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Compares treatment options for Dystrophic Epidermolysis Bullosa
Official title A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa
ClinicalTrials.gov ID: NCT07016750
What this study is testing
What is KB803?
KB803 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for dystrophic epidermolysis bullosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- KB803-EYE-01 is a Phase 3 double-blind, randomized, placebo-controlled, crossover study to evaluate the safety and efficacy of KB803 versus matched placebo in pediatric and adult subjects with recurrent corneal abrasions due to dystrophic epidermolysis bullosa (DEB).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- The subject and/or their parent/legal guardian must provide informed consent/assent and must be able to and willing to follow study procedures and...
- Age 6 months or older at time of informed consent/assent.
- Confirmed diagnosis of DEB with a mutation in the COL7A1 gene.
- Meets minimum corneal abrasion symptom frequency in the NHS study.
You likely can't join if
- Initiation of any new treatment regimen or change in treatment for ocular disease during the run-in period except for preservative free topical...
- Treatment with an investigational agent or off-label ophthalmic use of an approved product during the run-in period or planned use during the study...
- Any condition that, in the opinion of the Investigator, would impact the completion of all study-related assessments, interfere with the...
- Women who are pregnant or nursing.
- Subject who is unwilling to comply with contraception requirements per protocol.
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Rancho Santa Margarita, California, United States
- Coral Gables, Florida, United States
- Worcester, Massachusetts, United States
- Cincinnati, Ohio, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rancho Santa Margarita, California, United States; Coral Gables, Florida, United States; Worcester, Massachusetts, United States; Cincinnati, Ohio, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.