Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis

This is an open label study to evaluate the safety and initial efficacy of intra-articular administration of Allocetra in patients with Psoriatic Arthritis (PsA).

Study Overview

• Status: Terminated
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Allocetra

Detailed Description

Psoriatic Arthritis (PsA) is a prevalent chronic inflammatory disease that mainly affects the synovial joints, and leads to inflammatory arthritis, in addition to skin manifestations. If left untreated, inflammatory arthritis leads to joint damage and deformities.

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.

As macrophages play a crucial role in the initiation of PsA immunopathogenesis, they are considered an emerging target for PsA treatment.

This study will assess the safety of Allocetra injection to the joint (knee, elbow or ankle) in patients with PsA, and evaluate the preliminary responses to treatment.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Haifa, Israel, 3436212
    • Carmel Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center - Ichilov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with PsA.

2. Stage 1 patients:

   At least one joint resistant to standard PsA treatments and on a stable dose of approved PsA treatment for at least 3 months prior to treatment.

3. Stage 2 patients:

   At least one symptomatic joint following attempt of intra-articular injection of corticosteroids, with insufficient response.

4. Acceptable blood tests- Complete Blood Count (CBC), electrolytes, adequate renal function, adequate liver function.

Exclusion Criteria:

1. Prior intra-articular injection to the target joint of steroids, hyaluronate or other drugs within 3 months prior to treatment.
2. Any significant injury to the target joint within the 6 months prior to treatment, or any surgery to the target joint within the 12 months prior to treatment.
3. Findings of acute fractures, severe loss of bone density, chondrocalcinosis and/or severe bone or joint deformity in the target joint.
4. Evidence of active local infection in the target joint.
5. Concomitant rheumatic, inflammatory or autoimmune disease other than PsA.
6. Other limb pain of unknown etiology.
7. Any evidence of clinically significant active infection.
8. Major medical condition as detailed in the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1; Stage 1 will include patients who have been treated with standard PsA therapies, and are insufficiently responsive to treatment in one or more involved joints.	Drug: Allocetra; Intra-articular injecton of Allocetra into the target joint.
Experimental: Stage 2; Stage 2 will include patients with oligoarticular PsA (1-4 joints involved), who have received at least one injection of corticosteroids to the target joint with insufficient response.	Drug: Allocetra; Intra-articular injecton of Allocetra into the target joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	Number and severity of AEs, SAEs and injection reactions following treatment	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported pain Numeric Rating Scale (NRS) in the target joint.	Evaluation of change from baseline in patient reported pain Numeric Rating Scale (NRS) in the target joint.	3 months, 6 months and 12 months.

Other Outcome Measures

Outcome Measure	Time Frame
Exploratory outcome- assessment of change from baseline in Psoriasis Area and Severity Index (PASI).	12 months
Exploratory outcome- assessment of change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score.	12 months

Collaborators and Investigators

• Sponsor: Enlivex Therapeutics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): April 8, 2026

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic
• Other Study ID Numbers: ENX-CL-06-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No