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Clinical Trials in the USA / NCT06452316
Recruiting Phase 1

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency

NCT06452316 · tracked via the Priya Life Science USA tracker
Sponsor
Claris Biotherapeutics, Inc.
Phase
Phase 1
Started
2024-05-15
Last updated
2026-08-13

Condition(s) studied

Limbal Stem Cell Deficiency

Investigational drug(s) / intervention(s)

CSB-001 Ophthalmic Solution 0.1%

CSB-001 Ophthalmic Solution 0.1%: CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Study summary

This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Have an area of the central 5 mm zone of cornea affected, presence of at least one clinical sign observed by slit-lamp examination with white light and/or cobalt blue light, fluorescein, and a Wratten filter, and at least one clinical sign observed with AS-OCT. * If dosing with Acthar at time of Screening Visit, must have a history of stable dosing for approximately 8 weeks, plan to maintain the same Acthar treatment dose and regimen, and have demonstrated little to no improvement in severity of LSCD. * Sponsor written confirmation of qualifying LSCD diagnosis. * Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation. Exclusion Criteria: * Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye. * Ocular surgery within 30 days of Day 0 where investigator assesses that healing is not considered complete/stable. * Planned ocular surgery on or before Week 20 visit. * Presence or history of any ocular or systemic disorder, condition, or procedure that might hinder the efficacy of the study treatment or its evaluation, or could interfere with the interpretation of study results, in the opinion of the investigator. Note: Other inclusion/exclusion criteria apply.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Loma Linda University Eye Institute Loma Linda California Recruiting
Midwest Cornea Associates, LLC Carmel Indiana Recruiting
Francis Price Jr, MD Indianapolis Indiana Recruiting
Minnesota Eye Consultants Minnetonka Minnesota Recruiting
Legacy Devers Eye Institute Portland Oregon Recruiting
Stuart A. Terry, MD PA San Antonio Texas Recruiting

More Claris Biotherapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06452316 on ClinicalTrials.gov ↗ ← All trials in the USA