KB803 for Epidermolysis Bullosa
(IOLITE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called KB803, a gene therapy, to help individuals with dystrophic epidermolysis bullosa (DEB), a condition that can cause painful corneal abrasions. The goal is to determine if KB803 is safe and effective compared to a placebo, a non-active treatment. The study includes two groups: one receives KB803, and the other receives a placebo, with participants switching between the two. This trial suits those with a confirmed DEB diagnosis and frequent corneal abrasions. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants a chance to contribute to a promising treatment's journey to market.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot start any new treatments for eye conditions during the run-in period, except for certain eye drops. It's best to discuss your current medications with the study team.
Is there any evidence suggesting that KB803 is likely to be safe for humans?
Research shows that people generally tolerate KB803 well. Several studies have tested this treatment, and no major safety issues have emerged. Some participants experienced side effects, usually mild, such as minor skin reactions. This trial is in a later phase, indicating that earlier phases did not reveal significant safety problems. Treatments typically reach this stage in clinical trials when previous tests have shown them to be reasonably safe.12345
Why do researchers think this study treatment might be promising for epidermolysis bullosa?
Researchers are excited about KB803 for treating Epidermolysis Bullosa because it offers a novel approach compared to existing options like wound care and pain management. KB803 is a gene therapy that aims to correct the underlying genetic defect causing the condition, rather than just addressing the symptoms. This treatment targets the root cause, potentially providing a long-lasting solution and significantly improving the quality of life for patients. Unlike standard treatments that focus on symptom relief, KB803 has the potential to actually repair the skin at a cellular level.
What evidence suggests that KB803 might be an effective treatment for dystrophic epidermolysis bullosa?
Research shows that KB803, which participants in this trial may receive, may help treat repeated eye injuries in people with dystrophic epidermolysis bullosa (DEB). Earlier studies demonstrated that this gene therapy greatly improved vision, from just seeing hand movements to seeing clearly at 20/25 vision. This suggests it could be very effective for eye problems related to DEB. Although specific details about eye injuries aren't provided, these early results are encouraging. In this trial, researchers compare the treatment to a placebo to confirm its benefits.26789
Are You a Good Fit for This Trial?
This trial is for pediatric and adult patients with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB). Specific eligibility criteria are not provided, but typically include a confirmed diagnosis of DEB and experiencing the specific condition the trial aims to treat.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
First Treatment Period
Participants receive weekly ophthalmic administration of KB803 or placebo for 12 weeks
Second Treatment Period
Participants receive the alternative IP (KB803 or placebo) for an additional 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KB803
Trial Overview
The study is testing KB803 against a placebo in a Phase 3 double-blind intra-patient crossover design. This means each patient will receive both the test drug and placebo at different times without knowing which one they're getting, allowing direct comparison within the same individual.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
KB803
Vehicle
Find a Clinic Near You
Who Is Running the Clinical Trial?
Krystal Biotech, Inc.
Lead Sponsor
Citations
1.
ir.krystalbio.com
ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-first-patient-dosed-phase-3-clinicalKrystal Biotech Announces First Patient Dosed in Phase 3 ...
... KB803 for the treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa (DEB) patients. ... data from subjects ...
NCT07016750 | A Study Assessing KB803 Compared to ...
A Study Assessing KB803 Compared to Matching Placebo for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa (IOLITE).
Krystal Biotech Announces First Patient Dosed in Phase 3
Safety and secondary efficacy data, including weekly assessments of eye pain and monthly Epidermolysis Bullosa Eye Disease Index (EB-EDI) ...
4.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/KRYS/pressreleases/35737949/krystal-biotechs-promising-study-on-kb803-for-deb-a-potential-game-changer/Krystal Biotech's Promising Study on KB803 for DEB
It is compared against a placebo to assess its effectiveness in treating DEB-related corneal abrasions. The study follows a randomized, double- ...
5.
stocktitan.net
stocktitan.net/news/KRYS/krystal-biotech-announces-first-patient-dosed-in-phase-3-clinical-snokhibtfw2e.htmlKrystal Biotech Announces First Patient Dosed in Phase 3 ...
Novel gene therapy shows promise for DEB eye complications, advancing to Phase 3 after dramatic vision improvement from hand motion to 20/25 ...
NCT07016750 | A Study Assessing KB803 Compared to ...
KB803-EYE-01 is a Phase 3 double-blind, intra-patient crossover study, to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and ...
A Study Assessing KB803 Compared ...
KB803-EYE-01 is a Phase 3 double-blind, intra-patient crossover study, to evaluate the safety and efficacy of KB803 versus matched placebo in ...
8.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07016750?term=AREA%5BConditionSearch%5D(%22Dystrophic%20Epidermolysis%20Bullosa%22)&rank=2A Study Assessing KB803 Compared to Matching Placebo ...
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...
KB803 for Epidermolysis Bullosa (IOLITE Trial)
KB803-EYE-01 is a Phase 3 double-blind, intra-patient crossover study, to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and ...
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