STRATUM

Question 1

STRATUM trial description

Answer 1

Phase 3, parallel-group, DB, vehicle-controlled, 8 week RCT of QD roflumilast FOAM 0.3% for treatment of SD

Question 2

where was STRATUM conducted?

Answer 2

50 sites across US and CA

Question 3

who were eligible patients/

Answer 3

1. ≥9 years with SD
2. ≥3 month duration SD
3. IGA score ≥3
4. affects ≤20% BSA
5. erythema/scaling scores of at least moderate (≥2, 0-4)

Question 4

randomization for patients

Answer 4

2:1

Question 5

Primary endpoints

Answer 5

IGA success (0/1+≥2-grade improvement from baseline) at week 8

Question 6

sample size of X needed for ~90% power to detect a Y% difference

Answer 6

450, 25% difference

Question 6

Secondary endpoints

Answer 6

1. IGA success at weeks 2 and 4
2. Erythema score of 0 (0-3)+2-grade improvement from baseline at w8
3. scaling score of 0 (0-3)+2-grade improvement at week 8
4. % change in daily WI-NRS from baseline (0-10, itch)
5. Scalpdex score and dermatology life quality index

Question 7

how many patients in STRATUM?

Answer 7

N=457, 304 API 153 vehicle

Question 8

how many patients DCd?

Answer 8

9.4% (43)

Question 9

primary endpoint results

Answer 9

statistically significantly more rolf-treated patients (79.5%) than vehicle (58%) met primary endpoint at week 8

Question 10

Statistically significant differences in percentages of patients with IGA Success favored roflumilast at Week 2

Answer 10

roflumilast: 43.0%; vehicle: 25.7%; p<0.001 week 2; roflumilast: 73.1%; vehicle: 47.1%; p<0.001 week 4

Question 11

More patients treated with roflumilast than vehicle had IGA of 0 (Clear) at Week 8

Answer 11

50.6% vs. 27.7%, respectively; p<0.001

Question 12

Percentage of patients achieving IGA Success consistent in adolescent patients (age 9-17 years) at Week 8

Answer 12

roflumilast: 76.5%; vehicle: 46.7%

Question 13

X of patients in either treatment group reported treatment-related TEAEs

Answer 13

3.3%

Question 14

Among 70 roflumilast-treated patients reporting a TEAE, the worst reported severity was mild or moderate for X and severe for Y; none was considered related to treatment

Answer 14

66 (94.3%), 4 (5.7%, none were treatment-related)

Question 15

At baseline, Weeks 4 and 8, X of patients had no evidence of irritation on investigator-rated assessments and Y of patients reported a score of 0 (no sensation) or 1 (slight warm, tingling sensation; not really bothersome) on patient-rated tolerability

Answer 15

≥98.9%, ≥92.4%

Question 16

whichclinically meaningful differences in clinical laboratory assessments or vital signs observed, and assessments of depression, suicidal ideation, and behavior did not indicate any safety concerns

Answer 16

none

Question 17

Hypo- and hyperpigmentation more common in non-White patients than White patients at baseline

Answer 17

(9.9% vs. 2.5% and 9.9% vs. 1.7%, respectively)

Question 18

Pigmentary findings improved in both treatment groups during the trial; at Week 8, X and Y of patients with baseline hypo- and hyperpigmentation, respectively experienced full resolution

Answer 18

64.7%; 46.2%

Question 19

At Week X, new instances of hypopigmentation (n=0) and hyperpigmentation (n=6) were uncommon

Answer 19

8

Question 20

Conclusions: Once-daily treatment with roflumilast foam, 0.3% resulted in significant and clinically meaningful improvements in key signs and symptoms of seborrheic dermatitis and was well tolerated in patients as young as X years of age

Answer 20

9

Question 21

Conclusions: Significantly more roflumilast-treated patients than vehicle-treated patients achieved the primary endpoint of IGA Success at Week 8

Answer 21

80% of roflumilast-treated patients achieving IGA Success and >50% achieving clearance

Question 22

Conclusions: Roflumilast-treated patients had significant reductions in what measurement by 48 hours after first application

Answer 22

WI-NRS