Trial 203 Flashcards
Trial design
Phase 2, parallel-group, double-blind, vehicle-controlled RCT of roflumilast FOAM 0.3% for SD
trial duration
8 weeks
how many sites conducted at?
24 across US and Canada
Patient eligibility
- ≥18 years
- SD for ≥3 month duration
- ≥3 IGA score
- ≥20% BSA affected
what meds weren’t allowed?
≥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
randomization
2:1 roflumilast foam 0.3% to vehicle
primary endpoint
IGA success at week 8
IGA success definition
IGA of clear (0) or almost clear (1) and a 2-grade improvement from baseline (0-4, 0 being clear, 4 being severe)
secondary endpoints:
- IGA success at weeks 2 and 4
- achievement of erythema score 0 or 1 (0-3, 3 severe)
- achievement of overall assessment of 0 or 1 (0-3)
- change from baseline WI-NRS scale (0-10, 0 = no itch, 10 worst)
- WI-NRS success
WI-NRS success
achievement of a ≥4 point improvement from baseline
safety assessment
AEs, labs, vitals, PHQ-8, C-SSRS
Sample size of X needed to reach 90% power to detect a response of ____%
184 participants, ≥58.5% response
mITT population included all randomized patients except those who
missed week 8 IGA assessment due to COVID-19
how many patients were randomized?
226 (154 and 72 active and experiemntal)
how many patients DCd due to AEs?
2 (1.3%) roflumilast, 1 (1.4%) placebo
how many patients DCd due to covid?
2 (1.3%)
how many patients achieved IGA success?
104 (73.8%) rofl vs 27 (40.9%) placebo
conclusions: rofl found to treat
erythema, scaling, and itch caused by SD
conclusions: rofl patients had statstically higher rates of IGA vs vehicle at week
2
What was the long-term safety trial in 203?
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
primary endpoints of the safety trial?
occurence of AEs and SAEs
secondary endpoints of the safety trial
IGA
What percentage of patients int he safety trial experienced a TEAE?
32.5%
what percentage of the TEAEs in the safety trial were treatment related?
5.5%how
what percentage of patients experienced a serious AE?
1.8%, but not treatment related
what percent of patients had no evidence of irritation at each visit?
≥96%
what percentage of patients reported no or mild sensation at each visit?
≥95.2%
most patients with hypo-/hyperpigmentation at baseline experienced a full resolution by week
24
how many patients had hypopigmentation at baseline? how many experienced full resolution at week 52?
23.9% at baseline, 72.7% full resolution
How many patients had hyperpigmentation at baseline? how many experienced full resolution at week 52?
15.2% at baseline, 85.7% full resolution
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/
55.7%, 76.2%
