Arthritis, Psoriatic
Conditions
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.
Interventions
DRUGAllocetra
Intra-articular injecton of Allocetra into the target joint.
Sponsors
Enlivex Therapeutics Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 12 months | Number and severity of AEs, SAEs and injection reactions following treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Israel
Outcome results
None listed