion count; NA, not applicable; NILC, noninflammatory lesion count; TEAE, treatment-emergent adverse event; TLC, total lesion count.
a
Adjusted proportion of patients with treatment success defined as at least a 2-point reduction in IGA vs baseline and an IGA score of 0 or 1 at week 12 (logistic regression multiple imputation under missing at random). A logistic regression model with treatment and pooled analysis centers as fixed effects was used to compare the proportion of subjects with at least a 2-point reduction in IGA compared with baseline and an IGA score of 0 or 1 at week 12.