Clinical trial NCT06522035: Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Official title: Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Arthritis, Psoriatic
Lead sponsor: Enlivex Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary outcome
timeFrame: 12 months
Secondary outcomes:
measure: Patient reported pain Numeric Rating Scale (NRS) in the target joint.
timeFrame: 3 months, 6 months and 12 months.
Other outcomes:
measure: Exploratory outcome- assessment of change from baseline in Psoriasis Area and Severity Index (PASI).
timeFrame: 12 months
measure: Exploratory outcome- assessment of change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA) score.
timeFrame: 12 months
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center - Ichilov
Study officials:
References: