Arthritis, PsoriaticPhase 1NCT06522035
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
A Phase 1 study testing Allocetra in people with Arthritis, Psoriatic, run by Enlivex Therapeutics Ltd. at 4 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- Allocetra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 4 sitesIsrael
- Study dates
- 1 Aug 2024to 8 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Rambam Medical Center
Haifa, 3109601
Carmel Medical Center
Haifa, 3436212
Meir Medical Center
Kfar Saba, 4428164
Tel Aviv Sourasky Medical Center - Ichilov
Tel Aviv, 6423906
About this study
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).
Read the 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.
- Conditions
- Arthritis, Psoriatic
- Being tested
- Allocetra
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllocetraDrug
Intra-articular injecton of Allocetra into the target joint.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Allocetra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Number and severity of AEs, SAEs and injection reactions following treatment
Measured: 12 months
Secondary outcomes (1)
Patient reported pain Numeric Rating Scale (NRS) in the target joint.
Evaluation of change from baseline in patient reported pain Numeric Rating Scale (NRS) in the target joint.
Measured: 3 months, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Aug 2024
- Primary completion20 Oct 2025
- Study completion8 Apr 2026
Why it stopped: reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enlivex Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522035
- Sponsor's protocol ID
- ENX-CL-06-001
- Status last verified
- Apr 2026
- First submitted
- 7 Jul 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT06522035
- Acronym / sponsor ID
- ENX-CL-06-001
- Conditions
- Arthritis, Psoriatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: reprioritization
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Enlivex Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | Experimental | Drug: AllocetraStage 1 will include patients who have been treated with standard PsA therapies, and are insufficiently responsive to treatment in one or more involved joints. |
| Stage 2 | Experimental | Drug: AllocetraStage 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllocetraIntra-articular injecton of Allocetra into the target joint. | Drug | Stage 1, Stage 2 |
Primary outcome
Primary outcome
Time frame: 12 months
Number and severity of AEs, SAEs and injection reactions following treatment
1 secondary outcome
Patient reported pain Numeric Rating Scale (NRS) in the target joint.
Time frame: 3 months, 6 months and 12 months.
Results and safety
The study was stopped early (reason given: reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allocetra in people with Arthritis, Psoriatic, run by Enlivex Therapeutics Ltd. at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: reprioritization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.