Trial 203

Question 1

Trial design

Answer 1

Phase 2, parallel-group, double-blind, vehicle-controlled RCT of roflumilast FOAM 0.3% for SD

Question 2

trial duration

Answer 2

8 weeks

Question 3

how many sites conducted at?

Answer 3

24 across US and Canada

Question 4

Patient eligibility

Answer 4

1. ≥18 years
2. SD for ≥3 month duration
3. ≥3 IGA score
4. ≥20% BSA affected

Question 5

what meds weren’t allowed?

Answer 5

≥2 weeks before randomization:
1. antifungals
2. corticosteroids
3. calcineurin inhibitors
4. sulfur-based treatments
5. medical devices
6. crisaborole
7. azelaic acid
8. metronidazole

Question 6

randomization

Answer 6

2:1 roflumilast foam 0.3% to vehicle

Question 7

primary endpoint

Answer 7

IGA success at week 8

Question 8

IGA success definition

Answer 8

IGA of clear (0) or almost clear (1) and a 2-grade improvement from baseline (0-4, 0 being clear, 4 being severe)

Question 9

secondary endpoints:

Answer 9

1. IGA success at weeks 2 and 4
2. achievement of erythema score 0 or 1 (0-3, 3 severe)
3. achievement of overall assessment of 0 or 1 (0-3)
4. change from baseline WI-NRS scale (0-10, 0 = no itch, 10 worst)
5. WI-NRS success

Question 10

WI-NRS success

Answer 10

achievement of a ≥4 point improvement from baseline

Question 11

safety assessment

Answer 11

AEs, labs, vitals, PHQ-8, C-SSRS

Question 12

Sample size of X needed to reach 90% power to detect a response of ____%

Answer 12

184 participants, ≥58.5% response

Question 13

mITT population included all randomized patients except those who

Answer 13

missed week 8 IGA assessment due to COVID-19

Question 14

how many patients were randomized?

Answer 14

226 (154 and 72 active and experiemntal)

Question 15

how many patients DCd due to AEs?

Answer 15

2 (1.3%) roflumilast, 1 (1.4%) placebo

Question 16

how many patients DCd due to covid?

Answer 16

2 (1.3%)

Question 17

how many patients achieved IGA success?

Answer 17

104 (73.8%) rofl vs 27 (40.9%) placebo

Question 18

conclusions: rofl found to treat

Answer 18

erythema, scaling, and itch caused by SD

Question 19

conclusions: rofl patients had statstically higher rates of IGA vs vehicle at week

Answer 19

2

Question 20

What was the long-term safety trial in 203?

Answer 20

Open-label trial conducted in patients ≥12 with at least moderate SD who successfully completed a prior roflumilast foam trial and in patients naive to rofl and its vehicle

Question 21

primary endpoints of the safety trial?

Answer 21

occurence of AEs and SAEs

Question 22

secondary endpoints of the safety trial

Answer 22

IGA

Question 23

What percentage of patients int he safety trial experienced a TEAE?

Answer 23

32.5%

Question 24

what percentage of the TEAEs in the safety trial were treatment related?

Answer 24

5.5%how

Question 25

what percentage of patients experienced a serious AE?

Answer 25

1.8%, but not treatment related

Question 26

what percent of patients had no evidence of irritation at each visit?

Answer 26

≥96%

Question 27

what percentage of patients reported no or mild sensation at each visit?

Answer 27

≥95.2%

Question 28

most patients with hypo-/hyperpigmentation at baseline experienced a full resolution by week

Answer 28

24

Question 29

how many patients had hypopigmentation at baseline? how many experienced full resolution at week 52?

Answer 29

23.9% at baseline, 72.7% full resolution

Question 30

How many patients had hyperpigmentation at baseline? how many experienced full resolution at week 52?

Answer 30

15.2% at baseline, 85.7% full resolution

Question 31

what percentage of patients achieved IGA status of clear or almost clear at the first follow-up in the safety trial? what about at week 24/

Answer 31

55.7%, 76.2%