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

NCT06522035 | Terminated Phase 1

• 1 other identifier: ENX-CL-06-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

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).

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Number and severity of AEs, SAEs and injection reactions following treatment

  12 months

Secondary Outcomes (1)

• Patient reported pain Numeric Rating Scale (NRS) in the target joint.

  3 months, 6 months and 12 months.

Other Outcomes (2)

• 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

Study Arms (2)

Stage 1

EXPERIMENTAL

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

Stage 2

EXPERIMENTAL

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

Interventions

Allocetra DRUG

Intra-articular injecton of Allocetra into the target joint.

Stage 1; Stage 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with PsA.
• 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.
• Stage 2 patients:
• At least one symptomatic joint following attempt of intra-articular injection of corticosteroids, with insufficient response.
• Acceptable blood tests- Complete Blood Count (CBC), electrolytes, adequate renal function, adequate liver function.

You may not qualify if:

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

Sponsors & Collaborators

• Enlivex Therapeutics Ltd.: lead

Study Sites (4)

Rambam Medical Center

Haifa, 3109601, Israel

Location

Carmel Medical Center

Haifa, 3436212, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Tel Aviv Sourasky Medical Center - Ichilov

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: October 20, 2025
• Study Completion: April 8, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IL (4)