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Osteoarthritis of the KneesPhase 2NCT07550231

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

A Phase 2 study testing AD-211-L, AD-211-M and AD-211-H in people with Osteoarthritis of the Knees, run by Addpharma Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Osteoarthritis of the Knees
What is being tested?
AD-211-L, AD-211-M and AD-211-H
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
No sites listed yet
Study dates
Jun 2026to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hyeji Lee contact

+82318915604

hjlee@addpharma.co.kr

About this study

Official title: 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.

Read the detailed description

Osteoarthritis of the knee

Being tested
AD-211-L, AD-211-M, AD-211-H, AD-2113, Placebo to AD-211-L/M

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AD-211-LDrug

    Per oral, 1 tablet twice daily during the treatment period.

  • AD-211-MDrug

    Per oral, 1 tablet twice daily during the treatment period.

  • AD-211-HDrug

    Per oral, 1 tablet twice daily during the treatment period.

  • AD-2113Drug

    Per oral, 1 tablet twice daily during the treatment period.

  • Placebo to AD-211-L/MDrug

    Per oral, 1 tablet twice daily during the treatment period.

  • Placebo to AD-211-HDrug

    Per oral, 1 tablet twice daily during the treatment period.

  • Placebo to AD-2113Drug

    Per oral, 1 tablet twice daily during the treatment period.

Study groups in NCT07550231
Study groupRoleWhat they receive
AD-211-L GroupExperimental1 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).
Receives: Drug: AD-211-L; Drug: Placebo to AD-211-H; Drug: Placebo to AD-2113
AD-211-M GroupExperimental1 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).
Receives: Drug: AD-211-M; Drug: Placebo to AD-211-H; Drug: Placebo to AD-2113
AD-211-H GroupExperimental1 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).
Receives: Drug: AD-211-M; Drug: AD-211-H; Drug: Placebo to AD-211-L/M; Drug: Placebo to AD-2113
AD-2113 GroupActive comparator1 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).
Receives: Drug: AD-2113; Drug: Placebo to AD-211-L/M; Drug: Placebo to AD-211-H

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in 100 mm Pain VAS score during activity over the past 24 hours in the target knee

    Measured: Baseline to Week13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07550231
Sponsor's protocol ID
AD-211P2
Status last verified
Apr 2026
First submitted
20 Apr 2026
Last updated
24 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD-211-L, AD-211-M and AD-211-H in people with Osteoarthritis of the Knees, run by Addpharma Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hyeji Lee (+82318915604, hjlee@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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