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Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

24. august 2026 oppdatert av: Enlivex Therapeutics Ltd.

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to evaluate intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Knee osteoarthritis is a degenerative disease driven by physical breakdown of the joint cartilage, together with a chronic inflammation within the knee space. Over time, many patients will develop worsening pain in the joint and functional impairment, which may ultimately require knee replacement.

Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.

The main goal of this Phase IIb clinical trial is to evaluate the efficacy of intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA), in comparison to Placebo (a look-alike substance that contains no drug). Participants will be randomized 1:1 to Allocetra or Placebo. Treatment consists of a total of three ultrasound-guided intra-articular (IA) injections (Days 0, 14, 28). Follow-up will continue for 12 months.

Studietype

Intervensjonell

Registrering (Antatt)

270

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Danmark
      • Gandrup, Danmark, 9362
        • Rekruttering
        • Sanos Clinic Gandrup
        • Ta kontakt med:
        • Hovedetterforsker:
          • Søren R Bro, MD
      • Herlev, Danmark, 2730
        • Rekruttering
        • Sanos Clinic Herlev
        • Ta kontakt med:
        • Hovedetterforsker:
          • Linda Bracher, MD
      • Vejle, Danmark, 7100
        • Rekruttering
        • Sanos Clinic Vejle
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sidsel Boll, MD
  • Forente stater
    • Florida
      • Longwood, Florida, Forente stater, 32750
        • Rekruttering
        • Future Medical Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mayra Abreu, MD
      • Miami, Florida, Forente stater, 33166
        • Rekruttering
        • South Florida Research Phase I-IV
        • Ta kontakt med:
        • Hovedetterforsker:
          • Eduardo Viera, MD
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70115
        • Rekruttering
        • DelRicht Research @ Touro Medical Center
        • Hovedetterforsker:
          • Patrick Dennis, MD
        • Ta kontakt med:
    • Michigan
      • Troy, Michigan, Forente stater, 48085
        • Rekruttering
        • Oakland Medical Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jay Sandberg, MD
  • Polen
      • Bytom, Polen, 41-902
        • Har ikke rekruttert ennå
        • NZOZ Bif-Med. s.c
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hanna Mastalerz, MD
      • Katowice, Polen, 40-748
        • Har ikke rekruttert ennå
        • Vita Longa Sp. z o.o.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Barbara Stasiuk, MD
      • Krakow, Polen, 30-363
        • Har ikke rekruttert ennå
        • Centrum Medyczne Plejady
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alicja Włoch, MD
      • Poznan, Polen, 60-218
        • Rekruttering
        • Medyczne Centrum Hetmańska
        • Ta kontakt med:
        • Hovedetterforsker:
          • Piotr Leszczyński, MD
      • Poznan, Polen, 60-446
        • Har ikke rekruttert ennå
        • Reumedika sp. z o.o.
        • Ta kontakt med:
        • Hovedetterforsker:
          • Wieslawa Porawska, MD
      • Radom, Polen, 26-610
        • Har ikke rekruttert ennå
        • DC-MED Michal Kowalski S.K. Radom
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tomasz Romaniuk, MD
      • Swidnica, Polen, 58-100
        • Rekruttering
        • DC-MED Michal Kowalski S.K. Swidnica
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paweł Michalec, MD
      • Warsaw, Polen, 02-677
        • Rekruttering
        • ETG Warszawa
        • Ta kontakt med:
        • Hovedetterforsker:
          • Radoslaw Gorski, MD
      • Warsaw, Polen, 01-696
        • Har ikke rekruttert ennå
        • ETG JustMed
        • Ta kontakt med:
        • Hovedetterforsker:
          • Wojciech Zakiewicz, MD
      • Wroclaw, Polen, 52-210
        • Har ikke rekruttert ennå
        • Migre Polskie Centrum
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marta Wasilewska, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

Participants must meet all of the inclusion criteria listed below to be eligible for the study:

  1. Age 64 years or above.
  2. Diagnosis of primary femorotibial knee OA.
  3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
  4. Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
  5. Index knee pain assessed during the screening period and following wash-out of pain medications.
  6. Willingness to abstain from prohibited medications/treatments during the trial.
  7. Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  8. Male participants with partners of childbearing potential, who are not surgically sterile (vasectomy) for at least 6 months prior to randomization, must use condoms with spermicide in addition to their partner's contraception from randomization and for 90 days after last dose.

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

  1. Severe or end-stage osteoarthritis of the index knee.
  2. Clinically significant structural abnormalities or instability of the index knee.
  3. Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
  4. Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
  5. Any known history of inflammatory arthropathy or crystal-deposition disease.
  6. Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
  7. Clinically significant widespread pain syndromes.
  8. Immunosuppressive therapy, clinically significant immunodeficiency, or active infection.
  9. Body Mass Index (BMI) >40 kg/m²
  10. Use of medications that may interfere with pain assessment or study outcomes.
  11. Known coagulopathy or use of anticoagulant/antiaggregant medication.
  12. Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Allocetra
Three intra-articular injections of Allocetra at a selected dose, into the index knee.
Legemiddel: Allocetra
Allocetra is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state.
Placebo komparator: Placebo
Three intra-articular injections of placebo into the index knee.
Annen: Placebo
Kontrollen som brukes i denne studien vil være placebo. Placebooppløsning som inneholder alle hjelpestoffer bortsett fra Allocetra-cellene.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months
Tidsramme: 3 months.
The change from baseline of the WOMAC Pain score at 3 months between Allocetra and Placebo. Total Pain score ranges from 0 (No pain) to 50 (Extreme pain).
3 months.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score at 3 months
Tidsramme: 3 months.
The change from baseline for the WOMAC Function score at 3 months between Allocetra and Placebo. Total Function score ranges from 0 (No difficulty) to 170 (Extreme difficulty).
3 months.
Primary Safety Endpoint
Tidsramme: Day 0 to 6 months.
Incidence and severity of Adverse Events (AEs) up to 6 months. AE incidence will be represented as % per study group and AE severity will be represented as mild, moderate or severe.
Day 0 to 6 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score
Tidsramme: 6 months.
The change from baseline of the WOMAC Pain score at 6 months. Total Pain score ranges from 0 (No pain) to 50 (Extreme pain).
6 months.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score
Tidsramme: 6 months.
The change from baseline of the WOMAC Function score at 6 months. Total Function score ranges from 0 (No difficulty) to 170 (Extreme difficulty).
6 months.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total score
Tidsramme: 3 months, 6 months.
The change from baseline for the WOMAC Total score at 3 and 6 months. Total score ranges from 0 to 240 when higher score means worse outcomes.
3 months, 6 months.
Average Daily Pain Numerical Rating Scale (ADP-NRS)
Tidsramme: 3 months, 6 months.
The change from baseline of the Average Daily Pain Numerical Rating Scale (ADP-NRS) at 3 and 6 months. ADP-NRS score ranges from 0 (No pain) to 10 (Worst imaginable pain).
3 months, 6 months.
Outcome Measures in Rheumatology and Osteoarthritis Research Society International (OMERACT-OARSI) score
Tidsramme: 3 months, 6 months.
Treatment responders at 3 and 6 months according to the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) criteria. OMERACT-OARSI score will be represented as % when higher scores means a better outcome.
3 months, 6 months.
Euro Quality of Life-5-Dimension (EQ-5D) index scores
Tidsramme: 3 months, 6 months.
Change from baseline in Euro Quality of Life-5-Dimension (EQ-5D) index scores at 3 and 6 months. EQ-5D index scores in composed of an index value which range from 0 to 1 and EQ VAS score which range from 0 to 100. In both a higher score means better outcomes.
3 months, 6 months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Enlivex Therapeutics Ltd.

Samarbeidspartnere

Nordic Bioscience Clinical Development (NBCD)

Etterforskere

  • Studieleder: Lital Weinfeld Bergman, Senior Director of Clinical Operations

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

23. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ENX-CL-05-002

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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