Efficacy and Safety of XT-150 in Osteoarthritis of the Knee
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 270
Summary
- Conditions
- Osteoarthritis (Knee)
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, blinded, placebo-controlled, study of pain due to OA of the kneeMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 85 years
- Gender
- Both males and females
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. Baseline confirmation of study eligibility will be completed the day before or day of study drug administration. Study drug will be administered by intr...
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. Baseline confirmation of study eligibility will be completed the day before or day of study drug administration. Study drug will be administered by intra-articular (IA) injection into the joint space of the knee. Up to 270 participants will be randomly enrolled into 1 of 3 treatment groups (90 participants/ group). Treatment Groups: Placebo (1 mL) Low dose XT-150 (1 mL) High dose XT-150 (1 mL) The study will be conducted in 2 stages, A and B: A. Placebo-controlled for 6 months B. Continued follow up for 6 months with the option of receiving one of two doses of XT-150 injection to the index knee. Final assessments will be 12 months after the first IA dose.
Tracking Information
- NCT #
- NCT04124042
- Collaborators
- Not Provided
- Investigators
- Study Chair: Stephen D Collins, MD Xalud Therapeutics, Inc.
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