Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain

May 11, 2026 updated by: Saol Therapeutics Inc

A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee

A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the treatment of knee pain associated with mild to moderate osteoarthritis.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kiki Diorgu, M.D.
  • Phone Number: 770-274-2827
  • Email: info@saolrx.com

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92111
        • Recruiting
        • Innovative Pain Treatment Solutions
        • Contact:
          • Krishnan Chakravarthy, M.D., Ph.D.
          • Phone Number: 770-274-0827
          • Email: info@saolrx.com
        • Principal Investigator:
          • Krishnan Chakravarthy, M.D., Ph.D.
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Recruiting
        • DBPS Research, LLC
        • Principal Investigator:
          • Scott Bainbridge, M.D.
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20006
        • Recruiting
        • International Spine, Pain & Performance Center
        • Principal Investigator:
          • Mehul Desai, M.D.
        • Contact:
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Prime Medical Research
        • Contact:
        • Principal Investigator:
          • Miguel Telleria, M.D.
      • Orlando, Florida, United States, 32832
        • Recruiting
        • Conquest Research, LLC
        • Principal Investigator:
          • Jorge Fernandez-Silva, M.D.
        • Contact:
          • Jorge Fernandez-Silva, M.D.
          • Phone Number: 770-274-0827
          • Email: info@saolrx.com
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research, LLC
        • Principal Investigator:
          • Anand Patel, M.D.
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Ryan D'Souza, M.D.
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • Queen City Clinical Research, PLLC
        • Principal Investigator:
          • Christopher Gilmore, M.D.
        • Contact:
          • Christopher Gilmore, M.D.
          • Phone Number: 770-274-0827
          • Email: info@saolrx.com
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • The Center for Clinical Research
        • Contact:
        • Principal Investigator:
          • Leonardo Kapural, M.D.
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Recruiting
        • Comprehensive Specialty Care
        • Contact:
        • Principal Investigator:
          • Douglas Beall, M.D.
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Recruiting
        • Pacific Sports and Spine
        • Principal Investigator:
          • Gregory Moore, M.D.
        • Contact:
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Recruiting
        • University Orthopedics Center
        • Contact:
        • Principal Investigator:
          • Fred Khalouf, D.O.
      • Sewickley, Pennsylvania, United States, 15143
        • Recruiting
        • Pain Diagnostics & Interventional Care LLC
        • Contact:
        • Principal Investigator:
          • David Provenzano, M.D.
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina (MUSC)
        • Contact:
        • Principal Investigator:
          • Ameet Nagpal, M.D.
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • PCPMG Clinical Research Unit, LLC
        • Principal Investigator:
          • Brian Jakubowicz, M.D.
        • Contact:
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Legent Orthopedic and Spine Hospital
        • Principal Investigator:
          • Daneshvari Solanki, M.D.
        • Contact:
      • Corpus Christi, Texas, United States, 78414
        • Recruiting
        • Institute of Precision Pain Medicine
        • Principal Investigator:
          • Mitchell Engle, M.D.
        • Contact:
      • Tyler, Texas, United States, 75701
        • Recruiting
        • International Spine, Pain & Performance Center (IPP)
        • Contact:
        • Principal Investigator:
          • Aaron Calodney, M.D.
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah Orthopedic Center
        • Contact:
          • Zachary McCormick, M.D.
          • Phone Number: 770-274-0827
          • Email: info@saolrx.com
        • Principal Investigator:
          • Zachary McCormick, M.D.
    • Virginia
      • Richmond, Virginia, United States, 23238
        • Recruiting
        • Virginia iSpine Physicians, PC
        • Principal Investigator:
          • Michael DePalma, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria includes:

  1. Male or female patients ≥ 40 years of age
  2. Body Mass Index (BMI) limits
  3. Chronic knee pain resulting from osteoarthritis
  4. Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)
  5. Baseline KOOS pain
  6. Patients taking baseline analgesics
  7. Diagnostic nerve block response
  8. Compliance with identified study requirements

Exclusion Criteria includes:

  1. Non-OA inflammatory arthritis
  2. Confounding elements
  3. Lower limb amputation.
  4. Specified alternate historic treatments
  5. Identified underlying physiologic or psychosocial conditions
  6. Patient Health Questionnaire
  7. Moderate to severe hepatic impairment
  8. Moderate to severe renal impairment
  9. Identifiable baseline medications
  10. Protocol compliance requirements
  11. Known allergies or hypersensitivity to identified agents
  12. Identified alcohol or drug abuse history
  13. Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
  14. Identified underlying abnormal laboratory results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Normal saline
Drug: Normal Saline
Normal Saline
Experimental: SL1002
Drug: SL1002
SL1002 injectable solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking
Time Frame: Baseline to week 12
The pain intensity score is measured using a numeric rating scale (NRS)
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saol Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

November 6, 2025

First Submitted That Met QC Criteria

November 6, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL-1010-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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