4P004 for Osteoarthritis

(INFLAM MOTION Trial)

Recruiting at 20 trial locations

Overseen By Odile Fleurot, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: 4Moving Biotech

Must not be taking: Systemic corticosteroids, GLP-1 agonists

Disqualifiers: Pregnancy, Significant malalignment, Secondary OA, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

129 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 4P004 for individuals with knee osteoarthritis, a condition causing joint pain and stiffness. Researchers aim to determine if a single injection of 4P004 can safely reduce pain and improve knee function compared to a placebo, which is a harmless substance resembling the treatment. This study targets those who have experienced moderate to severe knee pain related to osteoarthritis for at least six months and have found little relief with common pain medications like acetaminophen or NSAIDs. Participants should also exhibit visible signs of knee inflammation. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective new therapy.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop certain medications before participating. You must not have taken any intra-articular injections in the knee within 24 weeks before the screening, and you should not have used glucosamine, chondroitin sulfate, or similar supplements in the last 3 months. Additionally, you cannot be on certain diabetes medications or anticoagulants.

Is there any evidence suggesting that 4P004 is likely to be safe for humans?

Research has shown that 4P004 has been tested in earlier studies to assess its safety and tolerability. These studies found that patients with knee osteoarthritis generally tolerated 4P004 well. One study focused on evaluating the safety of 4P004, and the results were positive. Patients did not experience significant negative effects, suggesting the treatment is safe at the doses tested. This is encouraging for prospective trial participants, as 4P004 has been safe for humans so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Unlike the standard treatments for osteoarthritis, which often include pain relievers or anti-inflammatory medications like NSAIDs, 4P004 offers a novel approach by directly targeting the knee joint. Researchers are excited about 4P004 because it is delivered through an intra-articular (IA) injection, which means it's administered directly into the knee. This targeted delivery could potentially provide quicker and more localized relief from the pain and stiffness associated with osteoarthritis. Additionally, the unique composition of 4P004 may offer a new mechanism to improve joint function, setting it apart from current treatment options.

What evidence suggests that 4P004 might be an effective treatment for osteoarthritis?

Research shows that 4P004, which participants in this trial may receive, might help treat knee osteoarthritis by reducing inflammation. This treatment aims to decrease swelling in the joint lining, a common occurrence with osteoarthritis. Early studies of similar treatments have found that reducing inflammation can ease pain and improve joint function. Although 4P004 is new to human trials, these early findings suggest it could effectively lessen osteoarthritis symptoms. More research is needed to confirm these results, but the mechanism of 4P004 offers a hopeful approach. ^{1 3 6 7 8}

Who Is on the Research Team?

Francis Berenbaum, MD, PhD

Principal Investigator

4

Are You a Good Fit for This Trial?

This trial is for people aged 40-80 with knee osteoarthritis (grades 2 to 4) and synovitis. Participants will receive a single injection in the affected knee joint. The study excludes specific details not provided.

Inclusion Criteria

Body mass index (BMI) ≥ 18.5 and ≤ 35

Widespread Pain Index (WPI) ≤ 4

Presence of synovitis in the TK assessed locally using PDUS

Exclusion Criteria

Pregnant or breastfeeding women

Significant malalignment of anatomical axis of the TK

Any significant psychiatric illness unless well controlled since at least 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one single intra-articular injection of 4P004 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits at Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12

What Are the Treatments Tested in This Trial?

Interventions

• 4P004

Trial Overview The trial tests the safety and effectiveness of a new treatment, an intra-articular injection called 4P004, compared to a placebo (saltwater solution). It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment.

How Is the Trial Designed?

Group I: 4P004 (2mL) Experimental Treatment 1 Intervention

One IA injection in the knee of 4P004 (2mL) on the day of randomization

Group II: Placebo (NaCl 0.9% 2mL) Placebo Group 1 Intervention

One IA injection in the knee of Placebo (NaCl 0.9% 2mL) on the day of randomization

Who Is Running the Clinical Trial?

4Moving Biotech

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. 4movingbiotech.com 4movingbiotech.com/2025/07/16/4moving-biotech-enrolls-first-patient-in/

4Moving Biotech Enrolls First Patient in Phase 2a Trial of ... A total of 129 patients worldwide diagnosed with knee OA will be enrolled to evaluate, for the first time in humans, the efficacy of 4P004.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07225829

Study Details | NCT07225829 | A Trial to Investigate the ... See Delay Results Type in the Results Data ... Efficacy and Safety of Intra-articular 4P004 in Subjects With Knee Synovitis and Osteoarthritis.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05419856

Study Details | NCT05419856 | Safety, Tolerability and ... This phase I study is a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending dose of IA ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2665913125000081

The inflammatory endotype in osteoarthritis: Reflections ... Several trials have examined whether targeting cytokines TNFα or IL-1 would improve pain in OA; some of these studies analyzed structural progression outcomes.

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/4moving-biotech-osteoarthritis/

4Moving Biotech shares innovative trial plans for GLP-1 ... 4Moving Biotech is already laying out plans for the upcoming Phase IIb trial investigating 4P004 (liraglutide) in knee osteoarthritis.

6. 4movingbiotech.com 4movingbiotech.com/

Home | 4Moving ... safety and tolerability of 4P004 in osteoarthritis patients. Utilizing AI technology and insights from 11.4 million patients, we conducted an in-silico ...

7. ctv.veeva.com ctv.veeva.com/study/safety-tolerability-and-pharmacokinetics-of-intra-articular-ia-single-ascending-dose-of-4p-004-in

Safety, Tolerability and Pharmacokinetics of Intraarticular ... Safety, Tolerability and Pharmacokinetics of Intraarticular 4P004 Single Dose in Patient With KL 2-4 Osteoarthritic Knee (LASARE) · Timeline.

8. synapse.patsnap.com synapse.patsnap.com/article/4moving-biotech-reports-successful-phase-i-4p004-trial-of-intraarticular-liraglutide-for-knee-osteoarthritis

4Moving Biotech reports successful Phase I 4P004 trial of ... The primary objective was achieved, demonstrating that 4P004 is safe and well-tolerated. The study also identified a pharmacologically active ...