Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Et forsøg til at undersøge sikkerheden og effektiviteten af intraartikulær 4P004-injektion hos patienter med knæsynovitis og osteoartrit (INFLAM MOTION)

22. oktober 2026 opdateret af: 4Moving Biotech

Et multicenter, randomiseret, dobbeltblindt, placebokontrolleret, proof of concept-studie for at undersøge effektiviteten og sikkerheden af intraartikulær 4P004 hos patienter med knæsynovitis og osteoartrit

This phase 2a trial is an international, multicenter, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of one single intra-articular (IA) injection of 4P004 or placebo in:

  • patients between 40 and 80 years of age,
  • with synovitis and grade 2 to 4 osteoarthritis (OA) of the knee according to Kellgren and Lawrence (KL) classification.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

130

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
      • Ajax, Canada
        • Durham Bone and Joint Specialists
      • London, Canada
        • SJHC London Rheumatology Centre
      • Québec, Canada
        • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc
  • Danmark
      • Frederiksberg, Danmark
        • Parker Institute Bispebjerg, Frederiksberg Hospital
      • Herlev, Danmark
        • Sanos Clinic Herlev
  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85712-2805
        • Tucson Orthopaedic Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University Feinberg School of Medicine
    • Massachusetts
      • Burlington, Massachusetts, Forenede Stater, 01803
        • Skylight Health Research Burlington
  • Frankrig
      • Montpellier, Frankrig
        • CHU Montpellier
      • Nice, Frankrig
        • ChU de Nice
      • Paris, Frankrig
        • Hôpital Lariboisière
      • Paris, Frankrig
        • Hôpital Cochin
      • Reims, Frankrig
        • Centre Hospitalier Universitaire CHU de Reims - Hopital Maison Blanche
  • Polen
      • Krakow, Polen
        • Care Access Kraków
      • Warsaw, Polen
        • Centrum Medyczne Reuma Park
      • Warsaw, Polen
        • MICS Centrum Medyczne Warszawa
  • Spanien
      • A Coruña, Spanien
        • Complejo Hospitalario Universitario de A Coruna - Hospital Universitario de A Coruna
      • A Coruña, Spanien, 15702
        • Clínica Gaias Santiago
      • Alicante, Spanien
        • HLA Clínica Vistahermosa
      • Sabadell, Spanien
        • Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
      • Santiago de Compostela, Spanien
        • Clinica Nuestra Senora de la Esperanza
      • Seville, Spanien
        • Hospital Quirónsalud Sagrado Corazón

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participants who have the capacity to give informed consent and who are willing to comply with all trial related procedures and assessments.
  • Participants between 40 and 80 years of age.
  • Female participant of childbearing potential (defined as any woman unless postmenopausal for at least one year or surgically sterile) must use highly effective methods of contraception as defined in the protocol. Highly effective contraceptive measures must be continued throughout the trial until the final visit.
  • Bodyweight > 40 kg.
  • Body mass index (BMI) ≥ 18.5 and ≤ 35.
  • Ambulatory (single assistive devices such as canes allowed).
  • Widespread Pain Index (WPI) ≤ 4.
  • Pain NRS (0-10) < 4 in the contralateral knee.
  • History of OA-related pain of the TK for at least 6 months.
  • Moderate to severe pain of the TK the majority of days during the last 3 months as per participant's judgement.
  • Moderate to severe pain of the TK on the WOMAC Pain subscale prior to the Randomization visit (V2) complying with: a) Complete WOMAC Pain diary for at least 7 of the last 10 days prior to V2 (including V2/D1 rating which is mandatory), and b) Diary reported WOMAC Pain between 5 and 9 for at least 7 of the last 10 days.
  • History of insufficient pain relief, intolerance, or contraindication to NSAIDs, and at least a history of insufficient pain relief from at least one of the following therapies: a) Acetaminophen/paracetamol, b) Opioids including tramadol, or c) Corticosteroids, hyaluronate IA injections (efficacy less than 3 months according to the patient).
  • KL grade 2 to 4 on the Schuss radiograph.
  • Predominant femorotibial OA based on the OA Research Society International. (OARSI) Atlas reading (Altman & Gold, 2007).
  • Presence of synovitis in the TK assessed locally using PDUS, and synovial thickness of ≥ 5 mm evaluated through a longitudinal view of the suprapatellar pouch and axial views of the medial and lateral patellofemoral pouches.
  • Negative urine drug screen (performed locally): amphetamines, barbiturates, cocaine.
  • CE-MRI Central reading to confirm synovitis with a synovial Semi-Quantitative (SQ) ≥ 9 or a SQ score ≥7 with at least one site with a score ≥ 2.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus > 10°, valgus > 10°) by radiography.
  • Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.
  • Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.
  • Any partial knee replacement of the TK.
  • Acute fracture or IA trauma to the TK within 12 months prior to the screening visit.
  • Major knee surgery performed within the previous 12 months or planned during the trial.
  • Arthroscopy of the TK within 6 months prior to the screening visit.
  • 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.
  • 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.
  • Treatment of the TK with any IA injection (including corticosteroids, hyaluronic acid derivatives, Platelet Rich Plasma….) within 24 weeks prior to the screening visit.
  • Any treatment with glucosamine, chondroitin sulfate, or other nutraceuticals with potential activity on OA within the previous 3 months prior to the screening visit.
  • Treatment with duloxetine for OA (allowed if given for depressive disorders at stable dose since at least 3 months before V1).
  • Any significant psychiatric illness unless well controlled since at least 6 months.
  • Current treatment with combination of insulin and liraglutide (Xultophy®) or with GLP-1 agonist administered once a week (semaglutide, dulaglutide).
  • High-risk of bleeding.
  • Congestive Heart Failure stage III or IV in the New York Heart Association classification.
  • History or current diagnosis of electrocardiogram ECG abnormalities indicating significant safety risk (such as ischemia, significant cardiac arrhythmias).
  • Glycemia < 4.4 mmol/L (or 80 mg/dL) at screening.
  • Clinically significant abnormal laboratory test at screening, in particular: haemoglobin <10 g/dL, white blood cell <3000/µL (3.0 Giga/L), absolute neutrophil count <1000/µL (1.0 Giga/L), platelets count <100,000/µL (100 Giga/L), alanine aminotransferase or aspartate aminotransferase >2.5 upper limit of normal (ULN), total bilirubin >1.5 ULN, lipasemia >1 ULN.
  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, using Chronic Kidney Disease - EPIdemiology (CKD EPI) 2021 Formula.
  • Any other abnormal laboratory results that the Investigator believes should preclude the subject's participation in the trial.
  • History of hypersensitivity to IMP or excipients (liraglutide or disodium phosphate dihydrate, propylene glycol, phenol).
  • Any contraindication for MRI (cardiac pacemaker, deep brain stimulators, intraocular metal, cerebral aneurysm clips, recent stents, cochlear implants, neurostimulators and implantable pumps) or inability to undergo MRI (e.g., body size, leg not fitting in the coil, claustrophobia).
  • History of hypersensitivity reactions to a gadolinium-based contrast agent.
  • Any CE-MRI Central reading additional diagnoses: posterior meniscal root tears, subchondral insufficiency fractures, osteonecrosis, malignant bone marrow infiltration, solid tumours, and traumatic fracture or bone bruise using ROAMES (Roemer et al., 2020).
  • Previous participation in clinical research with a disease-modifying OA drug during the last 2 years.
  • Participation in an interventional clinical research trial within 3 months before screening.
  • Participants who, in the investigator's judgement, are at risk of falling.
  • Participants with a history, or current diagnosis, of pancreatitis, thyroid cancer (including medullary thyroid carcinoma), multiple endocrine neoplasia type-2 (MEN2), diabetic ketoacidosis, type-1 diabetes mellitus (T1DM), inflammatory bowel disease, or diabetic gastroparesis.
  • Participants currently, or within the last 10 days, taking any anticoagulant treatment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 4P004 (2mL)

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

Single intra-articular injection in the knee joint

Andre navne:
  • Liraglutid
Placebo komparator: Placebo (NaCl 0.9% 2mL)

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

Single intra-articular injection in the knee joint

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline at Week 4 in the weekly average of Target Knee (TK) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
Tidsramme: Baseline and Week 4

The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score.

Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Baseline and Week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel (%) af OMERACT-OARSI-respondenter ved uge 2, uge 4, uge 8 og uge 12
Tidsramme: Uge 2, Uge 4, Uge 8 og Uge 12
Uge 2, Uge 4, Uge 8 og Uge 12
Forekomst og sværhedsgrad af TEAEs (behandlingsfremkaldte bivirkninger) under forsøget
Tidsramme: Fra randomisering til afslutning af forsøget, op til 12 uger
Fra randomisering til afslutning af forsøget, op til 12 uger
Absolutte ændringer fra baseline i klinisk laboratorievurdering - hæmatologiparameter: totalt blodcelleantal (i celle/L)
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Absolutte ændringer fra baseline i kliniske laboratorieundersøgelser - hæmatologiparameter: hæmoglobin (i g/L)
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Absolute ændringer fra baseline i kliniske laboratorieundersøgelser - blodkemi: AST (i U/L)
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Absolutte ændringer fra baseline i kliniske laboratorieundersøgelser - blodkemi: ALT (i U/L)
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Absolutte ændringer fra baseline i kliniske laboratorievurderinger - blodkemi: lipase (i U/L)
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Absolutte ændringer fra baseline i kliniske laboratorieundersøgelser - blodkemi: fastende glykæmi (i mmol/L)
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Absolutte ændringer fra baseline i kliniske laboratorieundersøgelser - blodkemi: totalt bilirubin (i µmol/L)
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Absolutte ændringer fra baseline i vitale tegn: systolisk og diastolisk blodtryk (BP)
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Absolutte ændringer fra baseline i vitale tegn: puls
Tidsramme: Fra randomisering til afslutning af forsøget (op til 12 uger)
Fra randomisering til afslutning af forsøget (op til 12 uger)
Change from Baseline at Week 2, Week 6, Week 8, Week 10 and Week 12 in the weekly average of TK (Target Knee) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
Tidsramme: Baseline, Week 2, Week 6, Week 8, Week 10 and Week 12

The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score.

Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Baseline, Week 2, Week 6, Week 8, Week 10 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the NRS (Numeric Rating Scale) pain (scale 0-10) in a nominated pain aggravating activity
Tidsramme: Baseline, Week 2, Week 4, Week 8 and Week 12

The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time, using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Baseline, Week 2, Week 4, Week 8 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in WOMAC (Western Ontario and McMaster Universities Arthritis Index) subscores and total score
Tidsramme: Baseline, Week 2, Week 4, Week 8 and Week 12

The WOMAC is a questionnaire widely used in the evaluation of knee osteoarthritis. It contains 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores are calculated for each subscale and summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score.

Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Baseline, Week 2, Week 4, Week 8 and Week 12
Change from Baseline at Week 2, Week 4, Week 8 and Week 12 in the Patient Global Assessment of Osteoarthritis (PGA-OA)
Tidsramme: Baseline, Week 2, Week 4, Week 8 and Week 12

The PGA-OA is a 1-item questionnaire designed to assess the participant's impression of disease severity adapted from Guy et al., 1976, to the specific disease as a Patient-reported Outcome measurement "Considering all the ways your knee osteoarthritis affects you, how are you doing these last seven days ?".

PGA-OA is measured on a 5-point Likert scale, with higher scores indicating worse symptoms (1= "very good" to 5 = "very poor").
Baseline, Week 2, Week 4, Week 8 and Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

4Moving Biotech

Efterforskere

  • Studiestol: Francis Berenbaum, MD, PhD, 4

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juni 2025

Primær færdiggørelse (Faktiske)

31. august 2026

Studieafslutning (Faktiske)

19. oktober 2026

Datoer for studieregistrering

Først indsendt

24. september 2025

Først indsendt, der opfyldte QC-kriterier

5. november 2025

Først opslået (Faktiske)

10. november 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4MB-4P004-P-INFLAM
  • 2024-518916-38-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner