ATX-101 for Post-surgical Pain Following Total Knee Arthroplasty

Sponsor

Allay Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05260008

Collaborator

(none)

345

Enrollment

Location

Arms

12.7

Anticipated Duration (Months)

27.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2B randomized, double blind, placebo and active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Acute Postoperative Pain	Drug: ATX-101 Drug: ATX-101 Drug: Placebo Drug: bupivacaine hydrochloride without epinephrine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

345 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a Phase 2B, randomized, double blind, placebo, and active comparator multicenter trial in participants undergoing total knee arthroplasty.This is a Phase 2B, randomized, double blind, placebo, and active comparator multicenter trial in participants undergoing total knee arthroplasty.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2B, Randomized, Double Blind, Placebo and Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty

Actual Study Start Date :

Jun 7, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATX-101 Dose A ATX-101 Dose A	Drug: ATX-101 ATX-101 (bupivacaine) implant, one-time administration into the surgical site
Experimental: ATX-101 Dose B ATX-101 Dose B	Drug: ATX-101 ATX-101 (bupivacaine) implant, one-time administration into the surgical site
Placebo Comparator: saline saline placebo via local infiltration	Drug: Placebo saline placebo (0.9%) sodium chloride via local infiltration
Active Comparator: bupivacaine hydrochloride bupivacaine hydrochloride without epinephrine via local infiltration	Drug: bupivacaine hydrochloride without epinephrine bupivacaine hydrochloride (125 mg) without epinephrine via local infiltration

Outcome Measures

Primary Outcome Measures

Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity. [from 30 minutes post-surgery through hour 168]

Secondary Outcome Measures

Area under the curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of pain intensity. [from 30 Minutes post-surgery through Hour 168, Hour 240, and Hour 336]
Percentage of subjects who remain opioid free. [from Hour 72 post-surgery through Day 30]
Total post-surgical consumption of opioid medications. [from surgical closure through Day 30]
Area under the curve for the Numeric Rating Scale at Rest (NRS-R) of pain intensity. [from surgical closure for each 24-hour period through Hour 336]
Percentage of subject who remain opioid free. [Surgical Closure to Day 30]
Total post-surgical use of rescue opioid medications. [Surgical Closure to Day 30]
Time to first postsurgical use of rescue opioid medication. [Surgical Closure to Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis.
Scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted).
American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2 or 3.

Exclusion Criteria:

Has a planned concurrent surgical procedure.
Has had any previous arthroplasty, unicompartmental knee arthroplasty or total knee arthroplasty in the study knee or previous arthroplasty, unicompartmental knee arthroplasty, or total knee arthroplasty in the contralateral knee within 6 months prior to screening.
Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee.
Immunocompromised or has a known history of Hepatitis B, human immunodeficiency virus (HIV), or Hepatitis C.
Routinely take opioid analgesics and are expected to require opioid analgesics in the postsurgical period that is not strictly related to the trial.
Unable to abstain from opioid use for knee pain within 14 days of surgery.
Has been administered systemic steroids within 14 days prior to surgery.
Has been administered any local anesthetic within 5 days prior to the scheduled surgery.
Screening electrocardiogram (ECG) with significant abnormalities associated with significant heart disease.
Has a contraindication or a known suspected history of allergy, hypersensitivity or idiosyncratic reaction to trial medications.
Has uncontrolled depression, anxiety, psychiatric, or neurological disorder that might interfere with trial study assessments.
Has a medical condition or receiving medication such that, in the opinion of the investigator, participating in the trial would pose a health risk to the subject or might interfere with the study outcome.
Has a known or suspected history of drug or alcohol abuse. A subject with a history of alcohol use disorder that has ≥10 years sobriety will be permitted.
Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine.
Has a Body Mass Index (BMI) ≥40 kg/m2.