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Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

17. maj 2026 opdateret af: 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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

270

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Allocetra
Three intra-articular injections of Allocetra at a selected dose, into the index knee.
Medicin: 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.
Andet: Placebo
Den kontrol, der anvendes i denne undersøgelse, vil være placebo. Placeboopløsning indeholdende alle hjælpestoffer undtagen Allocetra-cellerne.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

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

Sponsor

Enlivex Therapeutics Ltd.

Samarbejdspartnere

Nordic Bioscience Clinical Development (NBCD)

Efterforskere

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

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)

1. maj 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ENX-CL-05-002

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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