Rheumatoid Arthritis (RA)Phase 1DekaJointNCT07245992
A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis
A Phase 1 study testing F8IL10 in people with Rheumatoid Arthritis (RA), run by Philogen S.p.A. at 2 sites in Italy.
Trial summary
The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- F8IL10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesItaly
- Study dates
- 4 Mar 2026to 30 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 and ≤80 years.
- Diagnosis of RA according to ACR/EULAR classification criteria (2010) with a disease duration exceeding 6 months.
- Presence of arthritis flare(s) suitable for IA injection in a knee, ankle, shoulder, wrist or elbow, despite treatment with stable doses (for at least 3 months) of DMARDs (conventional, biologic, and targeted synthetic) background therapy.
- No or stable regimens of NSAIDs and/or oral corticosteroid (≤ 10 mg/day; prednisone equivalent) for a period ≥2 weeks prior to screening.
- All acute toxic effects of any prior therapy must have resolved or returned to classification "mild" (grade 1) according to CTCAE v.5.0.
- Sufficient hematologic, liver and renal function defined as follows:
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- Absolute neutrophil count (ANC) ≥1.5 x 109/L, platelets ≥100 x109/L, haemoglobin (Hb) ≥10.0 g/dL.
- Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT) and or Aspartate Aminotransferase (AST) ≤3 x Upper Limit of Normal Range (ULN), and total bilirubin ≤2.0 mg/dl (34.2 μmol/L).
- Creatinine ≤1.5 ULN or 24 h creatinine clearance ≥50 mL/min.
- Documented negative TB test (e.g. Quantiferon or equivalent).
- Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no ongoing infection are eligible.
- Sexually active male or female patients of childbearing potential are eligible providing that:
- Women of childbearing potential (WOCBP) have a negative pregnancy test performed within 4 weeks prior to treatment start.
- WOCBP agree to use, from the screening to 6 months following the last study drug administration, effective method of birth control as applicable per local law that both results in a Pearl index <1 and considered highly effective as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the "Clinical Trial Facilitation Group" (e.g. combined estrogen and progestogen containing hormonal contraception, progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, vasectomized partner, total sexual abstinence or bilateral tubal occlusion).
- Males agree to use two acceptable methods of contraception (e.g. condom with spermicidal gel) from the screening to 6 months following the last study drug administration. Females of childbearing potential that are partners of male study participants must observe the same birth control indications that apply to female participants.
- Signed and dated Ethics Committee-approved informed consent form indicating that the patient, or patient's legally acceptable representative, has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- Presence of additional RA flares or RA-related symptoms that, in the investigator's judgment, are likely to require local treatment during the study (defined as intra-articular or peri-articular injections/procedures intended to treat RA; e.g., joint, tendon-sheath, or bursal corticosteroid injections; hyaluronic acid; biologic/PRP injections; or radio synovectomy)._
- Presence of active infections or another severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or would interfere with the study objectives or conduct.
- Pregnancy, lactation or unwillingness to use adequate contraceptive methods.
- Diagnosis of any other inflammatory arthritis or active autoimmune diseases other than RA.
- Any therapy for RA apart from the allowed background therapy (i.e., stable doses of DMARDs, corticosteroids, and/or NSAIDs) within 4 weeks prior to the first IMP dosing.
- Received intra-articular administration of corticosteroids/DMARDs within 4 weeks or 5 half-lives prior to the first IMP dosing, whichever is longer.
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- History or currently active primary or secondary immunodeficiency.
- Concurrent malignancy or history of malignancy (except in situ melanoma and low-risk non melanoma skin cancer) from which the patient has been disease-free for less than 2 years.
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- Treatment with warfarin or other coumarin derivatives.
- Clinically significant cardiac arrhythmias or requiring permanent medication.
- Abnormalities in baseline ECG analysis that are considered as clinically significant by the investigator; subjects with current or a history of QT/QTc prolongation.
- Uncontrolled hypertension, despite optimal treatment.
- Known arterial aneurism at high risk of rupture.
- Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche Fontaine classification).
- Severe diabetic retinopathy.
- Major trauma including surgery within 4 weeks prior to administration of study treatment.
- Known history of allergy/hypersensitivity or other intolerance to any component of F8IL10 (including excipients) or to other drugs based on human proteins/peptides/antibodies.
- Treatment with any investigational agent within 4 weeks or 5 half-lives prior to the first dose of study drug, whichever is longer.
- Immunization with a live/attenuated vaccine within 4 weeks prior to baseline or plan to receive vaccines during the study.
- Non-RA related chronic pain disorders.
- Patients requiring stable doses of corticosteroids >10 mg/day (prednisone equivalent). Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
- History of alcohol, drug or chemical substance abuse within the 6 months prior to screening.
- Any condition that in the opinion of the investigator could hamper compliance with the study protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Federica Bastioli, Pharmaceutical Chemist contact
Italy2 sites, 2 recruiting
- Not yet recruiting
Arcispedale Santa Maria Nuova
Reggio Emilia, Reggio Emilia, 42123
Filippo Crescentini
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona c/o Policlinico GB Rossi (Borgo Roma), Dep. Reumatologia
Verona, VR, 37134
Elena Fracassi
About this study
Official title: A Dose-finding Phase I Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis
The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis.
Read the detailed description
This protocol describes an open-label, non-randomized, ascending-dose Phase I study conducted in sequential cohorts of patients. The aim of the study is to assess the safety and tolerability of F8IL10 when administered via intra-articular (IA) route 3 times every 4 weeks in patients with RA.
Eligible patients are male or female, ≥18 and ≤80 years old, with Rheumatoid Arthritis (RA) who, despite treatment with stable doses for at least 3 months of DMARDs (conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for IA injection in a knee, shoulder, ankle, wrist or elbow.
The study will take place in two stages:
- The dose-escalation part is designed with an accelerated phase, followed by a classical 3+3 dose-escalation scheme. Patients will be sequentially assigned to the following F8IL10 concentration levels:
- Cohort 1: 0.05 µg/mL
- Cohort 2: 0.5 µg/mL
- Cohort 3: 5 µg/mL
- Cohort 4: 20 µg/mL
- Cohort 5: 50 µg/mL
- Cohort 6: 100 µg/mL
- Cohort 7: 150 µg/mL
- Cohort 8: 200 µg/mL The administered volume depends on the target joint: 5 mL for knee, 4 mL for shoulder, 2 mL for ankle or elbow, and 1 mL for wrist. Therefore, the actual administered dose varies according to both the cohort concentration and the joint treated.
- Following successful identification of the RD, the study will proceed with a dose-expansion part, during which 12 patients will be treated at the RD concentration level, including those already treated at that level during dose escalation.
Patients will receive intra-articular administrations of F8IL10 every 4 weeks for up to 3 administrations, at Week 1, Week 5 and Week 9. Following completion of treatment, patients will continue with Follow-up every 4 weeks from Week 13, or End of Treatment, up to Week 37, to monitor safety, treatment response and any need to introduce or modify DMARD therapy.
The primary objective is to evaluate the safety of F8IL10 when administered by IA injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD). MTD, RD and maximum administered dose (MAD) are defined as joint-independent F8IL10 concentrations applicable across all evaluated joint types.
Secondary objectives are to assess early signs of efficacy and to determine the pharmacokinetic profile and immunogenicity of intra-articular F8IL10
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- F8IL10
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F8IL10Drug
Intra-articular treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The study will take place in two stages:
1. In the dose-escalation part, participants will be enrolled in cohorts and treated at different F8IL10 concentration levels in order to identify a joint-independent recommended dose (RD), expressed as an F8IL10 concentration. In each cohort, 1 to 6 patients will be treated until the maximum administered dose (MAD) is reached.
2. Following successful identification of the RD, the study will proceed with a dose-expansion part, during which 12 patients will be treated at the RD concentration level, including those treated at that concentration during the dose-escalation part. Receives: Drug: F8IL10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Occurrence of dose limiting toxicity (DLT)
Measured: From Day 1 to Day 28 of the treatment
MAD, MTD and RD
Definition of maximum administered dose (MAD), maximum tolerated dose (MTD) and recommended dose (RD), each expressed as joint-independent F8IL10 concentrations applicable across all evaluated joint types.
Measured: From Day 1 to Day 28 of the treatment
AEs, SAEs and DILI
Adverse events (AEs), serious adverse events (SAEs) and Drug-Induced Liver Injury (DILI), based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE).
Measured: Through study completation (up to 37 weeks)
Incidence of injection site reactions
Incidence of injection site reactions and general reactions associated with intraarticular administration
Measured: Through study completation (up to 37 weeks)
Standard laboratory parameters
Standard laboratory (haematology, biochemistry, liver and urine analysis) parameters.
Measured: Through study completion (up to 37 weeks)
Secondary outcomes (6)
CCI: Composite change index
The CCI is a semiquantitative scoring system designed to assess target joint synovitis by integrating multiple clinical variables. It incorporates changes in joint pain measured by the Visual Analogue Scale (jVAS), clinical evaluation of joint swelling and tenderness, the patient's assessment of functional disability, and both patient and investigator global assessments of treatment efficacy. The resulting score ranges from 0 (no improvement) to 10 (maximal therapeutic effect).
Measured: Every 4 weeks, up to week 37
SF-36
Changes in Short Form Health Survey 36. The SF-36 is a validated, patient-reported measure of overall health status, comprising multi-item scales measuring each of the following 8 health concepts: (1) physical functioning, (2) role limitations due to physical health, (3) bodily pain, (4) social functioning, (5) emotional well-being, (6) role limitations due to emotional problems, (7) vitality (energy/fatigue), and (8) general health perceptions. Each healt concept is scored separately, with scores ranging from 0 (worst possible health status) to 100 (best possible health status).
Measured: Every 4 weeks, up to week 37
Joint inflammation
Changes in target joint inflammation (synovitis) assessed by gray-scale ultrasound (GSUS) and power doppler ultrasound (PDUS). Ultrasound assessment of the treated joint will be performed using gray-scale (to evaluate hypoechoic synovial hypertrophy) and power Doppler (to assess synovial vascularity). Semiquantitative scoring will be applied to each modality separately, as well as in a combined score, ranging from grade 0 (normal) to grade 3 (severe synovitis).
Measured: Every 4 weeks, up to week 37
SDAI
Changes in Simple Disease Activity Index. The SDAI is a validated tool for assessing rheumatoid arthritis disease activity. It sums the tender and swollen joint counts, patient and physician global assessments of disease activity, and C-reactive protein levels in serum. Scores indicate disease activity: ≤3.3 (remission), >3.3-11 (low), >11-26 (moderate), and >26 (high).
Measured: Every 4 weeks, up to week 37
Pharmacokinetic profile
Pharmacokinetic profile of intra-articular F8IL10.
Measured: Every 2 weeks, up to week 7
HAFA
Formation of human anti-fusion protein antibodies (HAFA) against F8IL10.
Measured: Every 4 weeks, up to week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start4 Mar 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The dose-escalation part of the study is designed with an accelerated phase, followed by a classical 3+3 dose-escalation scheme. During the accelerated phase, from 0.05 to 200 μg/mL F8IL10, cohorts contain one patient per concentration level until the first occurrence of a Moderate Toxicity (MT) or DLT during the observation period from Day 1 to Day 28. With the occurrence of an MT during the DLT observation period, two additional patients will be treated at the same concentration level. If these two patients do not experience an MT or DLT, the accelerated phase will continue with one patient per concentration level. With the second occurrence of an MT, in the absence of a DLT, the accelerated phase will be terminated and dose escalation will continue according to the classical 3+3 design at the next higher concentration level. With the first occurrence of a DLT, dose escalation will continue according to the classical 3+3 design
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245992
- Sponsor's protocol ID
- PH-F8IL10INTRA-03/24
- Other IDs
- 2024-517896-19-00
- Acronym
- DekaJoint
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-finding Phase I Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07245992
- Acronym / sponsor ID
- DekaJoint / PH-F8IL10INTRA-03/24
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 24 Nov 2025 (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.
The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis.
Detailed description
This protocol describes an open-label, non-randomized, ascending-dose Phase I study conducted in sequential cohorts of patients. The aim of the study is to assess the safety and tolerability of F8IL10 when administered via intra-articular (IA) route 3 times every 4 weeks in patients with RA.
Eligible patients are male or female, ≥18 and ≤80 years old, with Rheumatoid Arthritis (RA) who, despite treatment with stable doses for at least 3 months of DMARDs (conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for IA injection in a knee, shoulder, ankle, wrist or elbow.
The study will take place in two stages:
- The dose-escalation part is designed with an accelerated phase, followed by a classical 3+3 dose-escalation scheme. Patients will be sequentially assigned to the following F8IL10 concentration levels:
- Cohort 1: 0.05 µg/mL
- Cohort 2: 0.5 µg/mL
- Cohort 3: 5 µg/mL
- Cohort 4: 20 µg/mL
- Cohort 5: 50 µg/mL
- Cohort 6: 100 µg/mL
- Cohort 7: 150 µg/mL
- Cohort 8: 200 µg/mL The administered volume depends on the target joint: 5 mL for knee, 4 mL for shoulder, 2 mL for ankle or elbow, and 1 mL for wrist. Therefore, the actual administered dose varies according to both the cohort concentration and the joint treated.
- Following successful identification of the RD, the study will proceed with a dose-expansion part, during which 12 patients will be treated at the RD concentration level, including those already treated at that level during dose escalation.
Patients will receive intra-articular administrations of F8IL10 every 4 weeks for up to 3 administrations, at Week 1, Week 5 and Week 9. Following completion of treatment, patients will continue with Follow-up every 4 weeks from Week 13, or End of Treatment, up to Week 37, to monitor safety, treatment response and any need to introduce or modify DMARD therapy.
The primary objective is to evaluate the safety of F8IL10 when administered by IA injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD). MTD, RD and maximum administered dose (MAD) are defined as joint-independent F8IL10 concentrations applicable across all evaluated joint types.
Secondary objectives are to assess early signs of efficacy and to determine the pharmacokinetic profile and immunogenicity of intra-articular F8IL10
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The dose-escalation part of the study is designed with an accelerated phase, followed by a classical 3+3 dose-escalation scheme. During the accelerated phase, from 0.05 to 200 μg/mL F8IL10, cohorts contain one patient per concentration level until the first occurrence of a Moderate Toxicity (MT) or DLT during the observation period from Day 1 to Day 28. With the occurrence of an MT during the DLT observation period, two additional patients will be treated at the same concentration level. If these two patients do not experience an MT or DLT, the accelerated phase will continue with one patient per concentration level. With the second occurrence of an MT, in the absence of a DLT, the accelerated phase will be terminated and dose escalation will continue according to the classical 3+3 design at the next higher concentration level. With the first occurrence of a DLT, dose escalation will continue according to the classical 3+3 design
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: F8IL10The study will take place in two stages: 1. In the dose-escalation part, participants will be enrolled in cohorts and treated at different F8IL10 concentration levels in order to identify a joint-independent recommended dose (RD), expressed as an F8IL10 concentration. In each cohort, 1 to 6 patients will be treated until the maximum administered dose (MAD) is reached. 2. Following successful identification of the RD, the study will proceed with a dose-expansion part, during which 12 patients will be treated at the RD concentration level, including those treated at that concentration during the dose-escalation part. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients aged ≥18 and ≤80 years.
- Diagnosis of RA according to ACR/EULAR classification criteria (2010) with a disease duration exceeding 6 months.
- Presence of arthritis flare(s) suitable for IA injection in a knee, ankle, shoulder, wrist or elbow, despite treatment with stable doses (for at least 3 months) of DMARDs (conventional, biologic, and targeted synthetic) background therapy.
- No or stable regimens of NSAIDs and/or oral corticosteroid (≤ 10 mg/day; prednisone equivalent) for a period ≥2 weeks prior to screening.
- All acute toxic effects of any prior therapy must have resolved or returned to classification "mild" (grade 1) according to CTCAE v.5.0.
Key exclusion criteria (24 listed)
- Presence of additional RA flares or RA-related symptoms that, in the investigator's judgment, are likely to require local treatment during the study (defined as intra-articular or peri-articular injections/procedures intended to treat RA; e.g., joint, tendon-sheath, or bursal corticosteroid injections; hyaluronic acid; biologic/PRP injections; or radio synovectomy)._
- Presence of active infections or another severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or would interfere with the study objectives or conduct.
- Pregnancy, lactation or unwillingness to use adequate contraceptive methods.
- Diagnosis of any other inflammatory arthritis or active autoimmune diseases other than RA.
- Any therapy for RA apart from the allowed background therapy (i.e., stable doses of DMARDs, corticosteroids, and/or NSAIDs) within 4 weeks prior to the first IMP dosing.
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 |
|---|---|---|
| F8IL10Intra-articular treatment | Drug | Treatment |
Primary outcome
DLT
Time frame: From Day 1 to Day 28 of the treatment
Occurrence of dose limiting toxicity (DLT)
MAD, MTD and RD
Time frame: From Day 1 to Day 28 of the treatment
Definition of maximum administered dose (MAD), maximum tolerated dose (MTD) and recommended dose (RD), each expressed as joint-independent F8IL10 concentrations applicable across all evaluated joint types.
AEs, SAEs and DILI
Time frame: Through study completation (up to 37 weeks)
Adverse events (AEs), serious adverse events (SAEs) and Drug-Induced Liver Injury (DILI), based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE).
Incidence of injection site reactions
Time frame: Through study completation (up to 37 weeks)
Incidence of injection site reactions and general reactions associated with intraarticular administration
Standard laboratory parameters
Time frame: Through study completion (up to 37 weeks)
Standard laboratory (haematology, biochemistry, liver and urine analysis) parameters.
6 secondary outcomes
CCI: Composite change index
Time frame: Every 4 weeks, up to week 37
SF-36
Time frame: Every 4 weeks, up to week 37
Joint inflammation
Time frame: Every 4 weeks, up to week 37
SDAI
Time frame: Every 4 weeks, up to week 37
Pharmacokinetic profile
Time frame: Every 2 weeks, up to week 7
HAFA
Time frame: Every 4 weeks, up to week 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Federica Bastioli, Pharmaceutical Chemist contact
2 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 F8IL10 in people with Rheumatoid Arthritis (RA), run by Philogen S.p.A. at 2 sites in Italy.
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 17 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis Plüss (+41 43 544 88 04, louis.pluss@philogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: From Day 1 to Day 28 of the treatment). The study lists 5 primary outcomes in all. 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 14 Oct 2026.