A study to learn about the efficacy and safety of 4P004 in participants with knee synovitis and osteoarthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

4moving Biotech

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

29 Sep 2025 → ongoing

Decision date (initial)

2025-08-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

4Moving Biotech SAS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

To assess the efficacy of 4P004 on OA pain in the target knee (TK) at Week (W) 4

Secondary objectives 3

1. To assess the efficacy of 4P004 on Patient Centric data over time on - TK pain - TK pain in a nominated pain-aggravating activity (from WOMAC Pain subscale) - Symptoms and functional impairment - Global assessment of OA
2. To evaluate the number of responders with respect to OA pain and function
3. To evaluate safety and tolerability

Conditions and MedDRA coding

knee synovitis and osteoarthritis

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male and female participants can take part in this study if they: • are aged between 40 and 80 years,
2. • weigh over 40 kilograms (kg),
3. • have a body mass index (BMI, the ratio of height to bodyweight) between 18.5 and 35,
4. • are able to walk unaided, or with the assistance of a cane,
5. • have had OA pain in the knee to be treated for at least 6 months before taking part,
6. • have synovitis of the knee to be treated, assessed by magnetic resonance imaging (MRI), and
7. • meet certain requirements related to their OA/synovitis diagnosis and pain levels.
8. Please see protocol for a detailed list of inclusion criteria.

Exclusion criteria 11

1. Pregnant or breastfeeding women.
2. Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus > 10°, valgus > 10°) by radiography.
3. Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.
4. Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.
5. Any partial knee replacement of the TK.
6. Acute fracture or IA trauma to the TK within 12 months prior to the screening visit.
7. Major knee surgery performed within the previous 12 months or planned during the trial.
8. Arthroscopy of the TK within 6 months prior to the screening visit.
9. Presence of any painful conditions that could confound accurate assessment of pain from OA in the TK, such as fibromyalgia, peripheral neuropathy or vascular insufficiency.
10. Treatment with systemic corticosteroids (other than IA) at a dose greater than 10 mg prednisone or the equivalent per day for more than 7 days within 4 weeks prior to the screening visit.
11. Please see protocol for a detailed list of exclusion criteria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from Baseline at W4 in the weekly average of TK daily pain intensity using the WOMAC Pain subscore

Secondary endpoints 6

1. Change from Baseline at W2, W6, W8, W10 and W12: - Weekly average of TK daily pain (WOMAC Pain)
2. Change from Baseline at W2, W4, W8 and W12: - NRS (0-10) pain in a nominated pain aggravating activity - WOMAC subscores and total score - Patient Global Assessment of OA (PGA-OA)
3. % of OMERACT-OARSI Responders at W2, W4, W8 and W12
4. Incidence and severity of TEAEs during the trial
5. Absolute values and changes from Baseline in: - Clinical laboratory assessments (hematology, chemistry, and urinalysis) - Vital signs (systolic and diastolic blood pressure [BP], pulse rate,)
6. Directed physical examination

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

4moving Biotech

Sponsor organisation

4moving Biotech

Address

1 Rue Du Professeur Calmette

City

Lille

Postcode

59800

Country

France

Scientific contact point

Organisation

4moving Biotech

Contact name

Francis Berenbaum

Public contact point

Organisation

4moving Biotech

Contact name

Francis Berenbaum

Third parties 7

Locations

4 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 39 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications