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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Efficacy and Safety of XT-150 in Osteoarthritis of the Knee
NCTID
NCT04124042
(View at clinicaltrials.gov)
Description
This is a Phase 2 safety and efficacy study of XT-150 in adult participants experiencing moderate to severe pain due to osteoarthritis of the knee.
(Show More)
Development Status
Active
Indication
Osteoarthritis, Knee
Disease Ontology Term
DOID:8398
Compound Name
XT-150
Sponsor
Xalud Therapeutics, Inc.
Funder Type
Industry
Recruitment Status
Completed
Enrollment Count
289
Results Posted
View Results
Therapy Information
Target Gene/Variant
Recombinant IL10
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Overexpression of protective allele/gene
Route of Administration
Intraarticular
Drug Product Type
Plasmid
Target Tissue/Cell
Delivery System
None (naked plasmid)
Vector Type
Editor Type
Dose 1
150ug
Dose 2
450ug (extension study)
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase2
Submit Date
2019-10-09
Completion Date
2022-04-26
Last Update
2025-03-27
Participation Criteria
Eligible Age
45 Years - 85 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
6
Locations
United States,Australia
Regulatory Information
Has US IND
True
FDA Designations
Fast Track
Recent Updates
Resources/Links
Clinical Publications
(Abstract LBA-17) XT-150- A NOVEL IMMUNOMODULATORY GENE THERAPY FOR OSTEOARTHRITIS PAIN IN PHASE 2B DEVELOPMENT
(Abstract) XT-150- A novel immunomodulatory gene therapy for osteoarthritis pain in phase 2b development
News and Press Releases
Xalud Therapeutics Presents Clinical Data on XT-150 in Knee Osteoarthritis at the 2023 Osteoarthritis Research Society International World Congress
Xalud Therapeutics Receives FDA Fast Track Designation for XT-150 for the Treatment of Pain Associated with Osteoarthritis of the Knee
Related NCTID
Phase 1: NCT03477487
Phase 1: NCT03282149
Phase 1: NCT04466410 (Terminated trial for neuropathic pain)