A Double-Blind, Placebo-Controlled Assessment of the Tolerability and Efficacy of XT-150 for the Treatment of Moderate to Severe Pain Due to Osteoarthritis of the Knee

Who is this study for? Older adult patients with Knee Osteoarthritis
What treatments are being studied? XT-150 Plasmid DNA
Status: Completed
Location: See all (6) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
View:

• Symptomatic disease due to osteoarthritis, defined as a WOMAC Pain score ≥ 8 (worst possible = 20)

• Focused Analgesia Selection Test will be used to determine whether patients can report pain with sufficient consistency to enter the clinical trial

• Males and females between 45 and 85 years of age, inclusive

• Kellgren-Lawrence grading of 2 or 3 within the last 6 months

• Stable analgesic regimen during the 4 weeks prior to enrollment

• In the judgment of the Investigator, acceptable general medical condition

• Life expectancy \>6 months

• Male and female participants who are heterosexually active and not surgically sterile must agree to use effective contraception, including abstinence, for the duration of the study

• Have suitable knee joint anatomy for intra-articular injection

⁃ Willing and able to return for the follow-up (FU) visits

⁃ Able to read and understand study instructions, and willing and able to comply with all study procedures

Locations
United States
California
eStudySite
La Mesa
Neurovations (Napa Pain Institute)
Napa
Source Healthcare
Santa Monica
North Carolina
Carolinas Clinical Research Institute
Winston-salem
Other Locations
Australia
University of Adelaide in collaboration with CMAX Clinical Research Pty Ltd
Adelaide
Alfred Health
Melbourne
Time Frame
Start Date: 2020-02-14
Completion Date: 2022-04-26
Participants
Target number of participants: 289
Treatments
Experimental: Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
Low dose active in Stage A and Stage B
Experimental: Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
Low dose active in Stage A, high dose active in Stage B
Experimental: Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
High dose active in Stage A, low dose active in Stage B
Experimental: Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
Placebo_comparator: Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
Placebo_comparator: Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
Related Therapeutic Areas
Sponsors
Leads: Xalud Therapeutics, Inc.

This content was sourced from clinicaltrials.gov