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

Phase 1

Recruiting

• Conditions: Arthritis, Psoriatic
• Interventions: Drug: Allocetra

• Registration Number: NCT06522035
• Lead Sponsor: Enlivex Therapeutics Ltd.

Brief Summary

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).

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 Timeline

• Study First Submitted: 2024-07-07
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Study Start: 2024-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stage 1	Allocetra	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.
Stage 2	Allocetra	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.

Primary Outcome Measures

Name	Time	Method
Primary outcome	12 months	Number and severity of AEs, SAEs and injection reactions following treatment

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Carmel Medical Center; 🇮🇱 Haifa, Israel

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Tel Aviv Sourasky Medical Center - Ichilov; 🇮🇱 Tel Aviv, Israel