EASE Trial Design
Primary End Point
Open-Label, Follow-Up Study
FILSUVEZ Results

EASE Trial Design

FILSUVEZ was studied in the largest clinical trial of people with dystrophic or junctional epidermolysis bullosa

A clinical trial called EASE tested how safe and effective FILSUVEZ was in treating skin wounds in people with DEB or JEB. The study enrolled a total of 223 children and adults with DEB and JEB who were between 6 months and 81 years of age (with a median age of 12 years).

During the 90-day double-blind phase of the trial, patients treated their wounds with either FILSUVEZ or placebo gel. Afterward, participants from both groups were able to join the optional 2-year, open-label, follow-up study, during which all patients used FILSUVEZ.

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90-day

double-blind,* phase 3 study

Target wounds were measured and treated
with FILSUVEZ or placebo

109 participants

FILSUVEZ

plus standard-of-care wound dressing^‡

114 participants

Placebo Gel

plus standard-of-care wound dressing^‡

Day 0

Day 45

Primary end point results
were measured

Day 90

Day 0 of follow-up

2-year

open-label,^† follow-up study

All patients used FILSUVEZ, and it was applied to all wounds

205 participants

FILSUVEZ

plus standard-of-care wound dressing^‡

Month 12

Year 2

End of
follow-up

*Double-blind refers to a type of study in which neither the participants nor the researchers know which study group they are in.

^†Open-label refers to a type of study in which the participants and the researchers know which treatment they are given. All participants have the same visits, tests, and check-ins.

^‡Standard-of-care dressings were nonadhesive dressings of physician or patient choice.

Primary End Point

FILSUVEZ was effective in treating dystrophic and junctional epidermolysis bullosa wounds in the landmark EASE trial

In the 90-day, double-blind phase of the EASE trial, researchers measured how well FILSUVEZ helped wounds heal by selecting one wound per participant to track during the study. Primary end point results showed that more than 40% of participants who were treated with FILSUVEZ experienced complete wound closure in approximately one and a half months (45 days) compared with 29% of people using placebo gel.

Patients using FILSUVEZ

Patients using placebo gel (RR, 1.44; 95% CI, 1.01-2.05; P=.013)

within

1.5

months

Healing may take time. Continue treatment as directed and talk with your doctor about expectations, even if you don’t see results right away.

Complete wound closure criteria:

A target wound selected in advance had to be 100% closed by Day 45 for treatment to be considered successful
A wound was considered completely closed when the skin had fully healed over it and there was no fluid or drainage coming from the wound
Wounds that did not meet the definition of 100% closure by Day 45 were not counted in the primary end point for FILSUVEZ, even if there was noticeable healing

CI, confidence interval; RR, relative risk.

Double-Blind, Phase 3 Study Open-Label, Follow-Up Study

Healing continued beyond 90 days

After the 90-day trial period, patients had the option to remain in the trial for another 2 years in the open-label, follow-up study. Patients who continued in the trial saw lasting results over time.

The average area of skin covered by wounds decreased by 36% in the first 3 months. By 2 years, it reduced by 50%^§

Full-body silhouette with multiple shaded areas across the body

Full-body silhouette with fewer shaded areas across the body

Full-body silhouette with the least amount of shaded areas across the body

Start of trial

90 days

36% reduction in the average area of skin covered by wounds at Day 90 among patients using FILSUVEZ in the double-blind phase.^‖

The mean percentage of body surface area affected by wounds at Day 90 was 7.4% (-4.3% absolute change from baseline).

2 years

50% reduction after 2 years of treatment among patients who continued using FILSUVEZ in the open-label, follow-up study.^‖

The mean percentage of body surface area affected by wounds decreased from 12.1% at baseline to 6.1% at study completion.

^§These findings are exploratory, meaning researchers are studying them to learn more and help guide future research. Talk with your doctor about what these results may mean for you and your treatment goals.

^‖Because other key study results were not statistically significant, these findings should be interpreted with caution.

FILSUVEZ Results

See the results after treatment with FILSUVEZ