RecruitingPhase 1NCT06522035
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Sponsor
Enlivex Therapeutics Ltd.
Enrollment
6 participants
Start Date
Aug 1, 2024
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria8
- 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.
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Interventions
DRUGAllocetra
Intra-articular injecton of Allocetra into the target joint.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06522035
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