Status:
RECRUITING
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Lead Sponsor:
Enlivex Therapeutics Ltd.
Conditions:
Arthritis, Psoriatic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 untreate...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06522035
Start Date
August 1 2024
End Date
September 1 2026
Last Update
August 19 2025
Active Locations (4)
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1
Rambam Medical Center
Haifa, Israel, 3109601
2
Carmel Medical Center
Haifa, Israel, 3436212
3
Meir Medical Center
Kfar Saba, Israel, 4428164
4
Tel Aviv Sourasky Medical Center - Ichilov
Tel Aviv, Israel, 6423906