Determining the Optimal Dose of AD-211 in Patients With Osteoarthritis of the Knee

April 20, 2026 updated by: Addpharma Inc.

A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-211 in Patients With Osteoarthritis of the Knee

The purpose of this study is to determine the optimal dose of AD-211 in patients with osteoarthritis of the knee.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis of the knee

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

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

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:

  • Signed informed consent
  • Patients with osteoarthritis of the Knee
  • Other inclusions applied

Exclusion Criteria:

  • Patients with secondary osteoarthritis of the knee
  • Other exclusions applied

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD-211-L Group
1 Week: twice daily; 2 tablets per dose (AD-211-L + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-L + placebo to AD-211-H + placebo to AD-2113).
Drug: AD-211-L
Per oral, 1 tablet twice daily during the treatment period.
Drug: Placebo to AD-211-H
Per oral, 1 tablet twice daily during the treatment period.
Drug: Placebo to AD-2113
Per oral, 1 tablet twice daily during the treatment period.
Experimental: AD-211-M Group
1 Week: twice daily; 2 tablets per dose AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-M + placebo to AD-211-H + placebo to AD-2113).
Drug: Placebo to AD-211-H
Per oral, 1 tablet twice daily during the treatment period.
Drug: Placebo to AD-2113
Per oral, 1 tablet twice daily during the treatment period.
Drug: AD-211-M
Per oral, 1 tablet twice daily during the treatment period.
Experimental: AD-211-H Group
1 Week: twice daily; 2 tablets per dose (AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-H + placebo to AD-211-L/M + placebo to AD-2113).
Drug: Placebo to AD-2113
Per oral, 1 tablet twice daily during the treatment period.
Drug: AD-211-M
Per oral, 1 tablet twice daily during the treatment period.
Drug: AD-211-H
Per oral, 1 tablet twice daily during the treatment period.
Drug: Placebo to AD-211-L/M
Per oral, 1 tablet twice daily during the treatment period.
Active Comparator: AD-2113 Group
1 Week: twice daily; 2 tablets per dose (AD-2113 + placebo to AD-211-L/M). 12 Weeks: twice daily; 3 tablets per dose (AD-2113 + placebo to AD-211-L/M + placebo to AD-211-H).
Drug: Placebo to AD-211-H
Per oral, 1 tablet twice daily during the treatment period.
Drug: Placebo to AD-211-L/M
Per oral, 1 tablet twice daily during the treatment period.
Drug: AD-2113
Per oral, 1 tablet twice daily during the treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in 100 mm Pain VAS score during activity over the past 24 hours in the target knee
Time Frame: Baseline to Week13
Baseline to Week13

Collaborators and Investigators

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

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: Jung Yoon Choi, Daegu Catholic University Medical Center

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • AD-211P2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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